MOUNJARO ^®

tirzepatide

Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide‑1

(GLP‑1) Receptor Agonist—Antihyperglycemic Agent

Lilly

Date of Revision: November 1, 2023

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

Read this carefully before you start taking MOUNJARO and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about MOUNJARO.

What is MOUNJARO used for?

MOUNJARO is used along with diet and exercise to:

improve blood sugar levels in adults with type 2 diabetes.

MOUNJARO is used:

alone, if you cannot take metformin; with metformin;

with metformin and a sulfonylurea;

with metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i); with basal insulin (with or without metformin).

How does MOUNJARO work?

MOUNJARO belongs to a class of medicines called GIP and GLP-1 receptor agonists. MOUNJARO lowers your blood sugar by helping your body release more insulin when your blood sugar is high. It also reduces levels of glucagon, a hormone that prevents blood sugar from decreasing too much.

What are the ingredients in MOUNJARO?

Medicinal ingredients: tirzepatide

Non-medicinal ingredients: Hydrochloric acid solution, sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, water for injection.

MOUNJARO comes in the following dosage forms:

Solution in a single-dose prefilled pen or a single-dose vial in the following strengths: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, or 15 mg/0.5 mL.

Do not use MOUNJARO if:

you are allergic to tirzepatide or to any ingredient in MOUNJARO or component of its container. you or a member of your family has ever had Medullary Thyroid Cancer (MTC). you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). you are pregnant or breast-feeding.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MOUNJARO. Talk about any health conditions or problems you may have, including if you have:

type 1 diabetes. a heart condition that causes an increase in heart rate. experienced severe allergic reactions and swelling when taking GLP-1 receptor agonist medicines. ever had diabetic ketoacidosis (increased ketones in the blood or urine).

severe problems with your stomach (gastroparesis) or food digestion. MOUNJARO slows stomach emptying so food passes more slowly through your stomach.

Other warnings you should know about:

Gallbladder Disease:

You may suddenly develop symptoms of gallbladder disease when taking MOUNJARO.

Gallbladder disease can include inflammation of the gallbladder (cholecystitis), or gallstones blocking the bile duct (biliary colic).

Symptoms may include sudden and intensifying pain in your abdomen, between your shoulder blades or your right shoulder. You should seek immediate medical attention if you experience severe abdominal pain, yellowing of your skin, or high fever with chills. If you think you might have a problem with your gallbladder, consult your healthcare professional.

Children and adolescents:

MOUNJARO is not recommended in children and adolescents under 18 years.

Pregnancy and breast-feeding:

If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.

You should not take MOUNJARO if you are pregnant. It may harm your unborn baby.

If you are able to become pregnant:

Avoid becoming pregnant while you are taking MOUNJARO. Use effective birth control during treatment and at least one month after your last dose. If you are using oral hormonal drugs as a birth control method:

Switch to a non-oral hormonal birth control medicine. Or;

Add a barrier method of birth control (e.g., condoms). Use this method for 4 weeks when beginning treatment with MOUNJARO and for 4 weeks after each time your dose is increased.

Do not breastfeed while you are taking MOUNJARO.

Driving and using machines:

Low blood sugar (hypoglycemia) may affect your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar.

See “What are possible side effects from using MOUNJARO” for the warning signs of low blood sugar.

Talk to your doctor for further information.

Pancreas problems:

Taking MOUNJARO can cause an inflamed pancreas (acute pancreatitis).

Speak to your healthcare professional if you have or have had pancreas problems such as inflammation of the pancreas.

Your healthcare professional will monitor you for any symptoms of acute pancreatitis. Speak to your healthcare professional immediately if you have severe and on-going pain in the stomach area. See “What are possible side effects from using MOUNJARO” for more symptoms of acute pancreatitis.

Serious allergic reactions:

Stop using MOUNJARO and get medical help right away if you have any symptoms of a serious allergic reaction. This can include itching, rash, or difficulty breathing. See “What are possible side effects from using MOUNJARO” for more symptoms of an allergic reaction.

Blood tests:

Your blood sugar levels should be monitored at the start of treatment if you are taking MOUNJARO with anti-diabetic medicines known as sulfonylurea or insulin. Monitoring your blood sugar levels will help reduce the risk of developing hypoglycemia (low blood sugar).

    Your Healthcare professional will monitor your blood sugar levels periodically during your treatment with

MOUNJARO.

Kidney problems:

During treatment with MOUNJARO, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhea. These side effects can cause dehydration (loss of fluids). Dehydration can lead to problems with your kidneys, such as sudden kidney failure.

It is therefore important to drink plenty of fluids to prevent dehydration.

Talk to your healthcare professional if you have any questions or concerns.

Diabetic eye disease (retinopathy):

Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. This may require treatment or lead to a loss of vision.

You should inform your doctor if you have diabetic eye disease (retinopathy) or if you experience vision problems during treatment with MOUNJARO.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MOUNJARO:

oral birth control medicines.

anti-diabetic medicines known as a sulfonylurea (e.g., glyburide, gliclazide, glimepiride) or insulin. Combining these medicines with MOUNJARO might increase the risk of getting low blood sugar. Your healthcare professional may tell you to lower your regular dose of these drugs when adding MOUNJARO treatment.      medicines that may increase your heart rate.

How to take MOUNJARO:

Take MOUNJARO exactly as your healthcare professional has prescribed. Do not change your dose or stop taking MOUNJARO without talking to your healthcare professional.

Set a reminder on a calendar to remind yourself of your weekly dose.

The pen and vial have glass parts. Handle carefully. If you drop the pen or vial on a hard surface, do not use it. Use a new pen or vial for your injection.

An Instructions for Use leaflet is enclosed with the MOUNJARO Pen or vial. Read the Instructions for Use leaflet for instructions on how to use the MOUNJARO pen or vial.

Talk to your healthcare provider about how to correctly administer MOUNJARO before you use it for the first time. If you do not understand the instructions or have any questions, talk with your doctor, diabetes nurse, or pharmacist.

You can give yourself the injection at any time of the day, with or without food.

How to inject MOUNJARO:

MOUNJARO is an injection which is given under the skin (subcutaneously). Do not inject MOUNJARO into a vein or muscle.

The best places to give yourself the injection are your stomach area (abdomen) or upper leg (thigh). Another person should give you the injection in the back of your upper arm.

Do not use the same site for each injection. Change (rotate) your injection site with each weekly injection.

Your dose of MOUNJARO may change depending on:

if you are taking other diabetic medication

your physical health (e.g., weight, illness, physical activity) your diet

Changing the day of your weekly injection:

If necessary, you can change the day of your weekly injection. There has to be at least 3 days since your last injection of MOUNJARO.

If you give yourself insulin in addition to MOUNJARO:

never mix both medications (Insulin and MOUNJARO) in the same container. Give yourself separate injections of insulin and MOUNJARO.

You may give both injections in the same body area (for example, your stomach area), but not right next to each other.

Usual adult dose:

The recommended starting dose is 2.5 mg administered once weekly subcutaneously (under the skin). After 4 weeks your dose will go up to 5 mg once weekly. If needed, the dose may be increased by 2.5 mg after at least 4 weeks on your current dose. The maximum recommended dose is 15 mg once weekly.

Overdose:

If you think you, or a person you are caring for, have taken too much MOUNJARO, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose and:

it has been 4 days (96 hours) or less since you should have used MOUNJARO, use it as soon as you remember. Then inject your next dose on your usual scheduled day.

it has been more than 4 days (96 hours) since you should have used MOUNJARO, skip the missed dose. Then inject your next dose on your usual scheduled day.

What are possible side effects from using MOUNJARO?

These are not all the possible side effects you may have when taking MOUNJARO. If you experience any side effects including side effects not listed here, tell your healthcare professional.

Belching

Bloating of the stomach

Constipation

Decreased appetite

Diarrhea

Feeling tired

Gas (flatulence)

Increased heart rate

Indigestion

Injection site reactions – such as bruising, pain, irritation, itching, and rash

Nausea

Reflux or heart burn – also called gastro-esophageal reflux disease

Stomach pain

Vomiting

Weight loss

If you have a troublesome symptom or side effect, including symptoms or side effects that are not listed here, or a side effect becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store MOUNJARO in a refrigerator at 2°C to 8°C.

If needed, each single-dose pen or single-dose vial can be stored at room temperature below 30°C for up to a total of 21 days.

Do not freeze MOUNJARO. Do not use MOUNJARO if frozen. If the pen or vial has been frozen, throw it away and use a new pen or vial.

Store MOUNJARO in the original carton to protect from light.

Keep out of reach and sight of children.

Throw away all opened vials after use, even if there is medicine left in the vial.

If you want more information about MOUNJARO:

Talk to your healthcare professional.

Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.

CONTRAVE ^®

naltrexone HCl—bupropion HCl

Antiobesity agent—Weight Management Bausch Health

Date of Revision: August 21, 2023

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

What is CONTRAVE used for?

CONTRAVE is used in adults together with a reduced-calorie diet and increased physical activity to manage weight in adults who are:

obese; or overweight and who have at least one weight-related problem, such as:

high blood pressure that is controlled by medicine, type 2 diabetes, or high levels of lipids in the blood (e.g., cholesterol or other types of fat).

It is not known if it is safe to take CONTRAVE with other weight loss products. Other products include prescription drugs, over the counter drugs, and natural health products. It is also not known if CONTRAVE changes your risk of heart or blood vessel problems (e.g., stroke) or of death due to heart or blood vessel problems.

CONTRAVE is not for use in patients younger than 18 years of age.

How does CONTRAVE work?

CONTRAVE contains two ingredients, naltrexone hydrochloride and bupropion hydrochloride. These medicines work on two separate areas of the brain to help control eating (appetite and cravings).

What are the ingredients in CONTRAVE?

Medicinal ingredients: Naltrexone Hydrochloride and Bupropion Hydrochloride.

Non-medicinal ingredients: Colloidal Silicon Dioxide, Crospovidone, Edetate Disodium, FD&C Blue No. 2 Indigo

Carmine Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Lactose Monohydrate, LCysteine Hydrochloride, Macrogol/Peg, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol-Part Hydrolyzed, Talc, and Titanium Dioxide.

CONTRAVE comes in the following dosage forms:

Extended-release tablets: 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride for each tablet. The tablets are blue, round, and have “NB-890” on one side.

Do not use CONTRAVE if:

you are allergic to naltrexone, bupropion, or any of the other ingredients in CONTRAVE. you have high blood pressure that cannot be controlled by medicine. you have severe liver problems.

you have end-stage kidney failure (kidney failure where the kidneys do not work enough to support the needs of your body). you have or had seizures.

you are taking thioridazine, an antipsychotic medicine that is typically used to treat schizophrenia and psychosis. An ingredient in CONTRAVE may cause the level of thioridazine in your blood to increase.

you are taking any other medicines which contain bupropion hydrochloride, such as WELLBUTRIN SR, WELLBUTRIN XL and ZYBAN. you have or had an eating disorder such as:

anorexia (eating very little), bulimia (eating too much and throwing up so you don’t gain weight).

you are dependent on opioid pain medicines or use medicines to help stop taking opioids (e.g., methadone or buprenorphine), or are in opioid withdrawal. you drink a lot of alcohol and abruptly stop drinking.

you take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden.

you are taking medicines called monoamine oxidase inhibitors (MAOIs).

Ask your healthcare professional if you are not sure if you take an MAOI.

Do not start CONTRAVE until you have stopped taking your MAOI for at least 14 days.

you are pregnant or planning to become pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CONTRAVE. Talk about any health conditions or problems you may have, including if you:

are at a higher risk of seizures. This includes if you:

have had a serious head injury.

have ever had any fits or seizures in the past, especially if you have ever had a seizure while taking

CONTRAVE, WELLBUTRIN SR, WELLBUTRIN XL, or ZYBAN;

have or have had a tumour or infection in your brain or spinal cord; have had a stroke (bleeding or blood clot in the brain); have blood vessel problems;

have low sodium or low sugar levels in your blood; have low oxygen levels in your body; have liver problems;

are addicted to cocaine or other drugs that stimulate your central nervous system; excessively take sedatives or have withdrawal symptoms from discontinuing sedatives; excessively drink alcohol;

have diabetes and take insulin or other medicines to control your blood sugar (e.g., sulfonylureas and meglitinides);

are taking medications that lower the seizure threshold (e.g., medicines used to treat depression and other mental health problems, theophylline, and systemic steroids).

have or had depression or other mental health problems.

have bipolar disorder or are at a higher risk for bipolar disorder (e.g., family history of bipolar disorder, suicidal thoughts or actions, or depression). have suicidal thoughts or actions or have attempted suicide in the past. have or had liver problems.

have high blood pressure that is controlled by medicine or have a higher risk of developing high blood pressure. have or had a heart attack.

have kidney problems. are over 65 years of age.

are lactose intolerant or have one of the following rare hereditary diseases:

Galactose intolerance

Lapp lactase deficiency

Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in CONTRAVE.

are dependent on alcohol or being treated for alcohol dependence. have significant weight loss.

have systemic lupus erythematosus (SLE), an autoimmune disease where your body’s immune system attacks your own tissues and organs.

have anatomically narrow angles (the space or angle between the cornea and iris is abnormally small).

have or have had a speech disorder where you stammer or stutter (dysphemia). Taking CONTRAVE may cause your speech disorder to come back or worsen.

Other warnings you should know about:

CONTRAVE can cause the following serious side effects:

   Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): One of the ingredients in CONTRAVE, bupropion, can cause an acute attack of glaucoma. Having your eyes checked before you take CONTRAVE could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical help if you experience:

eye pain

changes in vision

swelling or redness in or around the eye

Blood pressure and heart rate increases: You may be more at risk if you already have high blood pressure.

Brugada syndrome (serious heart problem): Bupropion, one of the ingredients in CONTRAVE, may reveal a hidden heart problem you did not know you had, a problem called Brugada syndrome. Brugada syndrome can be serious and cause sudden death. Get immediate medical help if you experience fainting, dizziness, heart palpitations or abnormal heartbeat while taking CONTRAVE.

Before you start taking CONTRAVE, tell your healthcare professional if you:

have Brugada syndrome.

have unexplained fainting, or a family history of Brugada syndrome or unexplained sudden death before 45 years of age. This could mean you may have Brugada syndrome.

Hallucinations, delusions, paranoia (seeing, sensing or believing things that are not there).

Hypoglycemia (low blood sugar): You may be more at risk of developing hypoglycemia if you have type 2 diabetes, and you lose weight while taking CONTRAVE. This applies only if you take medicines to treat type 2 diabetes such as insulin or sulphonylureas. You may need a change in your medicine used to treat your diabetes.

Liver problems: This includes hepatitis (inflammation of the liver) and liver dysfunction.

Seizures (fits): The risk of having a seizure while taking CONTRAVE is related to the dose. It is important that you take CONTRAVE exactly as your healthcare professional tells you to. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and get immediate medical help.

Your risk of seizures increases if you take CONTRAVE, especially:

if your dose of CONTRAVE increases; if you do not take CONTRAVE as directed; if you take CONTRAVE with high-fat meals; if you take certain medicines at the same time; if you are already at a higher than usual risk of seizures.

Serotonin toxicity (also known as serotonin syndrome): CONTRAVE can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. It is more likely to develop serotonin toxicity when you start taking CONTRAVE or when your dose is increased. It may also occur if you take CONTRAVE with certain antidepressants or migraine medications.

Serotonin toxicity symptoms include:

fever, sweating, shivering, diarrhea, nausea, vomiting;

muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination, flushing; fast heartbeat, changes in blood pressure;

confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, anxiety, and coma.

Severe allergic reaction:

CONTRAVE may cause an allergic reaction. Symptoms may include skin rash, hives, swelling of the face or throat, muscle pain, joint pain, difficulty breathing, severe skin reactions, chest pain or fever.

If you have an allergic reaction your symptoms may not go away even after you stop taking

CONTRAVE.

   Severe skin reactions: Taking CONTRAVE may cause serious skin reactions. This included StevensJohnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), and erythema multiforme. Stop taking CONTRAVE and get immediate medical help if you experience:

severe skin rash peeling of the skin

blisters around the mouth, eyes or genitals itching

chest pain swelling shortness of breath body aches fever

Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): CONTRAVE has been associated with new or worsening symptoms in patients susceptible to SLE and CLE. These are autoimmune diseases where your body’s immune system attacks your own tissues and organs. Talk to your healthcare professional right away if you have blotchy rashes mainly on the face, fatigue, joint pain, swelling in the joints, muscle pain, rash, swelling, fever, nausea, or loss of appetite.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Alcohol:

CONTRAVE lowers your alcohol tolerance. This means you may feel the effects of alcohol when taking less alcohol than usual. Drinking alcohol while taking CONTRAVE may increase your risk of having seizures and allergic reactions. It is best not to drink alcohol at all while taking CONTRAVE to avoid side effects.

Pregnancy and Breastfeeding:

Do not take CONTRAVE if you are pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE. They will discuss the risks of birth defects and complications after birth if you take CONTRAVE during pregnancy.

Talk to your healthcare professional if you are breastfeeding or thinking of breastfeeding. CONTRAVE passes into breastmilk. You should not breastfeed while you are taking CONTRAVE.

Opioid overdose:

If you take opioids while taking CONTRAVE, the ingredient naltrexone in CONTRAVE can increase your chance of having an opioid overdose. Examples of opioids or medicines that contain opioids include heroin, prescription pain medicines, and methadone.

You can accidentally overdose in two ways:

Naltrexone blocks the effects of opioids. Because of this, do not take large amounts of opioids to try to overcome the opioid-blocking effects of naltrexone. It can lead to serious injury, coma, or death.

After you take naltrexone, its blocking effect slowly decreases and goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with CONTRAVE can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:

after you have gone through detoxification when your next dose of CONTRAVE is due if you miss a dose of CONTRAVE after you stop CONTRAVE treatment

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Opioid withdrawal:

You should not use any type of opioid for at least 7 to 10 days before starting CONTRAVE. This includes street drugs, prescription pain medicines (including tramadol), cough, cold, diarrhea medicines that contain opioids, or opioid dependence treatments (e.g., buprenorphine or methadone). Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare professional if you are taking CONTRAVE before a medical procedure or surgery.

Testing and Check-Ups:

Your healthcare professional may perform certain tests (e.g., blood tests) to monitor:

your blood pressure and heart rate before and regularly during your treatment with CONTRAVE, especially if you have type 2 diabetes.

your blood sugar and red blood cell levels before and during your treatment with CONTRAVE, especially if you have type 2 diabetes.

any emotional and behavioural changes for the first few months after you start your treatment, and when your dose changes. This can include the feelings of depression, anxiety, agitation, irritability, behavioural changes, or suicidal thoughts and behaviour. if your kidneys are working properly. if your liver is working properly.

If you take a urine drug screening test, CONTRAVE may give a positive test result for amphetamines. Tell the laboratory technician that you are taking CONTRAVE. They can do a more specific drug screening test for you.

Driving and using machines:

CONTRAVE may impair your ability to do tasks requiring judgment, thinking or motor skills. You should not drive or use machines until you know how CONTRAVE affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with CONTRAVE:

alcohol. cimetidine, a medicine used to treat ulcers of the stomach and intestines. digoxin, a medicine used to treat various heart conditions. lithium, a medicine used to treat bipolar disorder. medicines used to help you to sleep (e.g., sedatives such as diazepam).

medicines used to lower your blood pressure (e.g., valsartan, clonidine, or beta blockers such as metoprolol).

medicines used to prevent epilepsy or seizures (e.g., carbamazepine, phenobarbital, phenytoin, or valproate).

medicines used to regulate your heart rhythm (e.g., propafenone or flecainide). medicines used to treat cancer (e.g., cyclophosphamide, ifosphamide, or tamoxifen).

medicines used to treat diabetes by helping to control sugar levels in the blood (e.g., metformin, insulin, sulphonylureas, glyburide, glibenclamide, nateglinide or repaglinide).

medicines used to treat depression and other mental health problems (e.g., citalopram, desipramine, venlafaxine, haloperidol, risperidone, selective serotonin reuptake inhibitors [SSRIs], imipramine, or paroxetine).

medicines used to treat hay fever, itch, swelling, and other allergic reactions (e.g., antihistamines or steroids). medicines used to treat heart disease or stroke (e.g., ticlopidine, digoxin, or clopidogrel). medicines used to treat HIV infection and AIDS (e.g., ritonavir, lopinavir, efavirenz, or orphenadrine). medicines used to treat infections (e.g., quinolones such as ciprofloxacin).

medicines used to treat Parkinson’s Disease (e.g., levodopa and amantadine). nifedipine, a medicine used to treat chest pain or high blood pressure.

opioids and medicines that contain opioids, used to treat:

cough and cold (e.g., mixtures containing dextromethorphan or codeine); opiate addiction (e.g., methadone); pain (e.g., morphine, codeine, or tramadol); diarrhea (e.g., loperamide).

theophylline, a medicine used to treat asthma and other lung diseases.

How to take CONTRAVE:

CONTRAVE must be taken with a reduced calorie-diet and increased physical activity.

Take CONTRAVE exactly as your healthcare professional tells you to.

Do not change your CONTRAVE dose without talking with your healthcare professional They will change your dose if needed. Your risk of seizures may increase if you take more CONTRAVE than your healthcare professional tells you to.

If you have not lost a certain amount of weight after 16 weeks of treatment, your healthcare professional may tell you to stop taking CONTRAVE.

CONTRAVE must be taken orally by mouth. Swallow CONTRAVE tablets whole. Do not cut, chew, or crush the tablets. Tell your healthcare professional if you cannot swallow CONTRAVE tablets whole.

Take each dose of CONTRAVE with food. Do not take CONTRAVE with high-fat meals as it may increase your risk of seizures.

Do not drink a lot of alcohol while taking CONTRAVE. Talk with your healthcare professional if you drink a lot of alcohol. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.

Usual dose:

Your healthcare professional will determine the right dose for you based on your health, your condition, and how you react to CONTRAVE. Your dose may be increased by your healthcare professional based on a weekly schedule. Never take more than you are prescribed per day.

The table below explains how the usual adult dose of CONTRAVE will be slowly increased over the first 4 weeks:

The maximum dose for CONTRAVE should not be exceed:

Do not take more than 2 tablets at the same time; and

Do not take more than 4 tablets in one day (e.g., 2 tablets in the morning and 2 tablets in the evening).

Overdose:

If you take too many CONTRAVE tablets, you may increase your risk of having serious and life-threatening effects, including:

seizures,

hallucinations (seeing or believing thing that are not there), loss of consciousness or coma, irregular heartbeat, fever,

muscle rigidity or muscle breakdown, low blood pressure, stupor,

difficulty breathing, heart problems,

serotonin toxicity (also known as serotonin syndrome), which is a serious condition that can be lifethreatening. See the Serious side effects and what to do about them table for more details.

If you think you, or a person you are caring for, have taken too much CONTRAVE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of CONTRAVE, do not take the missed dose. Instead, take the next dose at the usual scheduled time. Do not double the dose to make up for the missed dose.

What are possible side effects from using CONTRAVE?

These are not all the possible side effects you may feel when taking CONTRAVE. If you experience any side effects not listed here, tell your healthcare professional.

The common side effects of CONTRAVE include:

nausea; constipation; diarrhea; dizziness;

feeling off balance or like everything is spinning (vertigo); dry mouth; headache or migraine;

trouble sleeping; vomiting; abdominal pain; upset stomach; shaking (tremor);

foul, salty, rancid or metallic taste in the mouth; sleepiness, feeling tired, lack of energy; trouble paying attention; abnormal dreams;

flu;

excessive sweating more than usual; itching; rash; hair loss; ringing in the ear; blurred vision.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store CONTRAVE at room temperature between 15°C to 25°C.

Keep container tightly closed.

If your healthcare professional tells you to stop taking CONTRAVE, return any leftover medicine to your pharmacist.

Keep out of reach and sight of children.

If you want more information about CONTRAVE:

Talk to your healthcare professional.

Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.

This leaflet was prepared by:

Bausch Health, Canada Inc.

2150 St-Elzear Blvd., West

Laval, QC, H7L 4A8 www.bauschhealth.ca

This Information for the Patient handout was developed by the pharmaceutical manufacturer in accordance with the requirements of Health Canada. CPhA assumes no responsibility for or liability in connection with the use of this handout. Once printed there is no guarantee the information is up-todate. [Printed on: 09-18-2024 11:54 AM]

CPS, Patient Medication Information © Canadian Pharmacists Association, 2024. All rights reserved

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION 

^PrWegovy^®

semaglutide injection

Read this carefully before you start taking Wegovy^® and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Wegovy^®.  

Serious Warnings and Precautions

Possible Risk of thyroid tumours, including cancer

As part of drug testing, semaglutide, the active ingredient in Wegovy^® was given to rats and mice in long term studies. In these studies, semaglutide caused both rats and mice to develop medullary thyroid tumours, some of which were cancer. It is not known if semaglutide will cause thyroid tumours or a rare type of thyroid cancer called medullary thyroid cancer in people. Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

While taking Wegovy^®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. These may be symptoms of thyroid cancer. You should discuss any safety concerns you have about the use of Wegovy^® with your doctor. 

What is Wegovy^® used for?

Wegovy^® is used for chronic weight management in addition to reduced calorie diet and increased physical activity in adults, who have:

• a BMI of 30 kg/m² or greater (with obesity), or
• a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems.

*BMI (Body Mass Index) is a measure of your weight in relation to your height. See your doctor to have your BMI measured.

Wegovy^® is used for chronic weight management in addition to a reduced calorie diet and increased physical activity in adolescents aged 12 to less than 18 years, who have obesity, as diagnosed by a doctor, and who have not succeeded in weight loss with diet and exercise alone.

How does Wegovy^® work?

Wegovy^® is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Wegovy^® works by causing you to feel fuller and less hungry Wegovy^® should be used along with a reduced calorie diet and increased physical activity.

What are the ingredients in Wegovy^®? Medicinal ingredients: semaglutide 

Wegovy™ (semaglutide injection) Product Monograph

Single-Use Pen

Non-medicinal ingredients: Disodium phosphate dihydrate; Hydrochloric acid; Sodium Chloride; Sodium hydroxide; Water for injection

Multi-Use pen

Non-medicinal ingredients: Disodium phosphate dihydrate; Propylene glycol; Phenol; Hydrochloric acid; Sodium hydroxide; Water for injection

Wegovy^® comes in the following dosage forms:

Wegovy^® is supplied as a clear and colourless solution for injection in a pre-filled pen.

Wegovy^® is available in a carton of 4 single-use, disposable, pre-filled pens delivering doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg. The 0.25 mg, 0.5 mg and 1 mg pens contain 0.5 mL solution. The 1.7 mg and 2.4 mg pens contain 0.75 mL of solution.

Wegovy^® is available in a carton of 1 multi-use, disposable, pre-filled pen delivering doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg. The 0.25 mg and 0.5 mg pens contain 1.5 mL solution. The 1 mg,1.7 mg and 2.4 mg pens contain 3 mL of solution.

Your single-use pen is only to be used once. It comes with:

• One pre-set dose.
• A needle cover that hides the built-in needle before, during and after use.
• Automatic dosing that starts when the needle cover is pressed against your skin as described by your healthcare professional. 

Your multi-use pen can be used multiple times. It comes with:

• Four doses of either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.
• 4 disposable needles

Do not use Wegovy^® if:

• You are allergic to semaglutide or any of the other ingredients of this medicine.
• You or a member of your family has ever had medullary thyroid cancer (MTC).
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You are pregnant or breastfeeding.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Wegovy^®. Talk about any health conditions or problems you may have, including if you: 

• or a member of your family has or has had medullary thyroid carcinoma (MTC), or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have type 1 diabetes.
• Have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
• Have ever had an allergic reaction to OZEMPIC^® or RYBELSUS^®.
• Have a high heart rate (fast pulse).
• Have ever had an inflamed pancreas (pancreatitis).
• Are breastfeeding or plan to breastfeed.
• Are pregnant or plan to become pregnant.
• Have end stage renal disease.
• Have gastrointestinal (digestive) problems, including severe vomiting, diarrhea and/or dehydration.
• Have hepatic (liver) disease.
• Have diabetic eye disease (diabetic retinopathy).
• Have heart failure.
• Have ever had gallbladder disease.
• Have ever attempted suicide, or had suicidal thoughts or depression.

Other warnings you should know about:

Children and adolescents

Wegovy^® is not recommended in children and adolescents under 12 years of age or less than 60 kg (132 lbs) as the safety and efficacy in this age and weight group have not yet been studied.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Wegovy^® should not be used during pregnancy and for at least two months before a planned pregnancy because it is not known if it may affect your unborn child.

If you could become pregnant while using Wegovy^®, it is recommended to use contraception.

Do not use this medicine if you are breast-feeding. This is because it is not known if Wegovy^® passes into breast milk.

Driving and using machines

If you use this medicine in combination with certain diabetes medications (e.g. sulfonylurea or insulin), low blood sugar may occur which may reduce your ability to concentrate or make you feel dizzy. Avoid driving or using machines if you feel dizzy or unable to concentrate. Talk to your doctor for further information.

Severe and on-going stomach pain which could be due to inflammation of the pancreas If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas).

Effects on the digestive system and dehydration

During treatment with Wegovy^®, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhea. These side effects can cause dehydration (loss of fluids). It is therefore important to drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Diabetic eye disease (retinopathy)

This medication may cause a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye or vision problems while taking this medication, talk to your doctor.

Low blood sugar (hypoglycemia)

If you are taking certain diabetes medication (e.g. sulfonuylurea or insulin) when you start taking Wegovy^®, this could result in low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of your diabetes medication needs to be changed.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

People with Diabetes

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:

• sulfonylurea
• insulin

Do not use Wegovy^® as a substitute for insulin.

The following may interact with Wegovy^®:

The following list includes some, but not all, of the drugs that may increase your heart rate. You should check with your doctor or pharmacist before taking any other medication with Wegovy^®:

• Drugs to treat hypertension.
• Drugs to treat heart failure.
• Drugs to treat HIV infection.
• Drugs to treat attention deficit-hyperactivity disorder.
• Drugs to suppress appetite/cause weight loss.
• Drugs to treat asthma.

How to take Wegovy^®

Wegovy^® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.

Before you use the pen for the first time, your healthcare professional will show you how to use it.

Detailed instructions for use are on the other side of this leaflet.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

You should use Wegovy^® once a week on the same day each week if possible. You can give yourself the injection at any time of the day – regardless of meals. To help you remember to inject Wegovy^® once a week only, it is recommended to note the chosen day of the week (e.g. Wednesday) on the carton.

If necessary, you can change the day of your weekly injection of Wegovy^® as long as it has been at least 3 days since your last injection of Wegovy^®.

Your doctor should start you on a reduced calorie meal plan and physical activity program when you start taking Wegovy^®. Stay on this program while you are taking Wegovy^®.

Usual dose:

Adults

The recommended dose is 2.4 mg once weekly.

Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment.

• When you first start taking Wegovy^®, the starting dose is 0.25 mg once weekly
• Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once weekly.

You will be told to follow the table below.

• Once you reach the recommended dose 2.4 mg, keep using this dose. Do not increase your dose further.

Your doctor will assess your treatment on a regular basis and may tell you to change your dose if necessary.

Do not stop using this medicine without talking to your doctor.

Adolescents

For adolescents aged 12 to less than 18 years, the same dose escalation schedule as for adults should be applied (see above). Adolescents should aim at reaching the 2.4 mg maintenance dose, but can stay at a lower dose if the 2.4 mg dose cannot be reached or is not tolerated.

Overdose:

If you use more Wegovy^® than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea) or being sick (vomiting), or diarrhea, or hypoglycemia (dizziness, confusion, passing out).

If you think you have taken too much Wegovy^®, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forgot to inject a dose and:

• It is 5 days or less since you should have used Wegovy^®, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
• It is more than 5 days since you should have used Wegovy^®, skip the missed dose. Then inject your next dose as usual on your scheduled day.

Do not take a double dose to make up for a missed dose.

What are possible side effects from using Wegovy^®?

These are not all the possible side effects you may feel when taking Wegovy^®. If you experience any side effects not listed here, contact your healthcare professional.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• feeling or being sick (nausea or vomiting)
• diarrhea
• constipation
• stomach pain
• feeling weak or tired
• headache

–     these usually goes away over time

Common: may affect up to 1 in 10 people

• feeling dizzy
• upset stomach or indigestion
• burping
• gas (flatulence)
• bloating of the stomach
• inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
• reflux or heartburn – also called ‘gastro-esophageal reflux disease’
• hair loss
• injection site reactions
• low blood sugar (hypoglycaemia) in patients with diabetes
• low blood pressure
• increase of pancreatic enzymes (such as lipase) shown in blood tests
• hemorrhoids
• change in the way food or drink tastes

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon: may affect up to 1 in 100 people

• fast heartbeat
• increase of pancreatic enzymes (such as amylase) shown in blood tests
• feeling faint or fainting/passing out
• low blood sugar (hypoglycemia) in patients without diabetes

Unknown:

• ileus (a severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc)
• bowel obstruction
• a delay in the emptying of the stomach

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Storage:

Keep out of reach and sight of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ʻEXP’. The expiry date refers to the last day of that month.

Keep away from the cooling element of the refrigerator. Do not freeze Wegovy^® and do not use Wegovy^® if it has been frozen. Protect from excessive heat and light.

Wegovy^® pen is for use by one person only.

Wegovy^® should not be used if it does not appear clear and colourless.

Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Single-Use Pen

Store the Wegovy^® single-use pen in the refrigerator at 2°C to 8°C. If needed, each single-use pen, prior to cap removal, can be kept at a temperature below 30°C for a total of 28 days.

If your pen has been exposed to light or temperatures above 30°C, has been out of the refrigerator for more than 28 days, or has been frozen, dispose of it.

Storage of Wegovy^® single-use pen in the original carton is recommended until time of administration in order to protect from light.

Safely discard the Wegovy^® single-use pen into a sharps disposal container after use. Do not dispose of the pen in your household trash.

Multi-Use Pen

When you are not using the pen, keep the pen cap on in order to protect from light.

Before Opening:

Store in a refrigerator (2°C – 8°C).

During Use:

You can keep the pen for 8 weeks when stored at a temperature below 30°C or in a refrigerator (2°C – 8°C).

If your pen has been exposed to temperatures above 30°C, has been out of the refrigerator for more than 8 weeks, or has been frozen, dispose of it.

Always remove the injection needle after each injection and store the pen without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

If you want more information about Wegovy^®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website(http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.novonordisk.ca, or by calling 1-800-465-4334.

This leaflet was prepared by Novo Nordisk Canada Inc.

Last Revised 2024

Wegovy^®, NovoFine^®, NovoFine^® Plus and Novo Nordisk are trademarks of Novo Nordisk A/S and used under license by Novo Nordisk Canada Inc.

© 2024

Novo Nordisk Canada Inc.

What it does:

DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPOTESTOSTERONE helps raise your testosterone to normal levels.

When it should not be used:

• if you have prostate or breast cancer (confirmed or suspected by your doctor)
• if you have difficulty in urinating due to an enlarged prostate
• if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE, including testosterone USP that is chemically synthesized from soy (see “What the medicinal and nonmedicinal ingredients are” in this section).

DEPO-TESTOSTERONE should NOT be used by women. Pregnant and breast-feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

DEPO-TESTOSTERONE is available in one strength, 100 mg

testosterone cypionate /mL.

DEPO-TESTOSTERONE is available in the following packaging:

100 mg per mL – In vials of 10 mL.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.

DEPO-TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome” (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.

Pregnancy: Benzyl alcohol can cross the placenta.

Before using DEPO-TESTOSTERONE, talk to your doctor if

you:

• have difficulty urinating due to an enlarged prostate.

Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;

• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea);
• have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.

Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that include:

• Insulin
• Corticosteroids
• Propranolol
• Warfarin

PROPER USE OF THIS MEDICATION

DEPO-TESTOSTERONE should only be administered by a health care professional.

When you are given DEPO-TESTOSTERONE, your blood testosterone should be checked on a regular basis.

Usual dose: 200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:

• skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count, (hematocrit and

hemoglobin);

• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or

the legs;

This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE 1% GEL

What it does:

TESTOSTERONE 1% GEL delivers medicine into your bloodstream through your skin. TESTOSTERONE 1% GEL helps raise your testosterone to normal levels.

When it should not be used:

• If you have or it is suspected that you have prostate or breast cancer.
• If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are” in this section)].

TESTOSTERONE 1% GEL should NOT be used by women. Pregnant and breast-feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and/or with clothing or other fabrics exposed to TESTOSTERONE 1% GEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate.

What dosage forms it comes in:

TESTOSTERONE 1% GEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

• One 2.5 g packet contains 25 mg of testosterone
• One 5.0 g packet contains 50 mg of testosterone
• One full press of the pump delivers 1.25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

TESTOSTERONE 1% GEL can be transferred to another person when skin-to-skin contact with application site occurs.

• Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
• Keep children away from unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and from unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL.
• Men who use TESTOSTERONE 1% GEL must strictly follow the instructions for use to lower the risk of transferring TESTOSTERONE 1% GEL to another person.

You should prevent TESTOSTERONE 1% GEL from transferring to another person, especially pregnant or breast-feeding women, or children by taking the following precautions:

• Children and women should avoid contact with the application sites on men using TESTOSTERONE 1% GEL.
• TESTOSTERONE 1% GEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
• Wash hands immediately with soap and water after application of TESTOSTERONE 1% GEL.
• Cover the application site(s) with clothing (such as a shirt) after TESTOSTERONE 1% GEL has dried.
• If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any TESTOSTERONE 1% GEL left on the application site(s).
• In the event that an unwashed or uncovered TESTOSTERONE 1% GEL application site and/or unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour. In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits. Any of these changes should be brought immediately to the attention of a doctor. The possibility of exposure to testosterone should be discussed with the doctor.

TESTOSTERONE 1% GEL must not be used by children under the age of 18.

If you are suffering from severe heart, liver or kidney disease, treatment with testosterone may cause serious complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (inadequate pumping of the heart with build-up of fluid in body tissues).

Testosterone may cause a rise in blood pressure. Therefore, TESTOSTERONE 1% GEL should be used with caution if you are suffering from high blood pressure.

In patients receiving long-term TESTOSTERONE 1% GEL therapy, the physician may prescribe regular blood tests, such as testosterone, complete blood count, liver function tests and lipid profile. Testosterone increases red blood cell count which theoretically could increase the risk of blood clots.

Your physician may also monitor your prostate gland for any negative effects of testosterone therapy by performing digital rectal examinations.

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Before using TESTOSTERONE 1% GEL, talk to your doctor if you:

• have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea).
• have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.

Drug Abuse and Dependence:

TESTOSTERONE 1% GEL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Reduction in testicular size (testicular atrophy), limited or complete infertility have been reported in men who abuse anabolic androgenic steroids.

Precautions while using TESTOSTERONE 1% GEL:

Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.

INTERACTIONS WITH THIS MEDICATION:

Be sure to tell your doctor about all other prescription and non-prescription medicines you are taking, if any. Drugs that may interact with TESTOSTERONE 1% GEL include:

• insulin
• corticosteroids
• propranolol
• anti-clotting medications (e.g., warfarin)

PROPER USE OF THIS MEDICATION:

1. Apply TESTOSTERONE 1% GEL at the same time each day, (preferably in the morning). Apply the proper amount of gel every morning as instructed by your doctor. The amount of testosterone you need may be adjusted by your doctor. Always follow your doctor’s recommendations.
2. Be sure your skin is completely dry before applying TESTOSTERONE 1% GEL. For example, if you take a bath or shower in the morning, apply TESTOSTERONE 1% GEL after your bath or shower once your skin is completely dry.
3. Apply TESTOSTERONE 1% GEL only to your abdomen (stomach area), shoulders, and/or upper arms, as shown in the following diagram.

o Use a circular motion to rub in the gel for several seconds. Applying TESTOSTERONE 1% GEL only to the areas shown helps ensure that your body will absorb the right amount of testosterone. TESTOSTERONE 1% GEL may be applied to the same areas of the body each day. It is not necessary to alternate application sites.

o Never apply TESTOSTERONE 1% GEL to your genitals (penis and scrotum) or to damaged skin.

o Apply TESTOSTERONE 1% GEL only to healthy, normal skin. Avoid skin with open sores, wounds, sunburn, or irritation.

4. Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.
5. Wash your hands immediately following application.

o It is important to wash your hands with soap and water right away to reduce the chance that any TESTOSTERONE 1% GEL will spread from your hands to other people.

o If, however, you expect direct skin contact with someone else, you should wash your application site(s) with soap and water before that encounter. This will reduce the chance that any TESTOSTERONE 1% GEL will transfer to the other person.

6. Let TESTOSTERONE 1% GEL dry for a few minutes before you dress.

o This prevents your clothing from absorbing or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.

o Wait 5 to 6 hours before showering or swimming. To ensure that TESTOSTERONE 1% GEL is fully absorbed into your system, you should generally wait five to six hours after application before showering or swimming. However, once in a while you may shower or swim as soon as one hour after applying TESTOSTERONE 1% GEL. Although this is not recommended, if done infrequently, it will have little effect on the overall amount of TESTOSTERONE 1% GEL that is absorbed by your body.

o Transference of TESTOSTERONE 1% GEL to another person can be completely prevented when the application site is covered with a long-sleeved shirt (cotton-polyester blend).

7. It is important that you read and follow the directions below on how to use TESTOSTERONE 1% GEL properly:

Using the TESTOSTERONE 1% GEL packet:

1. Opening the packet:

Open one TESTOSTERONE 1% GEL aluminum foil packet by folding it along the top edge and carefully tearing it open.

1. Applying TESTOSTERONE 1% GEL to your skin:

o Gently squeeze the gel from the bottom of the packet toward the top.

o Squeeze out half (1/2) of the contents of the packet and apply it to the areas of your body shown in the diagram. Use a circular motion to rub in the gel for several seconds. Once you have applied this first half to your skin, squeeze out the second half and apply it in the same manner. Discard the empty packet in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

What should I do if I get TESTOSTERONE 1% GEL in my eyes?

If you get TESTOSTERONE 1% GEL in your eyes, rinse your eyes right away with warm clean water to flush out any TESTOSTERONE 1% GEL. Seek medical attention if discomfort persists.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. If your next dose is less than 12 hours away, it is best to wait. Do not take the skipped dose. If it is more than 12 hours until your next dose, take the dose that you missed. Resume your normal dosing the next day.

Overdose:

Contact your doctor or pharmacist or poison control centre immediately if you suspect an overdose.

If you use more TESTOSTERONE 1% GEL than the recommended dose (an overdose), wash the skin with soap and water where TESTOSTERONE 1% GEL was applied and contact your doctor or pharmacist .

What to do if someone is exposed to the medication:

If someone else is exposed to TESTOSTERONE 1% GEL either by direct contact with the gel itself or indirectly because of contact with your treated skin, that person should wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some testosterone.

This is particularly important for women, especially pregnant or nursing women, and children. Children have naturally low levels of testosterone and could be harmed by higher levels. Pregnant women are at an even higher risk because increased testosterone levels may cause harm or abnormalities in the unborn baby.

Never share your TESTOSTERONE 1% GEL with anyone.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medicines, TESTOSTERONE 1% GEL can have side effects. The following side effects have been reported for products containing testosterone:

• Skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count (hematocrit and hemoglobin);
• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or the legs.
• reduction in testicular size (testicular atrophy), limited or complete infertility

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. See WARNINGS AND PRECAUTIONS.

Changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits in the female partner or in any person (including children) exposed to skin-to- skin contact, should be brought to the attention of a doctor.

– hCG improve testosterone deficiency

hCG are also sometimes used as an alternative to testosterone products in men with testosterone deficiency.​

Testosterone along with hCG may help improve symptoms of testosterone deficiency while preventing some of testosterone’s side effects such as shrinking the gonads, altering sexual function and causing infertility.​

– It improve sexual function

hCG may also improve sexual function as an androgen, either alone or in combination with a standard testosterone ester​

– hCG can reverse steroid side effects

hCG helps to prevent or reverse some of the side effects steroids cause, such as gonad shrinkage and infertility.​

This leaflet is part III of a three-part “Prescribing Information” and is designed specifically for Consumers. 

This leaflet is a summary and will not tell you everything about  Testosterone Enanthate Injection, USP. Contact your doctor or  pharmacist if you have any questions about the drug. 

ABOUT THIS MEDICATION 

What the medication is used for: 

Your doctor has prescribed this medicine because your body is not making enough testosterone. The medical term for this condition is hypogonadism. 

What it does: 

Testosterone Enanthate Injection, USP delivers medicine into your bloodstream by intramuscular injection. Testosterone Enanthate  Injection, USP helps raise your testosterone to normal levels. 

When it should not be used:

• If you have or it is suspected that you have prostate or breast cancer. 
• If you have difficulty in urinating due to an enlarged  prostate.  
• If you have known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the nonmedicinal ingredients are” in  this section)] 

Testosterone Enanthate Injection, USP should NOT be used by  women. Pregnant and breast feeding women are especially at risk.  Testosterone may cause harm to your unborn baby. 

What the medicinal ingredient is: 

testosterone enanthate 

What the nonmedicinal ingredients are: 

sesame oil  

chlorobutanol 

What dosage formsit comes in: 

A 200 mg/mL solution for intramuscular injection. 

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone  in the older male (>65 years of age) to support safe use for a long  period of time. 

Testosterone Enanthate Injection, USP is not recommended for use in children < 18 years of age. 

You should not use testosterone in an attempt to reduce weight  

Before using Testosterone Enanthate Injection, USP, talk to your doctor if you: 

• have difficulty urinating due to an enlarged prostate. Older  patients may have a higher risk of developing an enlarged  prostate or prostate cancer; 
• have prostate cancer (confirmed or suspected); 
• have heart or blood vessel problems or a history of these  problems such as heart attacks, stroke, or blood clot in the  lungs or legs; 
• have liver or kidney; 
• have high blood pressure (hypertension); have diabetes; • have breathing problems during sleep (sleep apnea). 

Drug Abuse and Dependence: 

Testosterone Enanthate Injection, USP contains testosterone, which is a controlled substance under Schedule G of the Food and  Drugs Act. 

INTERACTIONS WITH THIS MEDICATION 

Tell your doctor or pharmacist if you are taking or have recently  taken any other drugs or herbal products, even those without a  prescription. 

Drugsthat may interact with Testosterone Enanthate Injection, USP include: 

• Insulin  
• Corticosteroids  
• Propranolol  
• Warfarin 

PROPER USE OF THIS MEDICATION Usual Dose: 

The usual dose is 100-400 mg every four weeks. 

What should I do if I miss a dose of Testosterone Enanthate  Injection, USP? If you missed a dose, you should consult your  health care provider (physician). 

What should I do in case of overdose? 

If you think you, or a person you are caring for, have taken too  much Testosterone Enanthate Injection, USP, contact a  healthcare professional, hospital emergency department, or  regional poison control centre immediately, even if there are no  symptoms. 

Testosterone Enanthate Injection

IMPORTANT: PLEASE READ 

Never share your Testosterone Enanthate Injection, USP with anyone. 

Every patient is different. Your doctor has prescribed  Testosterone Enanthate Injection, USP specifically for your  needs. To get the best results from Testosterone Enanthate  Injection, USP, it is essential that you take it exactly as your  doctor has prescribed. 

Use Testosterone Enanthate Injection, USP only for the  condition for which it was prescribed. If you have any  questions or concerns about Testosterone Enanthate  Injection, USP treatment, ask your health care provider or  pharmacist. They can answer your questions and may be  able to give you additional printed information about  Testosterone Enanthate Injection, USP. 

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Testosterone Enanthate Injection, USP can have  side effects. The following side effects have been reported for products containing testosterone: 

• increased or irregular heart rate, blood clot in the lungs or legs;  
• skin irritation or redness or rash at the application site;  • increased prostatic specific antigen (PSA); 
• enlarged prostate (benign prostatic hyperplasia);  • an increase in red blood cell count (hematocrit and  hemoglobin); 
• acne; 
• change in mood, depression; prolonged or painful erection; • sleep disturbances caused by breathing problems;  • aggression or aggressive behaviour; 
• breast enlargement and breast pain;  
• loss of hair and baldness; 
• high blood pressure;  
• weight gain;  
• headache, 
• dizziness. 

This is not a complete list of side effects. For any unexpected  effects while taking Testosterone Enanthate Injection, USP, contact your doctor or pharmacist. 

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND  WHAT TO DO ABOUT THEM 

Testosterone Enanthate Injection

HOW TO STORE IT 

IMPORTANT: PLEASE READ 

Testosterone Enanthate Injection, USP should be stored at controlled room temperature between 15°C and 30°C. 

Keep out of reach of children and pets. 

Reporting Side Effects 

You can report any suspected side effects associated with  the use of health products to Health Canada by: 

• Visiting the Web page on Adverse Reaction  Reporting (https://www.canada.ca/en/health 

canada/services/drugs-health 

products/medeffect-canada/adverse-reaction 

reporting.html ) for information on how to 

report online, by mail or by fax;or  

• Calling toll-free at1-866-234-2345. 

NOTE: Contact your health professional if you need  information about how to manage your side effects. The  Canada Vigilance Program does not provide medical advice. 

MORE INFORMATION If you want more information about Testosterone  Enanthate Injection, USP: 

• Talk to your healthcare professional 
• Find the full product monograph that is  

prepared for healthcare professionals and  

includes this Patient Medication Information  

by visiting the Health Canada website:  

(https://www.canada.ca/en/health 

canada/services/drugs-health-products/drug 

products/drug-product-database.html the  

manufacturer’s website  

https://www.hikma.com, or by calling 1-800- 

656-0793. 

This leaflet was prepared by Hikma Canada Limited,  5995 Avebury Road, Suite 804, Mississauga, ON L5R 3P9. Importer / Distributor: Innomar Strategies Inc., 8030  Esquesing Line, Milton, ON L9T 6W3.  

Last revised: March 17, 2023.

PrOMNITROPE® 

AWM nee trope 

(Somatropin for Injection) 

Lyophilized powder: 5.8 mg/vial 

Read this carefully before you start taking Omnitrope and each time you get a refill. This leaflet is a  summary and will not tell you everything about this drug. Talk to your healthcare professional about  your medical condition and treatment and ask if there is any new information about Omnitrope.  

Omnitrope is a biosimilar biologic drug (biosimilar) to the reference biologic drug Genotropin®. A  biosimilar is authorized based on its similarity to a reference biologic drug that was already authorized  for sale. 

What is Omnitrope used for? 

In children, Omnitrope is used to treat the following growth problems: 

∙ If you are not growing properly and you do not have enough of your own growth hormone. 

∙ If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect  growth – your doctor will have told you if you have this. 

∙ If you were small or too light at birth. Growth hormone may help you grow taller if you have  not been able to catch up or maintain normal growth by two years of age or later. 

∙ If you have idiopathic (unknown cause) short stature. 

In adults, Omnitrope is used to treat persons with pronounced growth hormone deficiency. This can  start during adult life, or it can continue from childhood. 

If you have been treatedwith Omnitrope for growth hormone deficiency during childhood, your  growth hormone status will be retested after completion of growth. If severe growth hormone  deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. 

How does Omnitrope work? 

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same  structure as natural human growth hormone which is needed for bones and muscles to grow. It also 

OMNITROPE (somatropin for injection) 

helps your fat and muscle tissues to develop in the right amounts. Recombinant means it is made using bacteria instead of being taken out of human or animal tissue. 

What are the ingredients in Omnitrope? 

Medicinal ingredient: Somatropin (recombinant human growth hormone) 

Non-medicinal ingredients:  

Omnitrope Lyophilized Powder: Glycine, disodium hydrogen phosphate, sodium dihydrogen  phosphate. 

Diluent Cartridge: Bacteriostatic Water for Injection USP (benzyl alcohol preserved) 

Omnitrope comes in the following dosage forms: 

Omnitrope (somatropin for injection) is supplied as follows: Lyophilized powder: 5.8 mg/vial. 

Do not use Omnitrope if: 

∙ You are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope. ∙ You have an active tumour. Tumours must be inactive and you must have finished your anti tumour treatment before you start using Omnitrope. 

∙ You are seriously ill (for example, complications following open heart surgery, abdominal  surgery, acute respiratory failure, accidental trauma or similar conditions). If you are about to  have, or have had, a major operation, or go into hospital for any reason, tell your doctor and  remind the other doctors you are seeing that you use growth hormone. 

∙ Omnitrope has been prescribed to stimulate growth but you have already stopped growing  (the growth plates on your long bones are closed). 

∙ In patients with diabetic retinopathy, a complication of diabetes that results from damage to  the blood vessels of the light-sensitive tissue at the back of the eye (retina). 

∙ If you or your child are allergic to benzyl alcohol. 

∙ You have uncontrolled diabetes or active psychosis. 

To help avoid side effects and ensure proper use, talk to your healthcare professional before you  take Omnitrope. Talk about any health conditions or problems you may have. 

Omnitrope therapy should be carried out under the regular guidance of a doctor who is experienced in  the diagnosis and management of patients with growth hormone deficiency. 

BEFORE you use Omnitrope talk to your doctor or pharmacist:  

∙ If the patient is at risk of developing diabetes, the doctor will need to monitor their blood sugar  level during treatment with Omnitrope. 

∙ If the patient has diabetes, they should closely monitor their blood sugar level during  treatment with Omnitrope and discuss the results with their doctor to determine whether they  need to change the dose of their medicines to treat diabetes. 

∙ If the patient is receiving treatment with thyroid hormones it may be necessary to adjust their  thyroid hormone dose.

OMNITROPE (somatropin for injection) 

∙ If the patient is taking growth hormone to stimulate growth and walk with a limp or if they  start to limp during their growth hormone treatment due to pain in their hip, they should  inform their doctor. 

∙ If the patient develops a strong headache, visual disturbances or vomiting they should inform  their doctor about it. 

∙ If the patient is receiving Omnitrope for growth hormone deficiency following a previous  tumour, they should be examined regularly for recurrence of the tumour. 

∙ If the patient is a survivor of childhood cancer. 

∙ If the patient, especially a child, develops severe abdominal pain (inflammation of the  pancreas). 

∙ If the patient is, or plans to become pregnant or is breastfeeding. 

∙ If the patient develop a limp while being treated with Omnitrope. 

∙ If the patient has Turner syndrome and develops an ear infection or headaches her doctor  should be told about these problems. 

∙ If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the  doctor should monitor the hormone replacement therapy closely during Omnitrope treatment. ∙ If you or your child are allergic to benzyl alcohol. Omnitrope 5.8 mg/vial Lyophilized Powder  requires reconstitution with a diluent that contains benzyl alcohol. 

After starting Omnitrope treatment some patients may need to start thyroid hormone replacement. 

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid  growth. 

The patient should not use Omnitrope if they are pregnant or are trying to become pregnant. 

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,  minerals, natural supplements or alternative medicines. 

The following may interact with Omnitrope: 

You should tell your doctor if you are using: 

∙ medicines to treat diabetes, 

∙ thyroid hormones, 

∙ synthetic adrenal hormones (corticosteroids), 

∙ sex hormones (for example oral estrogens), 

∙ cyclosporine (a medicine that weakens the immune system after transplantation), ∙ medicines to control epilepsy (anticonvulsants). 

Your doctor may need to adjust the dose of these medicines or the dose of Omnitrope. 

How to take Omnitrope: 

Recommended dosage 

The dose depends on your size, the condition for which you are being treated and how well growth  hormone works for you. Everyone is different. Your doctor will advise you about your individualized  dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg), as well as your  treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.

OMNITROPE (somatropin for injection)

Children with growth hormone deficiency: 

0.16-0.24 mg/kg body weight per week. Higher doses can be used. When growth hormone deficiency  continues into adolescence, Omnitrope should be continued until completion of physical development. 

Children with Turner syndrome: 

0.33 mg/kg body weight per week. 

Children with idiopathic short stature: 

UP TO 0.47 mg/kg body weight per week 

Children born smaller or lighter than expected and with growth disturbance: 

UP TO 0.48 mg/kg body weight per week. Your doctor will determine the most appropriate dose and  length of treatment. Treatment should be discontinued if: i) after the first year if you are not  responding or ii) if you have reached your final height and stopped growing. 

Adults with growth hormone deficiency: 

You should start with 0.15-0.3 mg per day. 

This dosage should be gradually increased or decreased according to blood test results as well as  clinical response and side effects.  

Follow the instructions given to you by your doctor 

Injecting Omnitrope 

Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection  needle into the fatty tissue just under your skin. Your doctor should have already shown you how to  use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. You should check with  your doctor or pharmacist if you are not sure. 

If you use more Omnitrope than you should 

If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your  blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not  yourself”, and you might faint. 

If you forget to use Omnitrope 

Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone  regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a  note of any missed injections and tell your doctor at your next check-up. 

If you stop using Omnitrope 

Ask for advice from your doctor before you stop using Omnitrope.  

If you have any further questions on the use of this product, ask your doctor or pharmacist. Overdose:

OMNITROPE (somatropin for injection)

Missed Dose: 

Missing injections can interfere with the effectiveness of the medication. Talk to your doctor if this  should happen. Do not try to make up for missed injections by “doubling up” on injections. 

Note: Do not reconstitute Omnitrope or inject it, until you have been taught the proper technique by  your healthcare provider and you understand the instructions. Ask your healthcare provider or  pharmacistif you have any questions about injecting Omnitrope.

Human Growth Hormone 

This leaflet is part III of a three-part “Product Monograph”  published when Genotropin was approved for sale in Canada  and is designed specifically for Consumers. This leaflet is a  summary and will not tell you everything about Genotropin.  Contact your doctor if you have any questions about the drug. 

What the medication is used for: 

In children, Genotropin is used to treat the following growth  problems: 

If you are not growing properly and you do not have  enough of your own growth hormone. 

If you have Turner syndrome. Turner syndrome is a  chromosomal error in girls that can affect growth – your doctor will have told you if you have this. 

If you were small or too light at birth. Growth  

hormone may help you grow taller if you have not  been able to catch up or maintain normal growth by  two years of age or later. 

If you have idiopathic (unknown cause) short stature. 

In adults, Genotropin is used to treat persons with pronounced  growth hormone deficiency. This can start during adult life,  or it can continue from childhood. 

If you have been treated with Genotropin for growth hormone  deficiency during childhood, your growth hormone status will  be retested after completion of growth. If severe growth  hormone deficiency is confirmed, your doctor will propose  continuation of Genotropin treatment. 

What it does: 

Genotropin is a recombinant human growth hormone (also  called somatropin). It has the same structure as natural human  growth hormone which is needed for bones and muscles to  grow. It also helps your fat and muscle tissues to develop in  the right amounts. Recombinant means it is made using  bacteria instead of being taken out of human or animal tissue. 

When it should not be used: 

You are allergic (hypersensitive) to somatropin or any of  the other ingredients of Genotropin. 

You have an active tumour. Tumours must be inactive  and you must have finished your anti-tumour treatment  before you start using Genotropin. 

You are seriously ill (for example, complications  following open heart surgery, abdominal surgery, acute  respiratory failure, accidental trauma or similar  conditions). If you are about to have, or have had, a  

major operation, or go into hospital for any reason, tell  your doctor and remind the other doctors you are seeing  that you use growth hormone. 

Genotropin has been prescribed to stimulate growth but  you have already stopped growing (the growth plates on  your long bones are closed). 

In patients with Prader-Willi syndrome who are very  obese or have severe breathing problems. There have  been reports of deaths in children with Prader-Willi  syndrome who were treated with growth hormone and had  one or more of the following risk factors: severe obesity,  breathing problems, colds or lung infections. 

In patients with diabetic retinopathy, a complication of  diabetes that results from damage to the blood vessels of  the light-sensitive tissue at the back of the eye (retina). 

What the medicinal ingredient is: 

Genotropin is a recombinant human growth hormone (also  called somatropin). 

What the important nonmedicinal ingredients are: Each cartridge in the pre-filled pen contains 5mg, 5.3 mg or  12 mg of somatropin. The Genotropin powder contains  glycine, sodium dihydrogen phosphate anhydrous, disodium  phosphate anhydrous and mannitol. 

The diluent (solution for dissolving somatropin) contains  water for injection, mannitol and metacresol. 

What dosage forms it comes in: 

Genotropin is presented in a cartridge with two sections that is  contained in a multi-dose, disposable pre-filled pen called  GoQuick. One section contains the powder for solution for  injection and the other contains the liquid for solution for  injection. The powder is white and the liquid is clear. 

When mixed together, the powder and the liquid make 1 ml of  solution for injection. 

Genotropin is available in pack sizes of 1 GoQuick pre-filled  pen and 5 GoQuick pre-filled pens. Not all strengths and pack  sizes are marketed in Canada.

GENOTROPIN* (somatropin for injection) 

IMPORTANT: PLEASE READ 

BEFORE using Genotropin, the patient or caregiver  should tell the doctor: 

If the patient is at risk of developing diabetes, the doctor  will need to monitor their blood sugar level during  treatment with Genotropin. 

If the patient has diabetes, they should closely monitor  their blood sugar level during treatment with Genotropin  and discuss the results with their doctor to determine  whether they need to change the dose of their medicines  to treat diabetes. 

If the patient is receiving treatment with thyroid hormones  it may be necessary to adjust their thyroid hormone dose. If the patient is taking growth hormone to stimulate  growth and walk with a limp or if they start to limp during  their growth hormone treatment due to pain in their hip,  they should inform their doctor. 

If the patient develops a strong headache, visual  disturbances or vomiting they should inform their doctor  about it. 

If their doctor confirms that the patient has developed  inflammation of the muscles near the injection site  because of the preservative metacresol, they should use a  Genotropin product without metacresol. 

If the patient is receiving Genotropin for growth hormone  deficiency following a previous tumour, they should be  examined regularly for recurrence of the tumour. If the patient is a survivor of childhood cancer. 

If the patient, especially a child, develops severe  abdominal pain (inflammation of the pancreas). 

If the patient is, or plans to become pregnant or is breast feeding. 

If the patient develop a limp while being treated with  GENOTROPIN. 

If the patient has Turner syndrome and develops an ear  infection or headaches her doctor should be told about  these problems. 

If the patient has hypopituitarism and is receiving  standard hormone replacement therapy, the doctor should  monitor the hormone replacement therapy closely during  GENOTROPIN treatment. 

After starting Genotropin treatment some patients may need to  start thyroid hormone replacement. 

Progression of pre-existing scoliosis (curvature of the spine)  can occur in children who have rapid growth. 

The patient should not use Genotropin if they are pregnant or  are trying to become pregnant. 

Please tell your doctor or pharmacist if you are using or have  recently used any other medicines, including medicines  obtained without a prescription. 

You should tell your doctor if you are using: 

medicines to treat diabetes, 

thyroid hormones, 

synthetic adrenal hormones (corticosteroids), 

sex hormones (for example estrogens), 

cyclosporine (a medicine that weakens the immune  system after transplantation), 

medicines to control epilepsy (anticonvulsants). 

Your doctor may need to adjust the dose of these medicines or  the dose of Genotropin. 

Recommended dosage 

The dose depends on your size, the condition for which you  are being treated and how well growth hormone works for  you. Everyone is different. Your doctor will advise you about  your individualized dose of Genotropin in milligrams (mg)  from either your body weight in kilograms (kg), as well as  your treatment schedule. Do not change the dosage and  treatment schedule without consulting your doctor. 

Children with growth hormone deficiency: 

0.16-0.24 mg/kg body weight per week. Higher doses can be  used. When growth hormone deficiency continues into  adolescence, Genotropin should be continued until completion  of physical development. 

Children with Turner syndrome: 

0.33 mg/kg body weight per week. 

Children with idiopathic short stature: 

UP TO 0.47 mg/kg body weight per week 

Children born smaller or lighter than expected and with  growth disturbance: 

UP TO 0.48 mg/kg body weight per week. Your doctor will  determine the most appropriate dose and length of treatment.  Treatment should be discontinued if: i) after the first year if  you are not responding or ii) if you have reached your final  height and stopped growing. 

Adults with growth hormone deficiency: 

You should start with 0.15-0.3 mg per day. 

This dosage should be gradually increased or decreased  according to blood test results as well as clinical response and  side effects. 

Follow the instructions given to you by your doctor. 

Injecting Genotropin 

Genotropin is intended for subcutaneous use. This means that  it is injected through a short injection needle into the fatty  tissue just under your skin. Your doctor should have already shown you how to use Genotropin. Always inject Genotropin  exactly as your doctor has told you. You should check with  your doctor or pharmacist if you are not sure.

GENOTROPIN* (somatropin for injection) Product Monograph Page 59 of 90 

IMPORTANT: PLEASE READ 

Read carefully the GoQuick Instructions for Use included  in this package leaflet. You must use the pen as described  in the Instructions for Use. 

The needle must be screwed on to the GoQuick pen before  mixing. Use a new needle before each injection. Needles must  not be re-used. 

Preparing the injection: 

You can take your Genotropin out of the refrigerator half an  hour before your injection. This lets it warm up slightly and  can make your injections more comfortable. 

The two-chamber cartridge that contains both the growth  hormone and the dissolving liquid is contained in the GoQuick  pen. The growth hormone and the dissolving liquid are mixed  together by twisting the cartridge holder (see the detailed steps  in Instructions for Use). Dissolve the powder by gently  tipping the GoQuick pen back and forth 5-10 times until the  powder is dissolved. 

When you are mixing your Genotropin, DO NOT SHAKE the pen. Mix it gently. Shaking the solution could make your  growth hormone foam and damage the active substance.  Check the solution and do not inject if the solution is cloudy  or has particles in it.  

Injecting Genotropin: 

Remember to wash your hands and clean your skin first. 

Inject your growth hormone at about the same time every day.  Bedtime is a good time because it is easy to remember. It is  also natural to have a higher level of growth hormone at night. 

Most people do their injections into their thigh or their bottom.  Do your injection in the place you have been shown by your  doctor. Fatty tissue of the skin can shrink at the site of  injection. To avoid this, use a slightly different place for your  injection each time. This gives your skin and the area under  your skin time to recover from one injection before it gets  another one in the same place. 

Remember to put your Genotropin back in the refrigerator  straight after your injection. 

If you use more Genotropin than you should 

If you inject much more than you should, contact your doctor  or pharmacist as soon as possible. Your blood sugar level  could fall too low and later rise too high. You might feel  shaky, sweaty, sleepy or “not yourself”, and you might faint. 

If you forget to use Genotropin 

Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone regularly. If you forget  to use a dose, have your next injection at the usual time the  next day. Keep a note of any missed injections and tell your  doctor at your next check-up. 

If you stop using Genotropin 

Ask for advice from your doctor before you stop using  Genotropin. 

If you have any further questions on the use of this product,  ask your doctor or pharmacist. 

Like all medicines, Genotropin can cause side effects, although  not everybody gets them. 

Common side effects (likely to occur in fewer than 1 in 10  patients) include: 

Formation of antibodies to the injected growth hormone but  these do not seem to stop the growth hormone from working. 

In children: 

Temporary reddening, itchiness or pain at the  

injection site. 

In adults: 

Numbness / tingling, 

Stiffness in the arms and legs, joint pain, muscle  

pain, 

Water retention (which shows as puffy fingers or  swollen ankles). These symptoms may be seen for  a short time at the start of treatment, but they  

disappear spontaneously or when the dosage is  

lowered. 

These common side effects in adults may start within  the first months of treatment and may either stop  

spontaneously or if your dose is reduced. 

Uncommon side effects (likely to occur in fewer than 1 in  100 patients) include: 

In children:  

Numbness / tingling, 

Stiffness in the arms and legs, joint pain, muscle  

pain, 

Water retention (which shows as puffy fingers or  swollen ankles, for a short time at the start of  

treatment). 

In adults: 

Pain or burning sensation in the hands or  

underarms (known as Carpal Tunnel Syndrome). 

Rare side effects (likely to occur in fewer than 1 in 1,000  patients) include: 

Type 2 diabetes mellitus, 

Intracranial hypertension (increased pressure within  the skull due to swelling of the brain) which causes  symptoms such as a strong headache that doesn’t go  

away, vision problems, nausea or vomiting. Call your  doctor if the patient has any of these symptoms.

GENOTROPIN* (somatropin for injection)

IMPORTANT: PLEASE READ 

Very rare side effects (likely to occur in fewer than 1 in  10,000 patients) include: 

Leukemia. 

The skin around the injection area can get uneven or lumpy,  but this should not happen if you inject in a different place  each time. 

A very rare side effect that can occur because of the  preservative metacresol is inflammation of the muscles near  the injection site. If your doctor confirms that you have  developed this, you should use a Genotropin product without  metacresol. 

Slipped capital femoral epiphysis and Legg-Calve-Perthes  disease may be considered by your doctor if discomfort or  pain in the hip or knee is experienced whilst being treated with  Genotropin. 

If any of the side effects gets serious, or if you notice any side  effects not listed in this leaflet, please tell your doctor or  pharmacist. 

This is not a complete list of side effects. For any  unexpected effects while taking Genotropin, contact your  doctor or treatment center. 

Keep out of the reach and sight of children. 

Do not use Genotropin after the expiry date which is stated on  the pack. The expiry date refers to the last day of that month. 

Before mixing the powder with the liquid, your growth  hormone should be stored in a refrigerator (2° to 8°C) until no  later than the expiry date. It can be stored for a maximum of 4  weeks unrefrigerated (at or below 25 C). During and/or at the  end of the 4 weeks period, the product should not be put back  in the refrigerator. After this it must be discarded. 

Genotopin is sensitive to light. You should keep the GoQuick  pen in the outer carton in order to protect your Genotropin  from light. 

After mixing the powder with the liquid, Genotropin must be  stored in a refrigerator (2° to 8°C), for up to 4 weeks. If you  use the needle guard, store your pen with the needle guard and  black cap in place. If you do not use the needle guard, store  your pen with the white pen cap in place. See the Instructions  for Use. These measures will help to protect your Genotropin  from light.  

Do not freeze or expose Genotropin to frost. If it freezes, do  not use it. 

Never throw away needles with your ordinary garbage. When  you have finished with a needle, you must discard it carefully  

so that no-one will be able to use it or prick themselves on it.  You can get a special “sharps” bin from your hospital or  growth clinic. 

Medicines should not be disposed of via wastewater or  household waste. Ask your pharmacist how to dispose of  medicines no longer required. These measures will help to  protect the environment. 

This document plus the full product monograph, prepared for  health professionals can be found at www.pfizer.ca or can be  obtained by contacting the sponsor, Pfizer Canada Inc., at:  1-800-463-6001 (Medical Information)  

This leaflet was prepared by Pfizer Canada Inc.  Last revised: 23 December 2014

HUMATROPE® M

somatropin

Biosynthetic Human Growth Hormone of Recombinant DNA Origin—Growth Stimulant Lilly

Date of Revision: September 16, 2021

IMPORTANT: PLEASE READ: This leaflet is for patients and caregivers. It is Part III of a three-part “Product Monograph” published when HUMATROPE was approved for sale in Canada. This leaflet is a summary and will not tell you everything about HUMATROPE. Contact your doctor or pharmacist if you have any questions about the drug.

Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. Keep this pamphlet since you may need to refer to it after starting treatment with HUMATROPE.

About This Medication: What the medication is used for:

HUMATROPE is used to treat children and teenagers who are short or growing too slowly due to a medical condition such as growth hormone deficiency, Turner syndrome, idiopathic short stature, SHOX (short stature homeobox-containing gene) deficiency, or being born small for gestational age.

HUMATROPE is also used in some adults who had growth hormone deficiency when they were children and still have growth hormone deficiency after they finish growing, or who do not make enough growth hormone as adults for some other reason.

What it does:

HUMATROPE is used to increase growth hormone levels. It stimulates bone growth in children unless the ends of the bones have hardened (closed epiphyses). In both adults and children with growth hormone deficiency, it also increases the growth of muscle and reduces body fat.

When it should not be used:

Treatment should not be started:

• in children to promote growth when the ends of the long bones have hardened (closed epiphyses). Treatment should be stopped when adult height is reached. Réévaluation to find out whether the patient still has growth hormone deficiency will determine if continued treatment with HUMATROPE at a lower dose would be beneficial.
• in patients with any evidence of an active cancer (either newly diagnosed or recurrent).
• while patients have a serious illness following heart or abdominal surgery, or in patients who have just had a serious accident, or those with acute respiratoryfailure (low level of oxygen in the blood or high level of carbon dioxide in the blood).
• in patients with Prader-Willi syndrome who are very obese or have severe breathing problems. There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severe obesity, breathing problems, colds or lung infections.

Treatment should not be started

• in patients known to be allergic to somatropin (the active substance in HUMATROPE), or to any of the ingredients in the powder or the diluent (listed below).
• in patients who have undergone kidney transplant, until one year post-transplant.
• in patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).

What the medicinal ingredient is:

Somatropin (recombinant human growth hormone).

What the important nonmedicinal ingredients are:

The HUMATROPE powder contains freeze-dried somatropin, dibasic sodium phosphate, glycine, and mannitol. The diluent (solution for dissolving somatropin) contains metacresol and glycerin.

Phosphoric acid and/or sodium hydroxide may have been added at the time of manufacture to adjust the acidity of the liquid. What dosage forms it comes in:

HUMATROPE is supplied as follows:

Cartridges: 6 mg, 12 mg, or 24 mg cartridges, each with 3.15 mL of diluent.

HUMATROPE cartridges require the use of a HumatroPen to inject the drug. HumatroPens are supplied separately.

Warnings and Precautions:

Serious Warnings and Precautions

A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use HUMATROPE. After the HUMATROPE powder has been dissolved it must be water-clear and free of particles.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms seem the same as yours.

When medicine is injected into the same place over a long time, it can cause loss of fat tissue under the skin. It is therefore important to keep changing the injection site, and the doctor or nurse can tell you how.

Before using HUMATROPE, the patient or caregiver should tell the doctor:

• if the patient has an active brain tumour or any other tumour (either benign or cancerous). However, the doctor may prescribe HUMATROPE if the patient has had a brain tumour and needs no more anti-tumour treatment for it. The patient should be re-examined frequently to make sure that the tumour has not come back or started to grow.
• if the patient is a survivor of childhood cancer.
• if the patient is very ill after a serious operation, or after being treated for multiple injuries from an accident, or if the patient has sudden serious breathing problems.
• if the patient has diabetes (because more or less insulin may be needed when taking HUMATROPE).
• if a member of the patient’s family has diabetes.
• if the patient is taking a steroid medication (glucocorticoid) such as cortisone or prednisone. This is because the combination may reduce the success of the HUMATROPE treatment or because more of the steroid medication may be needed when the patient is also taking HUMATROPE.
• if the patient is taking a medication known to be metabolized by certain liver enzymes (e.g., cyclosporine, some anticonvulsants, and hormones such as estrogen and birth control pills). This is because the treatment with HUMATROPE may reduce the effectiveness of these drugs.
• if the patient, especially a child, develops abdominal pain.
• if the patient is or plans to become pregnant, or is breast-feeding.
• if the patient has hypothyroidism (low levels of thyroid hormone), because HUMATROPE may reduce the levels of thyroid hormone. The patient may require a change in dosage of his or her thyroid hormone medication.
• if the patient suffers from a bad headache or frequent headaches, or from problems with eyesight, vomiting or feeling sick. Very rarely, swelling of the brain may develop, and the doctor may want to examine the patient to look for signs of brain swelling. If this occurs it may be necessary to stop HUMATROPE treatment.
• if the patient develops a limp, or has hip or knee pain while being treated with HUMATROPE;
• if the patient has known hypersensitivity to somatropin or to any ingredient in the formulation.

If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.

If the patient is growth hormone-deficient and also has Prader-Willi syndrome (a genetic disorder), the doctor should examine the patient for breathing problems and airway infections before starting HUMATROPE treatment, especially if the patient is overweight, has previously experienced severe breathing problems (especially during sleep), or suffered infection of the lungs or airways. If during treatment the patient has signs of breathing problems (snoring), treatment should be interrupted and the cause assessed by the doctor.

Treatment with HUMATROPE can change blood sugar levels.

The doctor should check the patient’s blood sugar regularly while taking HUMATROPE, especially if there are risk factors for diabetes. Patients who have diabetes or impaired glucose tolerance should have their blood sugar closely monitored during HUMATROPE therapy.

Leukemia has been reported in a small number of pediatric patients who have been treated with growth hormone, including growth hormone of pituitary origin, and man-made growth hormone products such as somatrem and somatropin. The relationship, if any, between leukemia and growth hormone is uncertain.

Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth. HUMATROPE has not been shown to increase the occurrence of scoliosis.

If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during HUMATROPE treatment.

If the patient has a growth disorder associated with being born small for gestational age, the blood sugar and insulin levels should be checked before starting treatment and regularly during treatment.

Patients over 65 years of age may be more sensitive to HUMATROPE and may require lower dose of HUMATROPE.

Interactions with This Medication:

Tell the doctor If the patient Is taking any of the following drugs:

• Steroid medications such as glucocorticoids (e.g., cortisone or prednisone)
• Medications known to be metabolized by certain liver enzymes (e.g., cyclosporine, some anticonvulsants, and hormones such as estrogen and birth control pills)
• Insulin and antl-hyperglycemlc agents

Because HUMATROPE may affect how some hormones, such as Cortisol and cortisone, are processed In the body, people may discover that they have an underactive adrenal gland after starting HUMATROPE therapy. In these cases, glucocorticoid replacement therapy would need to be started. If already on glucocorticoid therapy, dosage may need to be adjusted.

Proper Use of This Medication:

Be sure to change the Injection site frequently to help prevent llpoatrophy (loss of fat tissue under the skin). In general, HUMATROPE should be Injected In the evening or before bedtime.

Usual dose:

The doctor will Instruct you on what Is the best dose of HUMATROPE for you (or your child) based on Individual needs. Use HUMATROPE exactly as the doctor tells you to.

Reconstitution Instructions:

Please refer to the enclosed Reconstitution Instructions for HUMATROPE Cartridges:. Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Long-term overdosage or using HUMATROPE after the growth plates in the long bones have closed (hardened) may result in joint pain and continued growth of fingers, toes, nose, ears or jaw. If you think this is happening, tell the doctor.

Overdose may change blood sugar levels, and patients may experience symptoms of hypoglycemia (low blood sugar), such as feeling shaky, dizzy and unwell or hyperglycemia (high blood sugar), such as increased urination or thirst.

Missed dose:

Contact your physician or pharmacist if you have missed a dose.

Side Effects and What to Do About Them:

Some people may be allergic to the diluent (liquid used to mix with the HUMATROPE powder). If there is any pain or redness at the injection site, or if there is any swelling, tell your doctor.

Rarely, more severe allergic reactions may occur. Seek immediate medical help if you (or your child) experience any sudden trouble breathing, with swelling of the hands, feet or face.

Children treated with HUMATROPE may have an increased risk of developing an inflammation of the pancreas called pancreatitis. If your child develops severe abdominal pain, contact your doctor.

It is also important to have blood glucose checked if the patient has diabetes or a family history of diabetes.

HUMATROPE may affect the way the body handles sugars from food and drink. The doctor may need to check the amount of sugar in the urine or blood.

HUMATROPE can affect the amount of thyroid hormone in the blood, so patients must have thyroid function tests from time to time. If the thyroid is not working properly, HUMATROPE may not work as well as it should.

Any child who begins to limp must be examined by a doctor.

HUMATROPE may cause intracranial hypertension (increased pressure within the skull). Call the doctor if the patient has: a headache that doesn’t go away or is severe, or has headaches that become more frequent; problems with vision; nausea (feeling sick in the stomach) or vomiting.

Other possible side effects include headaches, muscle or joint pains (in hips or knees), swelling associated with tingling sensations in the hands, feeling weak, rarely high blood pressure, shortness of breath, and sleep apnea (pauses in breathing during sleep). If the headaches are bad or frequent, and accompanied by sickness or vision problems, tell the doctor immediately.

For patients with Turner syndrome, HUMATROPE therapy may increase the already high frequency of ear infections. Your child should see her doctor if you think she has an ear infection.

This is not a complete list of side effects. If any of the side effects gets serious, or if you notice any unexpected side effects while taking HUMATROPE, contact your doctor or healthcare professional.

How to Store It:

Before it has been reconstituted (mixed):

Store HUMATROPE cartridges and diluent in the refrigerator at 2-8°C (36-46°F).

After it has been reconstituted (mixed):

When the cartridge is prepared with the supplied diluent, it may be stored in the refrigerator at 2-8°C (36-46°F) and MUST be used within 28 DAYS. Do NOT freeze.

Keep out of reach of children.

Reporting Suspected Side Effects

Reporting Suspected Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More Information:

For more information, please contact your healthcare professional or pharmacist first, or Eli Lilly Canada Inc. at: 1-888-545-5972, or visit the website at: www.lilly.ca

The information in this document is current as of the last revision date shown above. For the most current information please visit our website or contact us directly.

This leaflet was prepared by Eli Lilly Canada Inc.

chorionic gonadotropin Human Gonadotropin Organon DIN(s): 02182904

Date of Revision: March 30, 2021

Pharmacology

The action of human chorionic gonadotropin (hCG) is virtually identical to that of pituitary LH, although hCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.

Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.

hCG has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution. Following IM administration, an increase in serum chorionic gonadotropin concentrations may be observed within 2 hours. Peak concentrations occur within 6 hours and persist for approximately 36 hours. Serum chorionic gonadotropin levels begin to decline at 48 hours reaching undetectable levels after 72 hours. Chorionic gonadotropin is distributed primarily in the testes and ovaries of the male and female respectively, with small amounts possible distributing into the proximal tubules of the renal cortex.

Blood levels of chorionic gonadotropin decline in a biphasic manner. The initial phase half-life has been reported between 5.6 and 11 hours, whereas the terminal phase half-life has been reported between 23 and 37.2 hours. Following IM administration of therapeutic doses, approximately 10-12% of the dose is excreted in urine within 24 hours.

Indications

Pregnyl (chorionic gonadotropin for injection, USP) is indicated for:

1. Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future.
2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
3. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with FSH-containing preparations.

NOTE: hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

Contraindications

Pregnyl (chorionic gonadotropin for injection, USP) is contraindicated for prepubertal boys with signs of anatomical obstruction and for patients with:

4. Precocious puberty.
5. Hypersensitivity to this drug or to any ingredient in the formulation or component of the container (see Warnings and Precautions).
6. Known or suspected sex hormone-dependent tumours, such as ovary, breast and uterine carcinoma in female and prostatic or breast carcinoma in the male.
7. Malformations of the reproductive organs incompatible with pregnancy.
8. Fibroid tumours of the uterus incompatible with pregnancy.
9. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

Warnings

hCG should be used in conjunction with FSH-containing preparations only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings and precautions, and adverse reactions described in the package insert for FSH-containing preparations.

The drug substance of this product is manufactured from human urine. Although the risk is theoretical, and no case of transmission of an infectious agent linked to the use of urine-derived gonadotropins has ever been identified, the risk of transmitting infectious agents cannot be completely excluded.

Anaphylaxis and other hypersensitivity reactions have been reported with urinary derived hCG products.

For Males and Females

Hypersensitivity Reactions

10. Hypersensitivity reactions, both generalized and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontinue Pregnyl and assess for other potential causes for the event. (See )

General

11. Patients should be evaluated for uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) and appropriate specific treatment given.
12. Pregnyl should not be used for body weight reduction. hCG has no effect on fat metabolism, fat distribution or appetite.

In the Female

Multi-Fetal Gestation and Birth

13. In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiple pregnancies.

Ectopic Pregnancy

14. Infertile women undergoing Assisted Reproductive Technologies (ART) have an increased incidence of ectopic pregnancy. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Pregnancy Loss

15. Rates of pregnancy loss in women undergoing assisted reproductive technologies (ART) are higher than in the normal population.

Congenital Malformations

16. The incidence of congenital malformations after assisted reproductive technologies may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproductive technologies. There are no indications that the use of gonadotropins during assisted reproductive technologies is associated with an increased risk of congenital malformations.

Ovarian Hyperstimulation Syndrome (OHSS)

17. OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnea, oliguria, hematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.

Adherence to the recommended Pregnyl dose and treatment regimen is advised. Care should be taken with the administration of Pregnyl because OHSS may be triggered by administration of human Chorionic Gonadotropin (hCG). OHSS may also be triggered by pregnancy (endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.

Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Pregnyl. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.

Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART). Careful monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment, the concurrent determination of serum estradiol levels may also be useful. In ART, there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.

For patients at increased risk of OHSS or if OHSS develops, standard and appropriate management of OHSS should be implemented and followed.

Ovarian Torsion

18. Ovarian torsion has been reported after treatment with gonadotropins, including Pregnyl. Ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

Vascular Complications

Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Pregnyl. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.

In the Male

Antibody Formation

19. Administration of hCG can provoke the formation of antibodies against hCG. In rare cases, this may result in an ineffective treatment.

Treatment with hCG Leads to Increased Androgen Production. Therefore

20. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy, migraine or asthma (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.
21. hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.

Neurologic

As far as known this medicine has no influence on alertness and concentration.

Special Populations

Pregnancy

Pregnyl should not be used after pregnancy is established. Lactation

Pregnyl must not be used during lactation.

Precautions Drug Interactions

Interactions of Pregnyl (chorionic gonadotropin for injection, USP) with other medicines have not been investigated; interactions with commonly used medicinal products can therefore not be excluded.

Following administration, Pregnyl may interfere for up to ten days with the immunological determination of serum/urinary hCG, leading to a false positive pregnancy test.

Adverse Effects

Adverse Drug Reaction Overview

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia as well as pain at the injection site have been reported during treatment with Pregnyl (chorionic gonadotropin for injection, USP). Ovarian cancer has also been reported in a very small number of infertile women who have been treated with fertility drugs. A causal relationship between treatment with fertility drugs and ovarian cancer has not been established.

Clinical Trial Adverse Drug Reactions

Clinical trials are conducted under very specific conditions and therefore, the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another member of the therapeutic class. Frequencies of adverse drug reactions from clinical trials with Pregnyl is not available because that information was not being collected by the system used in current drug development.

Post-Market Adverse Drug Reactions

General Disorders and Administrative Site Conditions

Pregnyl may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. Occasionally allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site. Weight gain has been observed as part of the clinical picture of severe OHSS.

Immune System Disorders

In rare cases generalized rash or fever may occur.

In the Female

Gastrointestinal Disorders

abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS. Ascites, as a complication of severe OHSS.

Reproductive and Breast Disorders

unwanted ovarian hyperstimulation, mild or severe OHSS (see Warnings and Precautions). Painful breasts, mild to moderate enlargement of ovaries and ovarian cysts related to mild OHSS. Large ovarian cysts (prone to rupture), usually associated with severe OHSS.

Respiratory. Thoracic and Mediastinal Disorders

hydrothorax, as a complication of severe OHSS.

Vascular Disorders

In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see Warnings and Precautions).

In the Male

Metabolism and Nutrition Disorders

Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.

Reproductive System and Breast Disorders

hCG treatment may sporadically cause gynecomastia.

Overdose

For management of a suspected drug overdose, contact your regional Poison Control Centre. See the CPS Directory section for a list of Poison Control Centres.

Dosage

FOR INTRAMUSCULAR USE ONLY after reconstitution of the dry powder with the sterile diluent. Although the dosac regimen will depend upon the indication, the patient’s age and weight, and the preserver’s preference, the following regimens have been advocated by various authorities.

Males

Prepubertal Cryptorchidism Not Due to Anatomical Obstruction

4000 USP units, 3 times weekly, for 2 to 3 weeks, or 1000 USP units, 3 times weekly for 6 to 8 weeks. The dosage schedule may vary to some extent, depending upon the age when treatment is given. If the dosage is adequate, there will usually be some indication, following one such course of therapy, whether descent will occur or surgery be required.

A therapeutic trial with chorionic gonadotropin may constitute a valuable diagnostic aid to determine the need for surgery. Lack of response is usually an indication of anatomic obstruction. Furthermore, when surgery is required, the preliminary treatment may facilitate the procedure by increasing the size of the testes and the length of the cords. Postoperative gonadotropic therapy has also been suggested to prevent retraction of testes.

Age of initiation of treatment: Various ages ranging from early childhood to immediately before expected puberty have been suggested. The average appropriate age, however, appears to be 12 years.

Selected Cases of Hypogonadotropic Hypogonadism in Males

4000 to 5000 USP units 3 times weekly for 6 to 8 weeks with a rest of period of 2 to 3 weeks between courses of therapy.

Females

Induction of ovulation and pregnancy in the anovulatory infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with FSH-containing preparations (see prescribing information of FSH-containing preparations for dosage and administration for those drug products).

5000 to 10 000 USP units one day following the last day of treatment with an FSH-containing preparation (a dosage of 10 000 USP units is recommended in the labeling of FSH-containing preparations).

Stability and Storage Recommendations

Store at 15-30°C.

Reconstituted solution is stable for 28 days when refrigerated (2-8°C).

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Reconstituted Solution

Direction for Reconstitution

Reconstitute Pregnyl 10 000 USP units to the desired concentration by addition of the required amount of the solvent supplied. Remove 1 to 10 ml. of the solvent and add to the vial with the lyophilized Pregnyl, agitate gently until the powder is completely dissolved.

When reconstituted with 10 ml_ of the solvent, the concentration of Chorionic Gonadotropin is 1000 USP units/mL. The solvent contains 0.9% benzyl alcohol.

Supplied

Each vial of Pregnyl contains: 10 000 USP units of sterile lyophilized human chorionic gonadotropin plus 5 mg of monobasic sodium phosphate monohydrate and 4.4 mg of dibasic sodium phosphate anhydrous (pH may have been adjusted with sodium hydroxide and/or phosphoric acid). Each vial of Pregnyl solvent contains: 10 ml_ of Water for Injection, 0.9% of benzyl alcohol, 0.56% sodium chloride and trace amount of sodium hydroxide and/or hydrochloric acid. Packages of 2 vials: one multi-dose vial of Pregnyl (chorionic gonadotropin for injection, USP) 10 000 USP units plus one vial of 10 ml_ sterile Pregnyl solvent.

This product monograph was developed by the pharmaceutical manufacturer in accordance with the requirements of Health Canada. CPhA recommends that the full monograph be used. Partial monographs should not be provided to patients or anyone else and are for use only by clients at their own risk. CPhA assumes no responsibility for or liability in connection with the use of this monograph. Once printed, there is no guarantee the information is up-to-date. [Printed on: 09-23-2024 12:22 PM]

CPS, Drug Information © Canadian Pharmacists Association, 2024. All rights reserved

What it does:

DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPOTESTOSTERONE helps raise your testosterone to normal levels.

When it should not be used:

• if you have prostate or breast cancer (confirmed or suspected by your doctor)
• if you have difficulty in urinating due to an enlarged prostate
• if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE, including testosterone USP that is chemically synthesized from soy (see “What the medicinal and nonmedicinal ingredients are” in this section).

DEPO-TESTOSTERONE should NOT be used by women. Pregnant and breast-feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

DEPO-TESTOSTERONE is available in one strength, 100 mg

testosterone cypionate /mL.

DEPO-TESTOSTERONE is available in the following packaging:

100 mg per mL – In vials of 10 mL.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.

DEPO-TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome” (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.

Pregnancy: Benzyl alcohol can cross the placenta.

Before using DEPO-TESTOSTERONE, talk to your doctor if you:

• have difficulty urinating due to an enlarged prostate.

Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;

• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea);
• have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.

Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that include:

• Insulin
• Corticosteroids
• Propranolol
• Warfarin

PROPER USE OF THIS MEDICATION

DEPO-TESTOSTERONE should only be administered by a health care professional.

When you are given DEPO-TESTOSTERONE, your blood testosterone should be checked on a regular basis.

Usual dose: 200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:

• skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count, (hematocrit and hemoglobin);
• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or the legs;

This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE 1% GEL

What it does:

TESTOSTERONE 1% GEL delivers medicine into your bloodstream through your skin. TESTOSTERONE 1% GEL helps raise your testosterone to normal levels.

When it should not be used:

• If you have or it is suspected that you have prostate or breast cancer.
• If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are” in this section)].

TESTOSTERONE 1% GEL should NOT be used by women. Pregnant and breast-feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and/or with clothing or other fabrics exposed to TESTOSTERONE 1% GEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate.

What dosage forms it comes in:

TESTOSTERONE 1% GEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

• One 2.5 g packet contains 25 mg of testosterone
• One 5.0 g packet contains 50 mg of testosterone
• One full press of the pump delivers 1.25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

TESTOSTERONE 1% GEL can be transferred to another person when skin-to-skin contact with application site occurs.

• Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
• Keep children away from unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and from unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL.
• Men who use TESTOSTERONE 1% GEL must strictly follow the instructions for use to lower the risk of transferring TESTOSTERONE 1% GEL to another person.

You should prevent TESTOSTERONE 1% GEL from transferring to another person, especially pregnant or breast-feeding women, or children by taking the following precautions:

• Children and women should avoid contact with the application sites on men using TESTOSTERONE 1% GEL.
• TESTOSTERONE 1% GEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
• Wash hands immediately with soap and water after application of TESTOSTERONE 1% GEL.
• Cover the application site(s) with clothing (such as a shirt) after TESTOSTERONE 1% GEL has dried.
• If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any TESTOSTERONE 1% GEL left on the application site(s).
• In the event that an unwashed or uncovered TESTOSTERONE 1% GEL application site and/or unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour. In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits. Any of these changes should be brought immediately to the attention of a doctor. The possibility of exposure to testosterone should be discussed with the doctor.

TESTOSTERONE 1% GEL must not be used by children under the age of 18.

If you are suffering from severe heart, liver or kidney disease, treatment with testosterone may cause serious complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (inadequate pumping of the heart with build-up of fluid in body tissues).

Testosterone may cause a rise in blood pressure. Therefore, TESTOSTERONE 1% GEL should be used with caution if you are suffering from high blood pressure.

In patients receiving long-term TESTOSTERONE 1% GEL therapy, the physician may prescribe regular blood tests, such as testosterone, complete blood count, liver function tests and lipid profile. Testosterone increases red blood cell count which theoretically could increase the risk of blood clots.

Your physician may also monitor your prostate gland for any negative effects of testosterone therapy by performing digital rectal examinations.

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Before using TESTOSTERONE 1% GEL, talk to your doctor if you:

• have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea).
• have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.

Drug Abuse and Dependence:

TESTOSTERONE 1% GEL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Reduction in testicular size (testicular atrophy), limited or complete infertility have been reported in men who abuse anabolic androgenic steroids.

Precautions while using TESTOSTERONE 1% GEL:

Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.

INTERACTIONS WITH THIS MEDICATION:

Be sure to tell your doctor about all other prescription and non-prescription medicines you are taking, if any. Drugs that may interact with TESTOSTERONE 1% GEL include:

• insulin
• corticosteroids
• propranolol
• anti-clotting medications (e.g., warfarin)

PROPER USE OF THIS MEDICATION:

1. Apply TESTOSTERONE 1% GEL at the same time each day, (preferably in the morning). Apply the proper amount of gel every morning as instructed by your doctor. The amount of testosterone you need may be adjusted by your doctor. Always follow your doctor’s recommendations.
2. Be sure your skin is completely dry before applying TESTOSTERONE 1% GEL. For example, if you take a bath or shower in the morning, apply TESTOSTERONE 1% GEL after your bath or shower once your skin is completely dry.
3. Apply TESTOSTERONE 1% GEL only to your abdomen (stomach area), shoulders, and/or upper arms, as shown in the following diagram.

o Use a circular motion to rub in the gel for several seconds. Applying TESTOSTERONE 1% GEL only to the areas shown helps ensure that your body will absorb the right amount of testosterone. TESTOSTERONE 1% GEL may be applied to the same areas of the body each day. It is not necessary to alternate application sites.

o  Never apply TESTOSTERONE 1% GEL to your genitals (penis and scrotum) or to damaged skin.

o  Apply TESTOSTERONE 1% GEL only to healthy, normal skin. Avoid skin with open sores, wounds, sunburn, or irritation.

4. Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.
5. Wash your hands immediately following application.

o  It is important to wash your hands with soap and water right away to reduce the chance that any TESTOSTERONE 1% GEL will spread from your hands to other people.

o  If, however, you expect direct skin contact with someone else, you should wash your application site(s) with soap and water before that encounter. This will reduce the chance that any TESTOSTERONE 1% GEL will transfer to the other person.

6. Let TESTOSTERONE 1% GEL dry for a few minutes before you dress.

o  This prevents your clothing from absorbing or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.

o Wait 5 to 6 hours before showering or swimming. To ensure that TESTOSTERONE 1% GEL is fully absorbed into your system, you should generally wait five to six hours after application before showering or swimming. However, once in a while you may shower or swim as soon as one hour after applying TESTOSTERONE 1% GEL. Although this is not recommended, if done infrequently, it will have little effect on the overall amount of TESTOSTERONE 1% GEL that is absorbed by your body.

o  Transference of TESTOSTERONE 1% GEL to another person can be completely prevented when the application site is covered with a long-sleeved shirt (cotton-polyester blend).

7. It is important that you read and follow the directions below on how to use TESTOSTERONE 1% GEL properly:

Using the TESTOSTERONE 1% GEL packet:

1. Opening the packet:

Open one TESTOSTERONE 1% GEL aluminum foil packet by folding it along the top edge and carefully tearing it open.

1. Applying TESTOSTERONE 1% GEL to your skin:

o Gently squeeze the gel from the bottom of the packet toward the top.

o Squeeze out half (1/2) of the contents of the packet and apply it to the areas of your body shown in the diagram. Use a circular motion to rub in the gel for several seconds. Once you have applied this first half to your skin, squeeze out the second half and apply it in the same manner. Discard the empty packet in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

What should I do if I get TESTOSTERONE 1% GEL in my eyes?

If you get TESTOSTERONE 1% GEL in your eyes, rinse your eyes right away with warm clean water to flush out any TESTOSTERONE 1% GEL. Seek medical attention if discomfort persists.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. If your next dose is less than 12 hours away, it is best to wait. Do not take the skipped dose. If it is more than 12 hours until your next dose, take the dose that you missed. Resume your normal dosing the next day.

Overdose:

Contact your doctor or pharmacist or poison control centre immediately if you suspect an overdose.

If you use more TESTOSTERONE 1% GEL than the recommended dose (an overdose), wash the skin with soap and water where TESTOSTERONE 1% GEL was applied and contact your doctor or pharmacist .

What to do if someone is exposed to the medication:

If someone else is exposed to TESTOSTERONE 1% GEL either by direct contact with the gel itself or indirectly because of contact with your treated skin, that person should wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some testosterone.

This is particularly important for women, especially pregnant or nursing women, and children. Children have naturally low levels of testosterone and could be harmed by higher levels. Pregnant women are at an even higher risk because increased testosterone levels may cause harm or abnormalities in the unborn baby.

Never share your TESTOSTERONE 1% GEL with anyone.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medicines, TESTOSTERONE 1% GEL can have side effects. The following side effects have been reported for products containing testosterone:

• Skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count (hematocrit and hemoglobin);
• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or the legs.
• reduction in testicular size (testicular atrophy), limited or complete infertility

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. See WARNINGS AND PRECAUTIONS.

Changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits in the female partner or in any person (including children) exposed to skin-to- skin contact, should be brought to the attention of a doctor.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE CYPIONATE INJECTION

What it does:

DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPOTESTOSTERONE helps raise your testosterone to normal levels.

When it should not be used:

• if you have prostate or breast cancer (confirmed or suspected by your doctor)
• if you have difficulty in urinating due to an enlarged prostate
• if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE, including testosterone USP that is chemically synthesized from soy (see “What the medicinal and nonmedicinal ingredients are” in this section).

DEPO-TESTOSTERONE should NOT be used by women. Pregnant and breast-feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

DEPO-TESTOSTERONE is available in one strength, 100 mg

testosterone cypionate /mL.

DEPO-TESTOSTERONE is available in the following packaging:

100 mg per mL – In vials of 10 mL.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.

DEPO-TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome” (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.

Pregnancy: Benzyl alcohol can cross the placenta.

Before using DEPO-TESTOSTERONE, talk to your doctor if

you:

• have difficulty urinating due to an enlarged prostate.

Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;

• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea);
• have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.

Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that include:

• Insulin
• Corticosteroids
• Propranolol
• Warfarin

PROPER USE OF THIS MEDICATION

DEPO-TESTOSTERONE should only be administered by a health care professional.

When you are given DEPO-TESTOSTERONE, your blood testosterone should be checked on a regular basis.

Usual dose: 200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:

• skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count, (hematocrit and

hemoglobin);

• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or

the legs;

This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION FOR TESTOSTERONE 1% GEL

What it does:

TESTOSTERONE 1% GEL delivers medicine into your bloodstream through your skin. TESTOSTERONE 1% GEL helps raise your testosterone to normal levels.

When it should not be used:

• If you have or it is suspected that you have prostate or breast cancer.
• If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are” in this section)].

TESTOSTERONE 1% GEL should NOT be used by women. Pregnant and breast-feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and/or with clothing or other fabrics exposed to TESTOSTERONE 1% GEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate.

What dosage forms it comes in:

TESTOSTERONE 1% GEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

• One 2.5 g packet contains 25 mg of testosterone
• One 5.0 g packet contains 50 mg of testosterone
• One full press of the pump delivers 1.25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

TESTOSTERONE 1% GEL can be transferred to another person when skin-to-skin contact with application site occurs.

• Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
• Keep children away from unwashed or unclothed application sites of men using TESTOSTERONE 1% GEL and from unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL.
• Men who use TESTOSTERONE 1% GEL must strictly follow the instructions for use to lower the risk of transferring TESTOSTERONE 1% GEL to another person.

You should prevent TESTOSTERONE 1% GEL from transferring to another person, especially pregnant or breast-feeding women, or children by taking the following precautions:

• Children and women should avoid contact with the application sites on men using TESTOSTERONE 1% GEL.
• TESTOSTERONE 1% GEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
• Wash hands immediately with soap and water after application of TESTOSTERONE 1% GEL.
• Cover the application site(s) with clothing (such as a shirt) after TESTOSTERONE 1% GEL has dried.
• If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any TESTOSTERONE 1% GEL left on the application site(s).
• In the event that an unwashed or uncovered TESTOSTERONE 1% GEL application site and/or unwashed clothing or other fabrics exposed to TESTOSTERONE 1% GEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour. In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits. Any of these changes should be brought immediately to the attention of a doctor. The possibility of exposure to testosterone should be discussed with the doctor.

TESTOSTERONE 1% GEL must not be used by children under the age of 18.

If you are suffering from severe heart, liver or kidney disease, treatment with testosterone may cause serious complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (inadequate pumping of the heart with build-up of fluid in body tissues).

Testosterone may cause a rise in blood pressure. Therefore, TESTOSTERONE 1% GEL should be used with caution if you are suffering from high blood pressure.

In patients receiving long-term TESTOSTERONE 1% GEL therapy, the physician may prescribe regular blood tests, such as testosterone, complete blood count, liver function tests and lipid profile. Testosterone increases red blood cell count which theoretically could increase the risk of blood clots.

Your physician may also monitor your prostate gland for any negative effects of testosterone therapy by performing digital rectal examinations.

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Before using TESTOSTERONE 1% GEL, talk to your doctor if you:

• have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea).
• have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.

Drug Abuse and Dependence:

TESTOSTERONE 1% GEL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Reduction in testicular size (testicular atrophy), limited or complete infertility have been reported in men who abuse anabolic androgenic steroids.

Precautions while using TESTOSTERONE 1% GEL:

Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.

INTERACTIONS WITH THIS MEDICATION:

Be sure to tell your doctor about all other prescription and non-prescription medicines you are taking, if any. Drugs that may interact with TESTOSTERONE 1% GEL include:

• insulin
• corticosteroids
• propranolol
• anti-clotting medications (e.g., warfarin)

PROPER USE OF THIS MEDICATION:

1. Apply TESTOSTERONE 1% GEL at the same time each day, (preferably in the morning). Apply the proper amount of gel every morning as instructed by your doctor. The amount of testosterone you need may be adjusted by your doctor. Always follow your doctor’s recommendations.
2. Be sure your skin is completely dry before applying TESTOSTERONE 1% GEL. For example, if you take a bath or shower in the morning, apply TESTOSTERONE 1% GEL after your bath or shower once your skin is completely dry.
3. Apply TESTOSTERONE 1% GEL only to your abdomen (stomach area), shoulders, and/or upper arms, as shown in the following diagram.

o Use a circular motion to rub in the gel for several seconds. Applying TESTOSTERONE 1% GEL only to the areas shown helps ensure that your body will absorb the right amount of testosterone. TESTOSTERONE 1% GEL may be applied to the same areas of the body each day. It is not necessary to alternate application sites.

o Never apply TESTOSTERONE 1% GEL to your genitals (penis and scrotum) or to damaged skin.

o Apply TESTOSTERONE 1% GEL only to healthy, normal skin. Avoid skin with open sores, wounds, sunburn, or irritation.

4. Following application of TESTOSTERONE 1% GEL, allow gel to dry completely before smoking or going near an open flame.
5. Wash your hands immediately following application.

o It is important to wash your hands with soap and water right away to reduce the chance that any TESTOSTERONE 1% GEL will spread from your hands to other people.

o If, however, you expect direct skin contact with someone else, you should wash your application site(s) with soap and water before that encounter. This will reduce the chance that any TESTOSTERONE 1% GEL will transfer to the other person.

6. Let TESTOSTERONE 1% GEL dry for a few minutes before you dress.

o This prevents your clothing from absorbing or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.

o Wait 5 to 6 hours before showering or swimming. To ensure that TESTOSTERONE 1% GEL is fully absorbed into your system, you should generally wait five to six hours after application before showering or swimming. However, once in a while you may shower or swim as soon as one hour after applying TESTOSTERONE 1% GEL. Although this is not recommended, if done infrequently, it will have little effect on the overall amount of TESTOSTERONE 1% GEL that is absorbed by your body.

o Transference of TESTOSTERONE 1% GEL to another person can be completely prevented when the application site is covered with a long-sleeved shirt (cotton-polyester blend).

7. It is important that you read and follow the directions below on how to use TESTOSTERONE 1% GEL properly:

Using the TESTOSTERONE 1% GEL packet:

1. Opening the packet:

Open one TESTOSTERONE 1% GEL aluminum foil packet by folding it along the top edge and carefully tearing it open.

1. Applying TESTOSTERONE 1% GEL to your skin:

o Gently squeeze the gel from the bottom of the packet toward the top.

o Squeeze out half (1/2) of the contents of the packet and apply it to the areas of your body shown in the diagram. Use a circular motion to rub in the gel for several seconds. Once you have applied this first half to your skin, squeeze out the second half and apply it in the same manner. Discard the empty packet in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

What should I do if I get TESTOSTERONE 1% GEL in my eyes?

If you get TESTOSTERONE 1% GEL in your eyes, rinse your eyes right away with warm clean water to flush out any TESTOSTERONE 1% GEL. Seek medical attention if discomfort persists.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. If your next dose is less than 12 hours away, it is best to wait. Do not take the skipped dose. If it is more than 12 hours until your next dose, take the dose that you missed. Resume your normal dosing the next day.

Overdose:

Contact your doctor or pharmacist or poison control centre immediately if you suspect an overdose.

If you use more TESTOSTERONE 1% GEL than the recommended dose (an overdose), wash the skin with soap and water where TESTOSTERONE 1% GEL was applied and contact your doctor or pharmacist .

What to do if someone is exposed to the medication:

If someone else is exposed to TESTOSTERONE 1% GEL either by direct contact with the gel itself or indirectly because of contact with your treated skin, that person should wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some testosterone.

This is particularly important for women, especially pregnant or nursing women, and children. Children have naturally low levels of testosterone and could be harmed by higher levels. Pregnant women are at an even higher risk because increased testosterone levels may cause harm or abnormalities in the unborn baby.

Never share your TESTOSTERONE 1% GEL with anyone.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medicines, TESTOSTERONE 1% GEL can have side effects. The following side effects have been reported for products containing testosterone:

• Skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count (hematocrit and hemoglobin);
• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or the legs.
• reduction in testicular size (testicular atrophy), limited or complete infertility

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. See WARNINGS AND PRECAUTIONS.

Changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits in the female partner or in any person (including children) exposed to skin-to- skin contact, should be brought to the attention of a doctor.

ANDROGEL®

testosterone Androgens

BGP Pharma ULC dba Viatris

Date of Revision: February 12, 2019 IMPORTANT: PLEASE READ:

This leaflet is Part III of a three-part “Product Monograph” published when ANDROGEL was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about ANDROGEL. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION:

What the medication is used for:

Your doctor has prescribed ANDROGEL because your body is not making enough testosterone. The medical term for this condition is hypogonadism. This should be confirmed by two separate blood testosterone measurements.

What it does:

ANDROGEL delivers medicine into your bloodstream through your skin. ANDROGEL helps raise your testosterone to normal levels.

When it should not be used:

• If you have or it is suspected that you have prostate or breast cancer.
• If you have a known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the non-medicinal ingredients are“ in this section)].

ANDROGEL should NOT be used by women. Pregnant and breast feeding women are especially at risk and should avoid skin contact with application sites on men. Testosterone may cause harm to your unborn baby. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. If skin contact with unwashed or unclothed application sites of men using ANDROGEL and/or with clothing or other fabrics exposed to ANDROGEL occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone USP

What the non-medicinal ingredients are:

Alcohol, purified water, sodium hydroxide, Carbopol 980 and isopropyl myristate. What dosage forms it comes in:

ANDROGEL is a gel containing 1% testosterone. It is supplied either in a pump or foil packets:

• One 5 g packet contains 25 mg of testosterone
• One 0 g packet contains 50 mg of testosterone
• One full press of the pump delivers 25 g of gel which contains 12.5 mg of testosterone.

WARNINGS AND PRECAUTIONS:

Serious Warnings and Precautions:

ANDROGEL can be transferred to another person when skin-to-skin contact with application site occurs.

• Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel.
• Keep children away from unwashed or unclothed application sites of men using ANDROGEL and from unwashed clothing or other fabrics exposed to ANDROGEL.
• Men who use ANDROGEL must strictly follow the instructions for use to lower the risk of transferring ANDROGEL to another person.

You should prevent ANDROGEL from transferring to another person, especially pregnant or breast feeding women, or children by taking the following precautions:

• Children and women should avoid contact with the application sites on men using ANDROGEL.
• ANDROGEL should be applied only to the areas of the shoulders, upper arms, and/or abdomen that will be covered by a short sleeve T-shirt.
• Wash hands immediately with soap and water after application of ANDROGEL.
• Cover the application site(s) with clothing (such as a shirt) after ANDROGEL has dried.
• If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any ANDROGEL left on the application site(s).
• In the event that an unwashed or uncovered ANDROGEL application site and/or unwashed clothing or other fabrics exposed to ANDROGEL does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour. In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits. Any of these changes should be brought immediately to the attention of a doctor. The possibility of exposure to testosterone should be discussed with the doctor.

ANDROGEL must not be used by children under the age of 18.

If you are suffering from severe heart, liver or kidney disease, treatment with testosterone may cause serious complications in the form of water retention in your body, sometimes accompanied by congestive heart failure (inadequate pumping of the heart with build-up of fluid in body tissues).

Testosterone may cause a rise in blood pressure. Therefore, ANDROGEL should be used with caution if you are suffering from high blood pressure.

In patients receiving long-term ANDROGEL therapy, the physician may prescribe regular blood tests, such as testosterone, complete blood count, liver function tests and lipid profile. Testosterone increases red blood cell count which theoretically could increase the risk of blood clots.

Your physician may also monitor your prostate gland for any negative effects of testosterone therapy by performing digital rectal examinations.

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Before using ANDROGEL, talk to your doctor if you:

• have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea).
• have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.

Drug Abuse and Dependence:

ANDROGEL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Reduction in testicular size (testicular atrophy), limited or complete infertility have been reported in men who abuse anabolic androgenic steroids.

Precautions while using ANDROGEL:

Following application of ANDROGEL, allow gel to dry completely before smoking or going near an open flame.

INTERACTIONS WITH THIS MEDICATION:

Be sure to tell your doctor about all other prescription and non-prescription medicines you are taking, if any. Drugs that may interact with ANDROGEL include:

• insulin
• corticosteroids
• propranolol
• anti-clotting medications (e.g., warfarin)

PROPER USE OF THIS MEDICATION:

• Apply ANDROGEL at the same time each day, (preferably in the morning). Apply the proper amount of gel every morning as instructed by your doctor. The amount of testosterone you need may be adjusted by your doctor. Always follow your doctor’s recommendations.
• Be sure your skin is completely dry before applying ANDROGEL. For example, if you take a bath or shower in the morning, apply ANDROGEL after your bath or shower once your skin is completely dry.
• Apply ANDROGEL only to your abdomen (stomach area), shoulders, and/or upper arms, as shown in the following diagram.

Use a circular motion to rub in the gel for several seconds. Applying ANDROGEL only to the areas shown helps ensure that your body will absorb the right amount of testosterone. ANDROGEL may be applied to the same areas of the body each day. It is not necessary to alternate application sites.

 Never apply ANDROGEL to your genitals (penis and scrotum) or to damaged skin.

Apply ANDROGEL only to healthy, normal skin. Avoid skin with open sores, wounds, sunburn, or irritation.

• Following application of ANDROGEL, allow gel to dry completely before smoking or going near an open flame.
• Wash your hands immediately following application.

It is important to wash your hands with soap and water right away to reduce the chance that any ANDROGEL will spread from your hands to other people.

If, however, you expect direct skin contact with someone else, you should wash your application site(s) with soap and water before that encounter. This will reduce the chance that any ANDROGEL will transfer to the other person.

• Let ANDROGEL dry for a few minutes before you dress.

This prevents your clothing from absorbing or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.

Wait 5 to 6 hours before showering or swimming. To ensure that ANDROGEL is fully absorbed into your system, you should generally wait five to six hours after application before showering or swimming. However, once in a while you may shower or swim as soon as one hour after applying ANDROGEL. Although this is not recommended, if done infrequently, it will have little effect on the overall amount of ANDROGEL that is absorbed by your body.

Transference of ANDROGEL to another person can be completely prevented when the application site is covered with a long-sleeved shirt (cotton-polyester blend).

• It is important that you read and follow the directions below on how to use ANDROGEL properly:

See Section A if you are using the ANDROGEL pump

See Section B if you are using the ANDROGEL packets

Section A: Using the ANDROGEL pump:

• Priming the pump:

Before using a new pump for the first time, you must prime the pump to remove the air. Up to five depressions may be needed before all of the air is removed and gel is discharged. The first two depressions that deliver any amount of gel are to be discarded by thoroughly rinsing down the sink or discarding in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

• Determining the number of full depressions (presses of the pump) needed for each dose:

Each full press of the pump delivers 1.25 g of ANDROGEL. Please refer to the chart below to determine the number of full depressions required for the daily dose prescribed by your doctor:

• Number of days of treatment per pump (after priming):

The ANDROGEL pump contains enough gel to allow for priming and a set number of precise doses. Please refer to the chart below to determine the number of days of treatment each pump will provide based on your individual dose. Discard the pump afterwards.

• Applying ANDROGEL to your skin:

Fully press the pump the appropriate number of times to deliver the daily dose prescribed by your doctor. The gel should be delivered directly into the palm of your hand and then applied to the desired application sites, either one pump depression at a time or upon completion of all pump depressions required for the daily dose.

Alternatively, the product can be applied directly to the application sites. Application directly to the sites may prevent loss of product that may occur during transfer from the palm of the hand onto the application sites.

Section B: Using the ANDROGEL packet:

• Opening the packet:

Open one ANDROGEL aluminum foil packet by folding it along the top edge and carefully tearing it open.

• Applying ANDROGEL to your skin:

Gently squeeze the gel from the bottom of the packet toward the top.

Squeeze out half (1/2) of the contents of the packet and apply it to the areas of your body shown in the diagram. Use a circular motion to rub in the gel for several seconds. Once you have applied this first half to your skin, squeeze out the second half and apply it in the same manner. Discard the empty packet in the household trash in a manner that prevents accidental application or ingestion by household members, especially nursing/pregnant women and children.

What should I do if I get ANDROGEL in my eyes?

If you get ANDROGEL in your eyes, rinse your eyes right away with warm clean water to flush out any ANDROGEL. Seek medical attention if discomfort persists.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. If your next dose is less than 12 hours away, it is best to wait. Do not take the skipped dose. If it is more than 12 hours until your next dose, take the dose that you missed. Resume your normal dosing the next day.

Overdose:

Contact your doctor or pharmacist or poison control centre immediately if you suspect an overdose.

If you use more ANDROGEL than the recommended dose (an overdose), wash the skin with soap and water where ANDROGEL was applied and contact your doctor or pharmacist.

What to do if someone is exposed to the medication:

If someone else is exposed to ANDROGEL either by direct contact with the gel itself or indirectly because of contact with your treated skin, that person should wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some testosterone.

This is particularly important for women, especially pregnant or nursing women, and children. Children have naturally low levels of testosterone and could be harmed by higher levels. Pregnant women are at an even higher risk because increased testosterone levels may cause harm or abnormalities in the unborn baby.

Never share your ANDROGEL with anyone.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medicines, ANDROGEL can have side effects. The following side effects have been reported for products containing testosterone:

• Skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);
• an increase in red blood cell count (hematocrit and hemoglobin);
• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;
• headache, dizziness;
• increased or irregular heart rate, blood clot in the lungs or the legs.
• reduction in testicular size (testicular atrophy), limited or complete infertility

Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. See WARNINGS AND PRECAUTIONS.

Changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits in the female partner or in any person (including children) exposed to skin-to- skin contact, should be brought to the attention of a doctor.

MORE INFORMATION:

The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at: www.mylan.ca or by contacting the sponsor, BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6 at: 1­844-596-9526

This leaflet was prepared by BGP Pharma ULC

Information for the Patient handout was developed by the pharmaceutical manufacturer in accordance with the requirements of Health Canadc ZPhA assumes no responsibility for or liability in connection with the use of this handout. Once printed there is no guarantee the information is up-ti late.

Patient Medication Information © Canadian Pharmacists Association, 2024. All rights reserved