Testosterone Gel

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.