Testim 1%: Uses, Side Effects and Dosage

What the medication is used for:

Your doctor has prescribed Testim^® 1% because your body is not making enough testosterone. The medical term for this condition is hypogonadism.

What it does:

Testim^® 1% delivers medicine into your bloodstream through your skin. Testim^® 1% 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.
• 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)].

Testim^® 1% 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 Testim^® 1% or with clothing or other fabrics exposed to Testim^® 1% occurs, pregnant or nursing women should immediately wash the area of contact with soap and water.

What the medicinal ingredient is:

Testosterone

What the nonmedicinal ingredients are:

Carbomers, ethyl alcohol, glycerin, oxacyclohexadecan-2-one, polyethylene glycol, propylene glycol, purified water, tromethamine

What dosage forms it comes in:

Each Testim^® 1 % 5 g tube contains testosterone 1% in a clear to translucent hydroalcoholic topical gel. Testim^® 1% is supplied in unit-dose aluminum tubes with epoxy phenolic liners in cartons of 30.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Testim^® 1% 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 Testim^® 1% and from unwashed clothing or other fabrics exposed to Testim® 1%.
• Men who use Testim^® 1% must follow the instructions for use to lower the risk of transferring Testim^® 1% to another person.

You should prevent Testim^® 1% 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 Testim^® 1%.
• Testim^® 1% should be applied only to the areas of the shoulders and/or upper arms that will be covered by a short sleeve T-shirt.
• Direct skin-to-skin contact should be avoided after applying Testim^® 1%. If direct skin-to-skin contact is anticipated, wash the application site(s) thoroughly with soap and water to remove any Testim^® 1% left on the application site(s).
• Wash hands immediately with soap and water after application of Testim^® 1%;
• Cover the application site(s) with clothing (such as a shirt) after Testim^® 1% has dried;
• In the event that an unwashed or uncovered Testim^® 1% application site 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, premature 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.

Testim^® 1% must not be used by children under the age of 18.

There is very little information from clinical trials with testosterone in the older male (over 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 Testim^® 1%, talk to your doctor if you:

ABOUT THIS MEDICATION

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• 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:

Testim^® 1% contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.

Precautions while using Testim^® 1%:

Following application of Testim^® 1%, allow gel to dry completely before smoking or going near an open fire.

INTERACTIONS WITH THIS MEDICATION

Be sure to inform 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 may interact with Testim^® 1% include:

• Insulin
• Corticosteroids
• Propranolol
• Anti-clotting medications (such as warfarin)

PROPER USE OF THIS MEDICATION

Always use Testim^® 1% as your doctor has instructed you.

Usual dose:

The recommended starting dose of Testim^® 1% is 5 g of gel (one tube) containing 50 mg of testosterone. The gel should be applied once daily (preferably in the morning) to clean, dry intact skin and only to the areas of the shoulders and/or upper arms that will be covered by a short sleeve T-shirt. Some patients will require a higher dose and your doctor may prescribe two tubes of gel every day.

Instructions for Use:

1. 1. Apply Testim^® 1% at the same time each day (preferably every morning).
2. 2. If you take a bath or shower in the morning, use Testim^® 1% after your bath or shower.
3. 3. Make sure that your skin is clean and completely dry before putting on the gel.
4. 4. Open the Testim^® 1% aluminum tube by piercing the end of the tube. Use the top part of the cap to do this.
5. 5.

   Squeeze the entire contents of the tube into the palm of your hand. Squeeze the gel out from the bottom of the tube towards

   1. the top. If you prefer, you can squeeze out a portion at a time and continue until the tube is empty.
   1. 6. Apply Testim^® 1% only to the areas of your shoulders and/or upper arms that will be covered by a short sleeve T-shirt. In this way your body will absorb the right amount of testosterone. Never apply Testim^® 1% to your genitals (penis and scrotum), sunburned areas of the body, or to skin that is not completely normal. Apply Testim^® 1% only to healthy, normal skin. Avoid contact with open sores, wounds or irritations.
   2. 7. Use a circular motion to rub the gel in to your skin for several seconds. Do this until the gel is well rubbed in and the skin area feels dry.
   3. 8. Thoroughly wash your hands with soap and water immediately after application to reduce the chance that the medicine will spread from your hands to other people.
   4. 9. Let Testim^® 1% dry for a few minutes before you dress. This prevents your clothing from wiping the gel off your skin and ensures that your body will absorb the correct amount of testosterone.
   5. 10. Washing the application site up to 2 hours after application of Testim^® 1% can lower the amount of testosterone that is absorbed by your body, although levels should stay within the normal range. Therefore, you should wait at least two (2) hours after applying the gel before showering or swimming to ensure that the greatest amount of Testim^® 1% is absorbed into your body. On rare occasions, you may shower or swim as soon as one hour after applying Testim^® 1%. If done infrequently, this will have little effect on the amount of Testim^® 1% that is absorbed by your body.
   6. 11 If you expect that the area of skin to which you applied Testim^® 1% may come into direct skin contact with someone else, you should either thoroughly wash the application site with soap and water before that encounter or keep it covered with clothing. This will reduce the chance that the medicine will transfer to the other person.
   7. 12 The used tubes of Testim^® 1% should be discarded in household waste in a manner that prevents accidental exposure of children or pets.

What should I do if I get Testim^® 1% in my eyes?

If you get Testim^® 1% in your eyes, rinse your eyes right away with warm clean water to flush out any Testim^® 1%. Seek medical

IMPORTANT: PLEASE READ

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 immediately if you suspect an overdose.

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

What to do if someone else is exposed to the medication:

If someone else is exposed to Testim^® 1% 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 Testim^®1% with anyone.

Like all medicines, Testim^® 1% 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.

  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.

  This is not a complete list of side effects. For any unexpected effects while taking Testim^® 1%, contact your doctor or pharmacist.

HOW TO STORE IT

Store at Room Temperature (15°C – 30°C).

Keep in a safe place out of reach of children and pets.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html) 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

This document plus the full product monograph, prepared for health professionals can be found on 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://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636. This leaflet was prepared by Knight Therapeutics Inc. Last revised: JAN 16, 2026