Androgel: Uses, Side Effects and Dosage

What is ANDROGEL used for?

• ANDROGEL is used in adult males as testosterone replacement therapy when your body is not making enough testosterone. The medical term for this condition is hypogonadism. Your healthcare professional will confirm you have this condition by doing two separate blood testosterone measurements.

How does ANDROGEL work?

ANDROGEL contains the medicinal ingredient testosterone. It delivers the medicine into your bloodstream after being applied your skin. This helps raise your testosterone to normal levels.

What are the ingredients in ANDROGEL?

Medicinal ingredients: testosterone

Non-medicinal ingredients: alcohol, carbopol 980, isopropyl myristate, purified water, sodium hydroxide

Serious Warnings and Precautions

Secondary exposure to testosterone: ANDROGEL can be transferred from you to another person if there is skin-to-skin contact with the location you applied ANDROGEL.

• You must follow the instructions for using ANDROGEL carefully to lower the risk of transferring it to another person (see How to use ANDROGEL).
• If a child has skin contact with your unwashed or unclothed ANDROGEL application sites, or with clothing or other fabrics (such as sheets or towels) exposed to ANDROGEL, they should immediately wash the area of contact with soap and water.
• Signs of puberty (unexpected sexual development) have been reported in children who were exposed to testosterone gel. This includes inappropriate enlargement of the penis or clitoris, growth of facial or body hair, increased erections, aggressive behaviour, deepening of the voice and accelerated height.
• If any of these changes are seen in children who may have come into contact with ANDROGEL talk to your healthcare professional immediately.

ANDROGEL comes in the following dosage forms:

Gel; 1% testosterone

Do not use ANDROGEL if:

• you are allergic to testosterone, which may be synthesized from soy, or any of the non-medicinal ingredients in ANDROGEL (see “What are the ingredients in ANDROGEL?”)
• you have, or are suspected of having, prostate or breast cancer

ANDROGEL should NOT be used by women.

• In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, changes in the menstrual cycle and signs of the development of masculine traits.
• Pregnant and breast feeding women are especially at risk and should avoid skin contact with ANDROGEL application sites on men. Testosterone may cause harm to their unborn or breastfeeding baby. Testosterone exposure during pregnancy has been reported to be associated with birth defects. If your partner becomes pregnant, or is breastfeeding, you must follow the instructions for use carefully to avoid transfer of ANDROGEL (see How to use ANDROGEL).
• If a woman has skin contact with your unwashed or unclothed ANDROGEL application sites or with clothing or other fabrics (such as sheets or towels) exposed to ANDROGEL they should immediately wash the area of contact with soap and water.

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

• have or have a family history of, prostate problems, including difficulty urinating due to an enlarged prostate
• have cancer in your bones
• have liver or kidney problems
• have high blood pressure (hypertension)
• have epilepsy or a history of seizures (fits)
• have a history of migraine headaches
• have diabetes
• have breathing problems during sleep (sleep apnea), or risk factors for developing sleep apnea such as obesity or lung problems
• have heart or blood vessel problems or a history of heart attack, stroke, or heart failure

• have a blood clotting disorder, have had a blood clot or have risk factors for developing a blood clot:

  • smoking
  • obesity
  • cancer
  • immobility (such as during a prolonged illness or after surgery);
  • family history of blood clots in the arm, leg, lung or other organs
• are over 65 years of age. You may have a higher risk of having urinary side effects or developing an enlarged prostate or prostate cancer.

Other warnings you should know about:

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

Blood tests and monitoring:

• Your healthcare professional will check your blood testosterone levels before you start using ANDROGEL. They will continue to check them regularly while you are being treated with ANDROGEL to make sure you are taking the correct dose.
• ANDROGEL can cause abnormal blood test results. This includes changes to your red blood cell counts, PSA (prostate-specific antigen) levels, liver function and lipid profile. Your healthcare professional will decide when to perform blood tests and will interpret the results.
• Your healthcare professional may also monitor the health of your prostate gland by performing digital rectal examinations.

Fertility: ANDROGEL can affect your fertility by affecting your testicles and your sperm. It can make you unable to father a child.

• ANDROGEL can cause testicular atrophy which is a reduction in the size of your testicles.
• ANDROGEL can affect your sperm production, reducing your sperm count, or cause you to stop making sperm.
• ANDROGEL is not to be used to treat sexual dysfunction or male infertility.

Drug Abuse and Dependence: ANDROGEL contains testosterone, which is a controlled substance. You should not use ANDROGEL in an attempt to improve body composition (i.e. reduce weight and increase muscle) or improve athletic performance as it may cause serious health problems.

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 ANDROGEL:

• insulin and other medicine used to treat diabetes
• corticosteroids, used to treat inflammation and suppress the immune system
• propranolol, used to treat high blood pressure and other heart problems
• medicines used to thin the blood and prevent blood clots, such as warfarin
• the herbal medicine St. John’s wort (hypericum perforatum), used to treat depression

How to use ANDROGEL:

1. 1. Apply ANDROGEL at the same time each day (preferably in the morning). Apply the prescribed amount of gel every morning as instructed by your healthcare professional. The amount of ANDROGEL you need may be adjusted by your healthcare professional during treatment. Always follow your healthcare professional’s recommendations. You should be applying the gel yourself to avoid other people coming into contact with the gel.
2. 2. Be sure your skin is completely dry before applying ANDROGEL. If you take a bath or shower in the morning, apply ANDROGEL after your bath or shower, once your skin is completely dry.
3. 3. 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.
• Only apply ANDROGEL to healthy, normal skin. ANDROGEL contains alcohol which may cause a burning sensation if it is applied to damaged skin. Avoid skin with open sores, wounds, sunburn, or irritation.
• Wash your hands immediately after 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 you get ANDROGEL in your eyes, rinse your eyes right away with warm, clean water to flush out the gel. Get medical attention if you still have discomfort after rinsing the eyes thoroughly.
• If you expect to have direct skin contact with someone else after applying ANDROGEL you must wait at least 1 hour. After the hour has passed you must wash your application site(s) with soap and water before having any direct skin contact. 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 the gel or wiping the gel off your skin, ensuring that your body will absorb the correct amount of testosterone.
• Once the gel has dried, cover the application site with clean clothing. You can prevent transferring ANDROGEL to other people by covering the application site with a long-sleeved shirt (cotton-polyester blend).
• Allow the gel to dry completely before smoking or going near an open flame. ANDROGEL contains alcohol which is flammable.
• Wait 1 hour before showering or swimming. To ensure that ANDROGEL is fully absorbed into your system, you should wait one hour after application before showering or swimming.
• 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

1. i)

   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 the gel down the sink or discarding it in the household trash in a manner that prevents accidental application or ingestion by household members, especially children and breast feeding or pregnant women.

ii) 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 healthcare professional:

Prescribed Daily Dose

Number of Full Pump Depressions

5 g

4

7.5 g

6

10 g

8

iii) 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.

Prescribed Daily Dose

Number of Days of Treatment per Pump

(after priming)

5 g

15

7.5 g

10

10 g

7.5

iv) Applying ANDROGEL to your skin:

Fully press the pump the appropriate number of times to deliver the daily dose prescribed by your healthcare professional. 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 your daily dose. Alternatively, the gel can be applied directly to the application sites. Application directly to the sites may prevent loss of the medicine that can occur during transfer from the palm of your hand onto the application sites.

Section B: Using the ANDROGEL packet

1. i)

   Opening the packet:

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

ii) 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 above (see How to use ANDROGEL). Use a circular motion to rub in the gel for several seconds. Once you have applied this first half of the gel in the packet 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 children and breast feeding and pregnant women.
• After opening the packet, the entire contents should be squeezed out and applied immediately onto your skin.

Usual dose:

The recommended starting dose of ANDROGEL is 5 g (to deliver 50 mg of testosterone). This is provided by either:

• 4 pump actuations, or
• two 25 mg packets, or
• one 50 mg packet

Overdose:

If you use more ANDROGEL than your recommended dose, wash the skin with soap and water where ANDROGEL was applied and talk to your healthcare professional.

If you think you, or a person you are caring for, have used too much ANDROGEL, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

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 the 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.

Missed Dose:

If you missed a dose of this medication and it is more than 12 hours until your next dose, take the dose that you missed as soon as you remember. If your next dose is less than 12 hours away skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not use two doses at the same time.

What are possible side effects from using ANDROGEL?

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

Side effects may include:

• skin irritation, redness or rash at the application site
• change in frequency of erections
• testicular atrophy (reduction in testicle size)
• change in libido
• hot flashes
• sweating
• hair loss, baldness
• dandruff
• acne
• dry skin, itching
• sleep disturbances (insomnia)
• sleep apnea (trouble breathing when sleeping)
• lack of energy
• headaches
• dizziness
• weight gain
• diarrhea, nausea
• muscle cramps
• numbness and tingling

Serious side effects and what to do about them

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

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 (canada.ca/drug-device-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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store ANDROGEL at room temperature (15 - 30°C).

Keep out of reach and sight of children and pets.

If you want more information about ANDROGEL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.viatris.ca, or by calling 1-844-596-9526.

Date of Authorization: AUG 01, 2025

®Registered Trademark Abbott Laboratories (USA) Licensed use by BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6