TESTOSTERONE- testosterone gel, metered 
Actavis Pharma, Inc.

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MEDICATION GUIDE

Testosterone (tes-TOS-te-rone) CIII
Topical Gel

What is the most important information I should know about testosterone gel?

1. Testosterone gel can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone gel has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used testosterone gel.

Children

Signs and symptoms of early puberty in a child when they come in direct contact with testosterone gel may include:

Abnormal sexual changes:

  • enlarged penis or clitoris.
  • early growth of hair near the vagina or around the penis (pubic hair).
  • erections or acting out sexual urges (sex drive).

Behavior problems:

  • acting aggressively, behaving in an angry or violent way.

    Women

    Signs and symptoms in women when they come in direct contact with testosterone gel may

    include:

  • changes in body hair.
  • an abnormal increase in pimples (acne).

Stop using testosterone gel and call your healthcare provider right away if you see any signs and

symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied testosterone gel.

2. To lower the risk of transfer of testosterone gel from your body to others, follow these

important instructions:

  • Apply testosterone gel only to the front and inside area of your thighs that will be covered by clothing.
  • Wash your hands right away with soap and water after applying testosterone gel.
  • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a child or woman touches the area where you have applied testosterone gel, that area on the child or woman should be washed well with soap and water right away.

What is testosterone gel?

Testosterone gel is a prescription medicine that contains testosterone. Testosterone gel is used to treat adult males who have low or no testosterone due to certain medical conditions.

  • Your healthcare provider will test your blood before you start and while you are using testosterone gel.
  • It is not known if testosterone gel is safe or effective to treat men who have low testosterone due to aging.
  • It is not known if testosterone gel is safe or effective in children younger than 18 years old. Improper use of testosterone gel may affect bone growth in children.

Testosterone gel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel in a safe place to protect it. Never give testosterone gel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

Testosterone gel is not meant for use in women.

Do not use testosterone gel if you:

  • have breast cancer.
  • have or might have prostate cancer.
  • are pregnant or may become pregnant or breastfeeding. Testosterone gel may harm your unborn or breastfeeding baby.
  • Women who are pregnant or who may become pregnant should avoid contact with the area of skin where testosterone gel has been applied.

Before using testosterone gel, tell your healthcare provider about all of your medical conditions

including if you:

  • have breast cancer.
  • have or might have prostate cancer.
  • have urinary problems due to an enlarged prostate.
  • have heart problems.
  • have liver or kidney problems.
  • have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

Using testosterone gel with certain other medicines can affect each other. Especially, tell your healthcare

provider if you take:

  • insulin
  • medicines that decrease blood clotting (blood thinners)
  • corticosteroids

How should I use testosterone gel?

  • See the detailed Instructions for Use for information about how to use testosterone gel at the end of this Medication Guide.
  • It is important that you apply testosterone gel exactly as your healthcare provider tells you to.
  • Your healthcare provider may change your testosterone gel dose. Do not change your testosterone gel dose without talking to your healthcare provider.
  • Apply testosterone gel in the morning. If you shower or bathe, testosterone gel should be applied afterwards.

What are the possible side effects of testosterone gel?

Testosterone gel can cause serious side effects including:

See “What is the most important information I should know about testosterone gel?”

  • If you already have enlargement of your prostate gland your signs and symptoms can get worse while using testosterone gel. This can include:
    • increased urination at night.
    • trouble starting your urine stream.
    • having to pass urine many times during the day.
    • having an urge to go to the bathroom right away.
    • having a urine accident.
    • being unable to pass urine or weak urine flow.
  • Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use testosterone gel.
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses testosterone gel may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Have problems breathing while you sleep (sleep apnea).
  • Increased red blood cell count.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of testosterone gel include:

  • skin redness or irritation where testosterone gel is applied
  • increased in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer)
  • abnormal dreams

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of testosterone gel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.

How should I store testosterone gel?

  • Store testosterone gel at room temperature between 68º to 77ºF (20º to 25ºC).
  • When it is time to throw away the canister, safely throw away used testosterone gel in household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep testosterone gel away from fire.
  • Do not freeze testosterone gel.

Keep testosterone gel and all medicines out of the reach of children.

General information about testosterone gel

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use testosterone gel for a condition for which it was not prescribed. Do not give testosterone gel to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about testosterone gel that is written for health professionals.

What are the ingredients in testosterone gel?

Active ingredients: testosterone

Inactive ingredients: butylated hydroxytoluene, carbomer 1382, dehydrated alcohol, isopropyl alcohol, oleic acid, propylene glycol, purified water, and trolamine.

Manufactured by:

Actavis Laboratories UT, Inc.

Salt Lake City, UT 84108 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Rev. B 5/2019

For more information about testosterone gel, call 1-888-838-2872.

This Medication Guide has been approved by the U.S. Food and Drug Administration.             Revised: 05/2019


Revised: 5/2018
Actavis Pharma, Inc.