AndroGel: Testosterone Gel

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AndroGel 1.62%
Safety FactsAndroGel 1%
Safety Facts
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  • IMPORTANT SAFETY FACTS

    • AndroGel 1.62% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1.62% was applied.
    • Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel 1.62%.
    • Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1.62% has been applied. If a woman or child makes contact with the AndroGel 1.62% application area, the contact area on the woman or child should be washed well with soap and water right away.
    • To lower the risk of transfer of AndroGel 1.62%, you should apply it only to your shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders or upper arms, first wash the application area well with soap and water.
    • Do not apply AndroGel 1.62% to any other parts of your body such as your stomach area (abdomen), penis, or scrotum.
    • Stop using AndroGel 1.62% and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel 1.62%.
    • Do not use AndroGel 1.62% if you have breast cancer or have or might have prostate cancer.
    • AndroGel 1.62% is not meant for use in women and must not be used in women who are or may become pregnant, or are breast-feeding. AndroGel 1.62% may harm the unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1.62% has been applied.
    • AndroGel 1.62% can cause serious side effects, including:
      • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel 1.62% (including changes in urination)
      • Possible increased risk of prostate cancer
      • In large doses, AndroGel 1.62% may lower your sperm count
      • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease
      • Enlarged or painful breasts
      • Having problems breathing while you sleep (sleep apnea)
      • Blood clots in the legs; this can include pain, swelling, or redness of your legs
    • Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids.
    • AndroGel 1.62% is flammable until dry. Let AndroGel 1.62% dry before smoking or going near an open flame.
    • The most common side effects of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied.
    • This is the most important information to know about AndroGel 1.62%. For further information, talk with your healthcare provider.

    Reference: 1. AndroGel 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • DO NOT USE if

    Do not use AndroGel 1.62% if you have breast cancer or have or might have prostate cancer.

    Do not use AndroGel 1.62% in women
    who are pregnant, who may become pregnant, or are breast-feeding, as AndroGel 1.62% may harm the unborn
    or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1.62% has been applied.

    AndroGel 1.62% is not meant for use in women.

    Reference: AndroGel 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • BEFORE USING AndroGel

    Before you use AndroGel 1.62%, tell your healthcare provider if you:

    • Have breast cancer
    • Have or might have prostate cancer
    • Have urinary problems due to an enlarged prostate
    • Have heart problems
    • Have kidney or liver problems
    • Have problems breathing while you sleep (sleep apnea)
    • Have any other medical conditions

    Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids.

    Reference: 1. AndroGel 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • SIDE EFFECTS

    AndroGel 1.62% can cause serious side effects, including:

    • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel 1.62% (including changes in urination)
    • Possible increased risk of prostate cancer
    • In large doses, AndroGel 1.62% may lower your sperm count
    • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease
    • Enlarged or painful breasts
    • Having problems breathing while you sleep (sleep apnea)
    • Blood clots in the legs; this can include pain, swelling, or redness of your legs

    The most common side effects of AndroGel 1.62% include increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where AndroGel 1.62% is applied.

    Reference: 1. AndroGel 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • USE

    AndroGel® (testosterone gel) 1.62% is a controlled substance, available by prescription, used to treat adult males who have low or no testosterone.

    It is not known if AndroGel 1.62% is safe or effective in children younger than 18 years old.

    Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

    Reference: AndroGel® 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • HOW TO USE AndroGel

    • It is important that you apply AndroGel 1.62% exactly as prescribed by your healthcare provider.
    • Your healthcare provider will tell you how much AndroGel 1.62% to apply and when to apply it.
    • Your healthcare provider may change your AndroGel 1.62% dose. Do not change your AndroGel 1.62% dose without talking to your healthcare provider.
    • AndroGel 1.62% is to be applied to the area of the shoulders and upper arms that will be covered by a short-sleeve T-shirt. Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum.
    • Apply AndroGel 1.62% at the same time each morning. AndroGel 1.62% should be applied after showering or bathing.
    • Wash your hands right away with soap and water after applying AndroGel 1.62%.
    • Let the application areas dry for a few minutes before putting on a shirt.
    • Avoid showering, swimming, or bathing for at least 2 hours after you apply AndroGel 1.62%.
    • AndroGel 1.62% is flammable until dry. Let AndroGel 1.62% dry before smoking or going near an open flame.

    Reference: 1. AndroGel 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

  • HELPFUL RESOURCES

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

    If you cannot afford your medication, contact www.pparx.org or call the toll free number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

    Reference: AndroGel® 1.62% [package insert].

    Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1.62%.

Use

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.

It is not known if AndroGel is safe or effective in children younger than 18 years old.

Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

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*Certain restrictions apply. Offer not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicare, Medicaid, any other federal or state program, or by private plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. Offer void where otherwise prohibited by law. See complete Terms and Conditions section.

Terms and Conditions

Offer not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicare, Medicaid, any other federal or state program, or by private plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. You must deduct the value of this offer from any reimbursement requests submitted to your insurance plan either by you or on your behalf. Offer void where otherwise prohibited by law. Offer good only in USA. Co-pay Card limited to one per person during offering period and is not transferable. Offer limited to one use per month up to 12 times per patient. Offer expires 12/31/13. AbbVie reserves the right to terminate this offer at any time without notice. You understand and agree to comply with these Offer Terms.

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