PRESCRIBING INFORMATION

If you have any questions about this information, be sure to discuss them with your doctor.

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.

USE AND IMPORTANT SAFETY INFORMATION

USE 1,2

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

It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

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

AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION 1,2

USE AND IMPORTANT SAFETY INFORMATION 1,2

USE 1,2

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

It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

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

AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION 1,2

• AndroGel can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the AndroGel was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where AndroGel 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 AndroGel.
• Signs and symptoms of early puberty in a child who has come in direct contact with AndroGel 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).
    • Changes in body hair.
    • An abnormal increase in pimples (acne).
    • Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
    • Apply AndroGel 1% only to areas of your shoulders, upper arms, or stomach area (abdomen) that will be covered by a short-sleeve t-shirt.
    • Wash your hands right away with soap and water after applying AndroGel.
    • 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 AndroGel, that area on the child or woman should be washed well with soap and water right away.
    • Have breast cancer or have or might have prostate cancer.
    • Are pregnant. AndroGel may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.
    • If you already have an enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination).
    • Possible increased risk of prostate cancer.
    • 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, AndroGel 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).

    Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

    Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

    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.

    The information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made by a healthcare provider considering the unique characteristics of the patient. This site is intended for US residents only. Use of and access to this site are subject to the Terms of Use and Privacy Statement.

    Reference: 1. AndroGel 1.62% [package insert]. ASCEND Therapeutics US, LLC, Morristown, NJ. 2022 2. AndroGel 1% [package insert]. ASCEND Therapeutics US, LLC, Morristown, NJ, 2022.

    USE AND IMPORTANT SAFETY INFORMATION

    USE 1,2

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

    It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

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

    AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

    AndroGel is not meant for use in women.

    IMPORTANT SAFETY INFORMATION 1,2

    USE AND IMPORTANT SAFETY INFORMATION 1,2

    USE 1,2

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

    It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

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

    AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

    AndroGel is not meant for use in women.

    IMPORTANT SAFETY INFORMATION 1,2

    • AndroGel can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the AndroGel was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where AndroGel 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 AndroGel.
    • Signs and symptoms of early puberty in a child who has come in direct contact with AndroGel 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).
        • Changes in body hair.
        • An abnormal increase in pimples (acne).
        • Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
        • Apply AndroGel 1% only to areas of your shoulders, upper arms, or stomach area (abdomen) that will be covered by a short-sleeve t-shirt.
        • Wash your hands right away with soap and water after applying AndroGel.
        • 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 AndroGel, that area on the child or woman should be washed well with soap and water right away.
        • Have breast cancer or have or might have prostate cancer.
        • Are pregnant. AndroGel may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.
        • If you already have an enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination).
        • Possible increased risk of prostate cancer.
        • 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, AndroGel 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).

        Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

        Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

        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.

        The information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made by a healthcare provider considering the unique characteristics of the patient. This site is intended for US residents only. Use of and access to this site are subject to the Terms of Use and Privacy Statement.

        Important Safety Information
        for Patients