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IMPORTANT SAFETY FACTS
- AndroGel 1% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1% 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%.
- Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied. If a woman or child makes contact with the AndroGel 1% 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%, you should apply it only to your shoulders, upper arms, and/or stomach (abdomen), 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, upper arms, or stomach, first wash the application area well with soap and water.
- Do not apply AndroGel 1% to any other parts of your body, such as your penis, scrotum, chest, or back.
- Stop using AndroGel 1% and call your healthcare provider right away if you see any signs or 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%.
- Do not use AndroGel 1% if you have breast cancer or have or might have prostate cancer.
- AndroGel 1% is not meant for use in women and must not be used in women who are pregnant, may become pregnant, or are breastfeeding. AndroGel 1% may harm the unborn or breastfeeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1% has been applied.
- AndroGel 1% 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% (including changes in urination)
- Possible increased risk of prostate cancer
- In large doses, AndroGel 1% 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 in 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% is flammable until dry. Let AndroGel 1% dry before smoking or going near an open flame.
- The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen (a test used to screen for prostate cancer), increased red blood cell count, and increased liver function tests.
- This is the most important information to know about AndroGel 1%. For further information, talk with your healthcare provider.
Reference: AndroGel® 1% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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DO NOT USE if
Do not use AndroGel 1% if you have breast
cancer, or if you have or might have prostate cancer.
Do not use AndroGel 1% in women who are
pregnant, who may become pregnant, or are breast-feeding as AndroGel 1% 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% has been applied.
Reference: AndroGel® 1% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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BEFORE USING AndroGel 1%
Before you use AndroGel 1%, tell your healthcare provider if you:
- Have breast cancer or 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)
- Have any other medical conditions
Tell your healthcare provider about all the
medicines you take, especially if you take insulin, corticosteroids, or
medicines that decrease blood clotting.
Reference: AndroGel® 1% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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SIDE EFFECTS
AndroGel 1% 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% (including changes in urination)
- Possible increased risk of prostate cancer
- In large doses, AndroGel 1% 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 male 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 reported with use of AndroGel 1% are acne, skin irritation where the gel
is applied, increased cholesterol levels, increased prostate specific
antigen, increased red blood cell count, and increased liver function
tests.
Reference: AndroGel® 1% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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USE
AndroGel® (testosterone gel) 1% 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% 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% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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HOW TO USE AndroGel 1%
- It is important that you apply AndroGel 1%
exactly as prescribed by your healthcare provider. Your healthcare
provider will tell you how much AndroGel 1% to apply and when to apply it.
- Your healthcare provider may change your
AndroGel 1% dose. Do not change your AndroGel 1% dose without talking to your
healthcare provider.
- AndroGel 1% is for skin use only.
- Do not allow others to apply AndroGel 1% to your body.
Apply AndroGel 1% only to areas that
will be covered by a short sleeve T-shirt. These areas are your
shoulders and upper arms, or stomach area, or shoulders, upper arm and
stomach area.
Do not apply AndroGel 1% to your penis or scrotum.
Wash your hands with soap and water right after you apply AndroGel 1%.
Let the application areas dry for a few minutes before putting on a shirt.
To prevent transfer of AndroGel 1% to others, clothes (such as a T-shirt) should always be worn to cover the AndroGel 1% application areas until you have washed the application areas well with soap and water.
AndroGel 1% is flammable until dry. Let the gel dry before smoking or going near an open flame.
Reference: AndroGel® 1% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.
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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% [package insert].
Click to view full Prescribing Information, including the Medication Guide, for AndroGel 1%.