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IMPORTANT SAFETY INFORMATION
Signs of puberty that are not expected have been reported in young children who were accidentally exposed to testosterone through contact with men using AndroGel. AndroGel can transfer from the patient's body to others. This can happen if other people come into contact with the area where the AndroGel was applied. Women and children should avoid contact with the unwashed or unclothed application area where AndroGel has been applied. Patients must strictly follow the recommended instructions for use.
AndroGel must not be used in men with breast cancer. Also, AndroGel must not be used in men that have or might have prostate cancer. In addition, AndroGel must not be used in pregnant women, those who may become pregnant, or those who are breastfeeding, since testosterone can cause harm to the unborn or breast feeding baby. Patients should not use AndroGel if they are allergic to any of the ingredients in AndroGel, including soy. AndroGel is not approved for use in women.
To lower the risk of transfer of AndroGel, patients should apply AndroGel only to areas that will be covered by a short sleeve t-shift. These areas include shoulders, upper arms, and stomach area. Patients should wash their hands right away with soap and water after applying AndroGel. After the gel has dried, patients should cover the application area with clothing. If patients expect to have skin-to-skin contact with another person the patient should first wash the application area well with soap and water. If a woman or child makes contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away. The patient should stop using AndroGel and call their healthcare provider right away if they see any signs or symptoms in children or women that may have occurred through accidental exposure to AndroGel.
Other risks associated with the use of testosterone include prostate enlargement and prostate cancer.
The most common side effects reported with use of AndroGel 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.
AndroGel is approved for replacement therapy in adult males for conditions associated with low or absent testosterone in the body.
Please see full Prescribing Information including the Medication Guide.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report suspected adverse reactions to Solvay Pharmaceuticals, Inc. at 1-800-241-1643 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
© 2009 Solvay Pharmaceuticals, Inc.
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