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IMPORTANT SAFETY INFORMATION FOR AXIRON (TESTOSTERONE) TOPICAL SOLUTION
What is the most important information I should know about AXIRON?
AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the AXIRON was applied. Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through skin to skin contact with men using topical testosterone products like AXIRON. Women and children should avoid contact with the unwashed or unclothed area where AXIRON has been applied. If a woman or child makes contact with the 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 AXIRON from your body to others, follow these important instructions:
Stop using AXIRON and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AXIRON. Signs and symptoms in children may include enlarged penis or clitoris; early development of pubic hair; increased erections or sex drive; aggressive behavior. Signs and symptoms in women may include changes in body hair and a large increase in acne.
Who should not use AXIRON?
Do not use AXIRON if you:
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AXIRON has been applied.
What should I tell my healthcare provider before using AXIRON?
Before you use AXIRON, tell your healthcare provider if you have:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using AXIRON with other medicines can affect each other. Especially, tell your healthcare provider if you take:
What are the possible side effects of AXIRON?
AXIRON can cause serious side effects. Call your healthcare provider right away if you have any of the following:
The most common adverse events include: skin redness or irritation where AXIRON is applied, increased red blood cell count, headache, diarrhea, vomiting, and increase in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer). Other side effects include more erections than are normal for you or erections that last a long time.
AXIRON is flammable until dry. Let AXIRON dry before smoking or going near an open flame.
Axiron is available by prescription only
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.
TS Axiron CON ISI, 10AUG2011 PV8160
If you have additional questions about AXIRON, call 1-800-545-5979. This toll-free number will connect you with a healthcare professional who can provide additional information. This is an information service. It is not meant to replace your healthcare professional’s advice. Your own healthcare professional is the best source of information regarding your health.
If you have a medical emergency, call your emergency telephone hotline (usually 911). For non-urgent medical advice, please contact your healthcare professional.
AXIRON is used to treat adult males who have low or no testosterone. AXIRON is not intended for use in women or anyone under 18 years of age. It is not known if AXIRON is safe and effective in children younger than 18 years old. Improper use of AXIRON may affect bone growth in children.