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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:

• Apply AXIRON only to your armpits.
• Wash your hands right away with soap and water after applying AXIRON.
• After the solution has dried, cover the application area with clothing. Keep area covered until you have washed the application area well or have showered.
• If you expect another person to have direct skin-to-skin contact with your armpits, first wash the application area well with soap and water.

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:

• have or might have prostate cancer
• have breast cancer
• are pregnant or may become pregnant or are breast-feeding. AXIRON may harm your unborn or breast-feeding baby.

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:

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

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:

• insulin
• medicines that decrease blood clotting
• corticosteroids

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:

• If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AXIRON. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine or weak urine flow.
• Possible increased risk of prostate cancer. Your healthcare provider should check for prostate cancer or any other prostate problems before you start and while you use AXIRON.
• In large doses AXIRON may lower your sperm count.
• Swelling of your ankles, feet, or body.
• Enlarged or painful breasts.
• Problems breathing while you sleep (sleep apnea).
• 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.

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.

For more information, please see full Prescribing Information, including Boxed Warning regarding the risk of transfer to others, and Medication Guide.

TS CON ISI 10JUL2014