XTANDI

Important Safety Information

Who should not take XTANDI?

XTANDI is not for use in women. Do not take XTANDI if you are pregnant or may become pregnant. XTANDI may harm your unborn baby. It is not known if XTANDI is safe and effective in children.

Before you take XTANDI, tell your healthcare provider if you:

• Have a history of seizures, brain injury, stroke, brain tumors.
• Have any other medical conditions.
• Have a partner who is pregnant or plans to become pregnant. Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with XTANDI. If their sexual partner may become pregnant, a condom and another form of birth control must be used during and for 3 months after treatment. Talk with your healthcare provider if you have questions about birth control. See “Who should not take XTANDI?”
• Take any other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements. XTANDI can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed XTANDI.

How should I take XTANDI?

• Take XTANDI capsules exactly as your healthcare provider tells you.
• Take your prescribed dose of XTANDI one time a day.
• Your healthcare provider may change your dose if needed.
• Do not stop taking your prescribed dose of XTANDI without talking with your healthcare provider first.
• XTANDI capsules can be taken with or without food.
• Swallow XTANDI capsules whole. Do not chew, dissolve, or open the capsules.
• If you miss a dose of XTANDI, take your prescribed dose as soon as you remember that day. If you miss your daily dose, take your prescribed dose at your regular time the next day. Do not take more than your prescribed dose of XTANDI.
• If you take too much XTANDI, call your healthcare provider or go to the nearest emergency room right away.

What are the possible side effects of XTANDI?

• Seizure. Some people have had seizures during treatment with XTANDI (7 of 800 in a clinical trial). If you take XTANDI you may be at risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure.

The most common side effects of XTANDI include weakness or feeling more tired than usual, back pain, diarrhea, pain in your joints, hot flashes, swelling in your hands, arms, legs or feet, muscle or bone pain, headache, cold like symptoms, muscle weakness, dizziness, trouble falling or staying asleep (insomnia), trouble breathing (pneumonia), back pain with nerve problems in the lower body, including leg numbness or weakness, pink or red urine (hematuria), sensation of tingling, burning, pricking, or numbness of skin (paresthesia), anxiety, and high blood pressure (hypertension).

Tell your healthcare provider if you have any falls or problems thinking clearly. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XTANDI. For more information, ask your healthcare provider or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information for complete safety information.