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 can 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 or 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 your 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 over-the-counter medicines, vitamins, and herbal supplements. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. 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 exactly as your healthcare provider tells you.
• Take your prescribed dose of XTANDI one time a day, at the same time each day.
• Your healthcare provider may change your dose if needed.
• Do not change or stop taking your prescribed dose of XTANDI without talking with your healthcare provider first.
• XTANDI 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 in one day.
• If you take too much XTANDI, call your healthcare provider or go to the nearest emergency room right away. You may have an increased risk of seizure if you take too much XTANDI.

What are the possible side effects of XTANDI?

• Seizure. 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. Your healthcare provider will stop XTANDI if you have a seizure during treatment.

The most common side effects of XTANDI include weakness or feeling more tired than usual, back pain, decreased appetite, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet, shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and a feeling that you or things around you are moving or spinning (vertigo).

XTANDI may cause infections, falls and injuries from falls. Tell your healthcare provider if you have signs or symptoms of an infection or if you fall.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the Full Prescribing Information for complete safety information.