XTANDI may cause serious side effects

Important Safety Information

What should I tell my doctor before taking XTANDI?

Tell your doctor about all your medical conditions, including if you:

• Have a history of seizures, brain injury, stroke, or brain tumors.
• Have a history of heart disease, have high blood pressure, or have abnormal amounts of fat or cholesterol in your blood (dyslipidemia).
• Are pregnant or plan to become pregnant. XTANDI can cause harm to your unborn baby and loss of pregnancy (miscarriage).
• Have a partner who is pregnant or may become pregnant.
  • Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with XTANDI and for 3 months after the last dose.
  • Males must use a condom during sex with a pregnant female.
• Are breastfeeding or plan to breastfeed. It is not known if XTANDI passes into your breast milk.
• Take other medicines.
  XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. These include prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start or stop any medicine without talking to your doctor.

How should I take XTANDI?

• Take XTANDI exactly as your doctor tells you. Take your prescribed dose once a day, at the same time each day. XTANDI can be taken with or without food. Swallow XTANDI capsules or tablets whole. Do not chew, dissolve, or open the capsules. Do not cut, crush or chew the tablets. Your doctor may change your dose if needed.
• Do not change or stop taking your prescribed dose of XTANDI without talking with your doctor first.
• If you are receiving gonadotropin-releasing hormone (GnRH) therapy, you should continue with this treatment while taking XTANDI unless you have had surgery to lower the amount of testosterone in your body (surgical castration).
• 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 each day.
• If you take too much XTANDI: Call your doctor 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?

XTANDI may cause serious side effects including:

• Seizure. If you take XTANDI, you may be at risk of having a seizure. Avoid activities where a sudden loss of consciousness could seriously harm you or someone else. Tell your doctor right away if you lose consciousness or have a seizure.
• Posterior Reversible Encephalopathy Syndrome (PRES). If you take XTANDI you may be at risk of developing a condition involving the brain called PRES. Tell your doctor right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your doctor will do a test to check for PRES.
• Allergic Reactions. Allergic reactions have happened in people who take XTANDI. Stop taking XTANDI and get medical help right away if you develop swelling of the face, tongue, lip or throat.
• Heart Disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with XTANDI. Your doctor will monitor you for signs and symptoms of heart problems during your treatment. Call your doctor or go to the emergency room right away if you get chest pain or discomfort at rest or with activity or shortness of breath during your treatment with XTANDI.
• Falls and Fractures. XTANDI treatment may increase your risk for falls and fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and fractures during treatment with XTANDI.

Your doctor will stop treatment with XTANDI if you have serious side effects.

The most common side effects of XTANDI include:

• Weakness or feeling more tired than usual
• Back pain
• Hot flashes
• Constipation
• Joint pain
• Decreased appetite
• Diarrhea
• High blood pressure

XTANDI may cause fertility problems in males, which may affect the ability to father children. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of XTANDI. For more information, talk to your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For further information, please talk to your doctor and click here for Patient Information and Full Prescribing Information for XTANDI.