Read this Patient Information before you start taking XTANDI and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is XTANDI?

XTANDI is a prescription medicine used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body and who have received treatment with docetaxel.

It is not known if XTANDI is safe and effective in children.

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.

What should I tell my healthcare provider before taking XTANDI?

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 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?”

Tell your healthcare provider about all the medicines you take, 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. Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.

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?

XTANDI may cause serious side effects including:

• Seizure. Some people have had seizures during treatment with XTANDI. 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
• 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.

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

How should I store XTANDI?

• Store XTANDI between 68°F to 77°F (20°C to 25°C).
• Keep XTANDI capsules dry and in a tightly closed container.

Keep XTANDI and all medicines out of the reach of children.

General information about XTANDI

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XTANDI for a condition for which it was not prescribed. Do not give XTANDI to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about XTANDI. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about XTANDI that is written for healthcare professionals.

For more information go to www.AboutXtandi.com or call 1-800-727-7003.

What are the ingredients in XTANDI?

Active ingredient: enzalutamide Inactive ingredients: caprylocaproyl polyoxylglycerides , butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, black iron oxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716

Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation Inc., San Francisco, CA 94105

Issued: August 2012 12A005-ENZ

© 2012 Astellas Pharma US, Inc.

XTANDI® is a trademark of Astellas Pharma Inc.