When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to enzalutamide. Women should not use this medicine, especially women who are pregnant or able to become pregnant.

How to Use This Medicine:
Liquid Filled Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take it at the same time each day.
• Swallow the capsule whole. Do not chew, dissolve, or open it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how enzalutamide works. Tell your doctor if you are using alfentanil, bosentan, carbamazepine, cyclosporine, dihydroergotamine, efavirenz, ergotamine, etravirine, fentanyl, gemfibrozil, itraconazole, midazolam, modafinil, nafcillin, omeprazole, phenobarbital, phenytoin, pimozide, quinidine, rifabutin, rifampin, rifapentine, sirolimus, St John's wort, tacrolimus, or warfarin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. You must use a condom together with a second form of birth control while you use this medicine and for 3 months after the last dose.
• Tell your doctor if you have a history of a brain injury or tumor, seizures, or a stroke.
• This medicine may cause the following problems:
  
  • Seizures
  • Posterior reversible encephalopathy syndrome (PRES)
• This medicine may cause dizziness, tiredness, muscle weakness, or seizures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Headache, confusion, unusual drowsiness, tiredness, weakness, feeling of sluggishness, or blurred vision
• Seizures

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088