Enzalutamide Oral capsule, liquid filled

What is this medicine?

ENZALUTAMIDE blocks the effect of the male hormone called testosterone. This medicine is used for certain types of prostate cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• brain tumor

• head injury

• history of stroke

• seizures

• an unusual or allergic reaction to enzalutamide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. You can take it with or without food. If it upsets your stomach, take it with food. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose and skip your missed dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• alfentanil

• bosentan

• certain medications for seizures like carbamazepine, phenobarbital, and phenytoin

• cyclosporine

• dihydroergotamine

• efavirenz

• ergotamine

• etravirine

• fentanyl

• gemfibrozil

• midazolam

• modafinil

• nafcillin

• omeprazole

• pimozide

• quinidine

• rifabutin

• rifampin

• rifapentine

• St. John’s Wort

• sirolimus

• tacrolimus

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine should not be used in women. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Due to a risk of seizures with enzalutamide therapy, use caution when engaging in activities that could result in serious harm to yourself or others if you pass out.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• confusion

• falls

• loss of memory

• seizures

• sudden numbness or weakness of the face, arm or leg

• trouble speaking or understanding

• trouble walking, dizziness, loss of balance or coordination

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• blood in the urine

• breathing problems

• diarrhea

• dizziness

• headache

• joint pain

• pain, tingling, numbness in the hands or feet

• swelling of the ankles, feet, hands

• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.