Enzalutamide is a prescription medicine used to treat prostate cancer in men who have received surgery or hormone therapy to lower testosterone.

Enzalutamide is sometimes used when the cancer no longer responds to treatment, but has not spread to other parts of the body.

Enzalutamide is also used when the cancer has responded to treatment and has spread to other parts of the body (metastatic).

It is not known if enzalutamide is safe and effective in children or females.

Although not for use by women, enzalutamide can cause birth defects if the mother or the father is taking this medicine. Use a condom and one other form of birth control to prevent pregnancy while using this medicine, and for at least 3 months after your last dose.

Take enzalutamide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take the medicine at the same time each day, with or without food.

You may need to take 2 to 4 tablets at a time to get a full dose.

Swallow the enzalutamide pill whole. Do not break, chew, or crush a tablet. Do do not chew, open, or dissolve a capsule.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Prostate Cancer:

160 mg (four 40 mg capsules) orally once a day

Comments:
-This drug can be taken with or without food.
-Swallow capsules whole. Do not chew, dissolve, or open the capsules.
-Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Use: Metastatic and non-metastatic castration-resistant prostate cancer

You should not use enzalutamide if you are allergic to it.

To make sure enzalutamide is safe for you, tell your doctor if you have ever had:

• a seizure;

• a head injury, stroke, or brain tumor;

• heart disease, circulation problems;

• high blood pressure;

• diabetes; or

• high cholesterol or triglycerides (a type of fat in the blood).

Enzalutamide can harm an unborn baby or cause birth defects, even if the father is taking this medicine.

• If your sex partner is pregnant, always use a condom during sex.

• If your sex partner could become pregnant, use effective birth control to prevent pregnancy. Keep using birth control for at least 3 months after you stop taking enzalutamide.

• Tell your doctor at once if a pregnancy occurs while you are taking this morning.

Although this medicine is not for use by women, enzalutamide should not be taken by a woman who is breastfeeding a baby.

Take the missed dose as soon as you remember. If you forget your dose for the entire day, skip the missed dose and go back to your regular schedule the next day. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose could cause you to have a seizure.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Enzalutamide can increase your risk of seizure. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Avoid driving or hazardous activity until you know how enzalutamide will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Even without dizziness, taking enzalutamide could increase your risk of falls or bone fractures. Avoid activities or situations that may lead to injury or falls.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to enzalutamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using enzalutamide and call your doctor at once if you have:

• dizziness, spinning sensation;

• a seizure (black-out or convulsions);

• confusion, thinking problems, severe headache, vision problems;

• weakness, loss of consciousness;

• red or pink urine;

• heart problems - chest pain, shortness of breath (even with mild exertion);

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

• signs of a lung infection - fever, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common enzalutamide side effects may include:

• feeling weak or tired;

• constipation, diarrhea;

• loss of appetite;

• flushing (redness, hot feeling);

• back pain, joint pain; or

• high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Enzalutamide can increase your risk of having a seizure, especially if you also use certain other medicines for infections, swelling or inflammation, asthma, hormone replacement, diabetes, depression, or mental illness.

Many drugs can interact with enzalutamide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.