enzalutamide (Xtandi)

Brand Names: Xtandi

Generic Name: enzalutamide

• What is enzalutamide (Xtandi)?
• What are the possible side effects of enzalutamide (Xtandi)?
• What is the most important information I should know about enzalutamide (Xtandi)?
• What should I discuss with my healthcare provider before taking enzalutamide (Xtandi)?
• How should I take enzalutamide (Xtandi)?
• What happens if I miss a dose (Xtandi)?
• What happens if I overdose (Xtandi)?
• What should I avoid while taking enzalutamide (Xtandi)?
• What other drugs will affect enzalutamide (Xtandi)?
• Where can I get more information (Xtandi)?

Enzalutamide is used to treat prostate cancer when surgery or other medicines have not worked or have stopped working.

Enzalutamide is also used to treat prostate cancer that has spread to other parts of the body (metastatic).

Enzalutamide may also be used for purposes not listed in this medication guide.

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capsule, white, imprinted with ENZ

Get emergency medical help if you have signs of an allergic reaction: 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 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.

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.

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

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 you are taking enzalutamide and your sex partner could become pregnant, use effective birth control to prevent pregnancy. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor at once if a pregnancy occurs while you are taking enzalutamide.

Enzalutamide capsules should not be handled by a woman who is pregnant or who may become pregnant.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Swallow the capsule whole and do not chew, open, or dissolve it.

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. Do not allow another person to handle your medicine.

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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.

This medication can make you dizzy, and may cause you to have a seizure or suddenly become unconscious. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness can cause falls, accidents, bone fractures, 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.

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 affect 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.

Your pharmacist can provide more information about enzalutamide.

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