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Pronunciation: ENZ a LOOT a mide

Brand: Xtandi

What is the most important information I should know about enzalutamide?

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 during your treatment, and for at least 3 months after your treatment ends.

What is enzalutamide?

Enzalutamide is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Enzalutamide is used to treat prostate cancer.

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

What should I discuss with my healthcare provider before taking enzalutamide?

Enzalutamide can increase your risk of having a seizure. To make sure this medicine is safe for you, tell your doctor if you have:

  • epilepsy or other seizure disorder; or
  • a recent head injury, stroke, or brain tumor (in the past 12 months).

Although not for use by women, enzalutamide can cause birth defects if the mother or the father is taking this medicine. Do not use enzalutamide if you are pregnant.

If you are taking enzalutamide and your sexual partner could become pregnant, use a condom and one other form of birth control to prevent pregnancy during treatment. Keep using these birth control methods for at least 3 months after your treatment ends. Tell your doctor at once if a pregnancy occurs while either parent is being treated with enzalutamide.

Although this medicine is not for use by women, it is not known whether enzalutamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take enzalutamide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take enzalutamide with or without food. Take the medicine at the same time each day.

Do not crush, break, or dissolve an enzalutamide capsule. Swallow it whole.

Prostate cancer is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice.

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

What happens if I miss a dose?

Take the missed dose if you remember it later in the day. Skip the missed dose if it is almost time for your next day's dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking enzalutamide?

This medication can make you dizzy, and may cause you to have a seizure or suddenly become unconscious. Be careful if you drive or do anything that requires you to be alert.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of enzalutamide?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Enzalutamide may cause side effects on your spinal cord. Stop taking this medicine and call your doctor at once if you have:

  • severe low back pain, pain or weakness in your lower body;
  • trouble walking or standing up;
  • severe and worsening numbness or tingling; or
  • sudden loss of bladder or bowel control.

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

  • a seizure (black-out or convulsions);
  • red or pink urine;
  • signs of a lung infection --fever, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath; or
  • signs of swelling in your brain --severe headache, buzzing in your ears, vision problems, lack of energy, confusion, weakness.

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

Common side effects may include:

  • headache, dizziness, spinning sensation;
  • feeling short of breath, feeling weak or tired;
  • increased blood pressure (severe headache, blurred vision, pounding in your neck or ears);
  • numbness, burning pain, or prickly feeling under your skin;
  • flushing (warmth, redness, hot feeling);
  • back pain, joint or muscle pain, bone pain;
  • swelling in your arms or legs;
  • loss of appetite, weight loss;
  • diarrhea, constipation; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

What other drugs will affect enzalutamide?

Enzalutamide can increase your risk of having a seizure. This effect may be more likely if you also use certain other medicines that increase seizure risk. Tell your doctor if you are using an antibiotic, an antidepressant, asthma medication (a bronchodilator), birth control pills or hormone replacement, insulin or oral diabetes medicine, a steroid, or medicine to treat 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 in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with enzalutamide. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about enzalutamide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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