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Generic Name: enzalutamide (ENZ a LOOT a mide)
Brand Names: Xtandi

What is Xtandi?

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

Xtandi is used to treat prostate cancer.

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

Important information

Although not for use by women, Xtandi 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.

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

Before taking this medicine

Xtandi 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, Xtandi can cause birth defects if the mother or the father is taking this medicine. Do not use Xtandi if you are pregnant.

If you are taking Xtandi 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 Xtandi?

Take Xtandi exactly as prescribed by your doctor. 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 Xtandi with or without food. Take the medicine at the same time each day.

Do not crush, break, or dissolve a capsule. Swallow the capsule 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.

Xtandi dosing information

Usual Adult Dose for Prostate Cancer:

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

Use: Metastatic castration-resistant prostate cancer

See also: Dosage Information (in more detail)

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 Xtandi?

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. Severe dizziness can cause falls or other accidents.

Enzalutamide 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.

Xtandi side effects

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

Xtandi 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 Xtandi 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 Xtandi 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.

See also: Side effects (in more detail)

What other drugs will affect Xtandi?

Xtandi 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 Xtandi. 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 Xtandi.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xtandi only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 2.03. Revision Date: 2016-10-31, 4:22:10 PM.

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