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.

Slideshow: Flashback: FDA Drug Approvals 2013

Xtandi can increase your risk of having a seizure. Tell your doctor if you have a history of seizures, or if you have recently had a head injury, stroke, or brain tumor. Also tell your doctor about all medicines you use.

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:

  • a history of seizures or epilepsy; or

  • a recent head injury, stroke, or brain tumor (in the past 12 months).

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

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Xtandi.

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 Xtandi 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.

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.

What should I avoid?

Xtandi 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.

Xtandi side effects

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

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

  • seizure (black-out or convulsions);

  • severe low back pain, trouble walking or standing up;

  • pain or weakness in your lower body, severe and worsening numbness or tingly feeling;

  • sudden loss of bladder or bowel control;

  • fever, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

  • red or pink urine; or

  • increased blood pressure (severe headache, blurred vision, buzzing in your ears, confusion, chest pain, uneven heartbeats).

Common Xtandi side effects may include:

  • anxiety, dizziness, headache, sleep problems (insomnia);

  • feeling weak or tired;

  • back pain, joint or muscle pain, muscle weakness;

  • flushing (warmth, redness, hot feeling);

  • numbness, burning pain, or prickly feeling under your skin;

  • swelling in your hands or feet;

  • diarrhea; 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 (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 Xtandi. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with this medicine, especially:

  • gemfibrozil;

  • quinidine;

  • alfentanil, fentanyl;

  • dihydroergotamine, ergotamine;

  • a blood thinner such as warfarin, Coumadin;

  • herbal products--echinacea, St. John's wort;

  • HIV/AIDS medication--efavirenz, etravirine, nevirapine, ritonavir;

  • medicine for narcolepsy--armodafinil, modafinil;

  • medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone, rufinamide; or

  • tuberculosis medication--rifampin.

This list is not complete and many other drugs can interact with Xtandi. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 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 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-03-12, 11:30:36 PM.

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