Generic Name: enzalutamide (EN-za-LOO-ta-mide)
Brand Name: Xtandi

Xtandi is used for:

Treating certain types of prostate cancer that have spread to other parts of the body. It may also be used for other conditions as determined by your doctor.

Xtandi is an androgen receptor inhibitor. It works by blocking the action of testosterone.

Do NOT use Xtandi if:

  • you are allergic to any ingredient in Xtandi
  • you are pregnant or are planning to or may become pregnant
  • you are taking alfentanil, apixaban, artemether-lumefantrine, avanafil, axitinib, bortezomib, bosutinib, cabazitaxel, crizotinib, cyclosporine, dabigatran, dihydroergotamine, ergotamine, fentanyl, ivacaftor, lurasidone, mifepristone, phenytoin, pimozide, certain protease inhibitors (eg, boceprevir, indinavir, ritonavir), quinidine, rilpivirine, rivaroxaban, roflumilast, sirolimus, tacrolimus, ticagrelor, vandetanib, or vincristine liposome

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Xtandi:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if your sexual partner is pregnant, may become pregnant, or is planning to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems, or certain brain blood vessel problems
  • if you have a history of seizures, brain injury, cancer in the brain, stroke, or transient ischemic attack (TIA) or "mini-stroke"

Some MEDICINES MAY INTERACT with Xtandi. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Gemfibrozil or itraconazole because they may increase the risk of Xtandi's side effects
  • Bosentan, carbamazepine, efavirenz, etravirine, modafinil, nafcillin, phenobarbital, rifamycins (eg, rifampin), or St. John's wort because they may decrease Xtandi's effectiveness
  • Alfentanil, apixaban, artemether-lumefantrine, avanafil, axitinib, bortezomib, bosutinib, brentuximab, cabazitaxel, crizotinib, cyclosporine, dabigatran, dihydroergotamine, elvitegravir, ergotamine, estradiol valerate, fentanyl, ivacaftor, lurasidone, midazolam, mifepristone, omeprazole, phenytoin, pimozide, protease inhibitors (eg, boceprevir, indinavir, ritonavir), quinidine, rilpivirine, rivaroxaban, roflumilast, sirolimus, tacrolimus, ticagrelor, ulipristal, vandetanib, vincristine liposome, or warfarin because their effectiveness may be decreased by Xtandi

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xtandi may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xtandi:

Use Xtandi as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Xtandi. Talk to your pharmacist if you have questions about this information.
  • Take Xtandi by mouth with or without food at the same time each day.
  • Swallow Xtandi whole. Do not dissolve, chew, or open the capsules before swallowing.
  • If you are taking another prostate cancer medicine along with Xtandi, continue taking it, unless your doctor tells you otherwise.
  • If you miss a dose of Xtandi, take it as soon as possible that same day. If you do not remember to take your dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xtandi.

Important safety information:

  • Xtandi may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Xtandi with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose of Xtandi or stop taking it without checking with your doctor.
  • Seizures have occurred in patients taking Xtandi. The risk of seizures may be increased if you have certain brain blood vessel problems; if you have a history of seizures, brain injury, cancer in the brain, stroke, or transient ischemic attack (TIA) or "mini-stroke;" or if you are taking certain other medicines. Ask your doctor or pharmacist if you are unsure if any of your medicines may increase this risk.
  • Because of the risk of seizures with Xtandi, avoid any activity in which sudden loss of consciousness may cause harm to yourself or others. Discuss any questions or concerns with your doctor.
  • You must always use a condom when having sex with a pregnant woman. Do this for as long as you take Xtandi and for 3 months after you stop taking it. If your sexual partner may become pregnant, you must always use a condom and another form of effective birth control while taking Xtandi and for 3 months after you stop taking it. Talk with your health care provider if you have questions about birth control.
  • Xtandi should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Xtandi is not approved for use in women. Do not use Xtandi if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Xtandi is found in breast milk. Do not breast-feed while taking Xtandi.

Possible side effects of Xtandi:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cold-like symptoms (eg, cough, runny or stuffy nose, sneezing, sore throat); diarrhea; dizziness; headache; hot flashes; mild back, bone, joint, or muscle pain; tiredness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; back pain with leg numbness or weakness; changes in the amount of urine produced; confusion or problems thinking clearly; decreased sense of touch; feeling of tingling, burning, pricking, or numbness of the skin; fever, chills, or persistent sore throat; hallucinations; memory problems; muscle aches or weakness; pink or red urine; seizures; severe or persistent headache; shortness of breath; swelling of the hands, arms, legs, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures.

Proper storage of Xtandi:

Store Xtandi at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xtandi out of the reach of children and away from pets.

General information:

  • If you have any questions about Xtandi, please talk with your doctor, pharmacist, or other health care provider.
  • Xtandi is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xtandi or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xtandi. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xtandi. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Xtandi.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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