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Enzalutamide (By mouth)

Enzalutamide (en-za-LOO-ta-mide)

Treats metastatic prostate cancer. This medicine is an antiandrogen cancer medicine.

Brand Name(s):

Xtandi

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to enzalutamide. Women are not supposed to use this medicine, especially women who are pregnant or able to become pregnant.

How to Use This Medicine:

Liquid Filled Capsule

  • Take your medicine as directed.
  • You may take this medicine with or without food.
  • Swallow the capsule whole. Do not chew, dissolve, or open it.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you also use St John's wort, alfentanil (Alfenta®), bosentan (Tracleer®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), fentanyl (Actiq®, Duragesic®), gemfibrozil (Lopid®), midazolam (Versed®), modafinil (Provigil®), nafcillin (Nallpen®, Unipen®), omeprazole (Prilosec®), pimozide (Orap®), quinidine (Cardioquin®, Quinaglute®), sirolimus (Rapamycin®), or tacrolimus (Prograf®).
  • Tell your doctor if you also use medicine to treat HIV/AIDS (such as efavirenz, etravirine, Intelence®, Sustiva®), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, Rimactane®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®), a blood thinner (such as warfarin, Coumadin®, Jantoven®), or ergot medicine (such as dihydroergotamine, ergotamine, Cafergot®, Ergomar®, Wigraine®).

Warnings While Using This Medicine:

  • The medicine may cause birth defects if the father is using it when his sexual partner becomes pregnant. Tell your doctor right away if a pregnancy occurs. You must use a condom together with a second effective form of birth control during therapy and for 3 months after the last dose. This medicine can harm an unborn baby if a woman takes it while she is pregnant.
  • A small number of patients who have taken this medicine have had a seizure. Make sure your doctor knows if you have a history of brain injury, brain tumors, seizures, or stroke.
  • This medicine may cause dizziness, tiredness, muscle weakness, or seizures. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.
  • Continue to use the other medicines that your doctor has prescribed for cancer treatment. This includes a medicine called a gonadotropin-releasing hormone analog. Some examples of these are goserelin, leuprolide, Lupron®, or Zoladex®. Do not stop these medicines without checking with your doctor first.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Back pain, numbness or weakness in your leg
  • Change in how much or how often you urinate
  • Rapid weight gain, swelling in your hands, ankles, or feet
  • Seizure

If you notice these less serious side effects, talk with your doctor:

  • Bone, joint, or muscle pain
  • Cough, runny or stuffy nose, or sore throat
  • Diarrhea
  • Headache, dizziness
  • Tiredness or weakness
  • Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 11/4/2014
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