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

Treats prostate cancer.

Brand Name(s):

Xtandi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Filled Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take it at the same time each day.
• Swallow the capsule whole. Do not chew, dissolve, or open it.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Your doctor may give you other medicines (including a gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how enzalutamide works. Tell your doctor if you are using gemfibrozil, itraconazole, midazolam, omeprazole, rifampin, or warfarin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Male patients with female partners should use an effective form of birth control during treatment with this medicine and for 3 months after the last dose. If you think your partner has become pregnant while using this medicine, tell your doctor right away.
• Tell your doctor if you have high blood pressure, diabetes, high cholesterol, or a history of a brain injury or tumor, seizures, or a stroke.
• This medicine may cause the following problems:
  • Seizures
  • Posterior reversible encephalopathy syndrome (PRES)
  • Heart problems
• This medicine may cause dizziness, tiredness, muscle weakness, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine, even for a short time, without first asking your doctor.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blistering, peeling, red skin rash
• Blurred vision, headache, fast, slow, pounding, or uneven heartbeat, lightheadedness, dizziness
• Chest pain or discomfort, pain in the shoulders, arms, jaw, or neck
• Headache, confusion, unusual drowsiness, tiredness, weakness, or feeling of sluggishness, blurred vision
• Seizures, loss of consciousness

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

• Back, joint, or muscle pain
• Constipation, diarrhea, nausea, vomiting, loss of appetite
• Warmth or redness in your face, neck, arms, or upper chest
• Weight loss

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