Apalutamide (a-pah-LOO-ta-mide)

Treats prostate cancer.

Brand Name(s):

Erleada

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not break, crush, or chew it.
• If you cannot swallow the tablet whole:
  • Place all the prescribed dose of tablets in a cup. Do not crush or split the tablet.
  • For one 240 milligram (mg) tablet: Add 2 teaspoons (10 mL) of non-carbonated water to make sure the tablet is completely covered in water.
  • For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Add 4 teaspoons (20 mL) of non-carbonated water to make sure the tablets are completely covered in water.
  • Wait for 2 minutes until the tablet has broken up, then stir the mixture well.
  • Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture.
  • Swallow the mixture right away.
  • Rinse the cup with enough non-carbonated water to make sure you that you take your full dose and drink it right away.
  • Do not store this mixture.
• You may also give the tablet through feeding tube:
  • For one 240 mg tablet: Place the tablet in the barrel of the syringe (at least a 20 mL syringe) and draw up 10 mL of non-carbonated water.
  • For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Place all the prescribed dose of tablets in the barrel of the syringe (at least a 50 mL syringe) and draw up 20 mL of non-carbonated water.
  • Wait for 10 minutes and shake the syringe well until the tablet is completely broken up.
  • Attach the syringe to the feeding tube and give the mixture right away.
  • Add non-carbonated water into the same syringe and flush through the feeding tube.
  • Repeat this step until no pieces of tablet are left in the syringe or feeding tube.
• 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. Keep this medicine in its original package.

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 apalutamide works. Tell your doctor if you are using fexofenadine, gemfibrozil, itraconazole, midazolam, omeprazole, rifampin, rosuvastatin, or warfarin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if a man is using it when his partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for 3 months after the last dose. Tell your doctor right away if a pregnancy occurs while you are using this medicine.
• Do not donate sperm during treatment with this medicine and for 3 months after your last dose.
• Tell your doctor if you have diabetes, high cholesterol, high blood pressure, a history of heart disease, seizures, brain injury, stroke, or brain tumor.
• This medicine may cause the following problems:
  • Increased risk of heart or blood vessel disease, including heart attack or stroke
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
• This medicine may cause seizures 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, or loosening of the skin
• Chest pain or discomfort, nausea or vomiting, pain in the shoulders, arms, jaw, or neck, sweating
• Joint or muscle pain
• Muscle weakness in the legs
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), problems with vision, speech, or walking
• Seizures, loss of consciousness
• Slow, fast, or uneven heartbeat, dizziness, headache
• Swelling, bruising, pain, or tenderness around the injured area
• Warmth or redness in your face, neck, arms, or upper chest

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

• Decreased appetite
• Diarrhea
• Tiredness
• Weight decreased

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