Apalutamide (By mouth)

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Introduction

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

Treats prostate cancer.

Brand Name(s)

Erleada

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

This medicine is not right for everyone. Do not use it if you had an allergic reaction to apalutamide.

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.
  • 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 or rosuvastatin.

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 a history of seizures, brain injury, stroke, or brain tumor.
  • 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
  • Muscle weakness in the legs
  • Seizures, loss of consciousness
  • Swelling, bruising, pain, or tenderness around the injured area

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

  • Decreased appetite
  • Diarrhea, nausea
  • 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

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