apalutamide

What is the most important information I should know about apalutamide?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is apalutamide?

Apalutamide is used to treat prostate cancer that has spread to other parts of the body (metastatic) and is also being treated with another medicine or with surgery.

Apalutamide is also used to treat prostate cancer that has not spread to other parts of the body, after surgery or other cancer treatments did not work or have stopped working.

Apalutamide is used together with a gonadotropin-releasing hormone (GnRH) or with surgical castration (removal of the testicles).

Apalutamide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking apalutamide?

Apalutamide is not for use by women or children.

Use effective birth control if your sex partner is able to become pregnant. Use condoms if your sex partner is pregnant. Keep using effective birth control and condoms for at least 3 months after your last dose of apalutamide.

Apalutamide may affect fertility (your ability to have children). However, it is important to use birth control to prevent pregnancy because apalutamide may harm the baby if a pregnancy does occur.

Also do not donate sperm while you are taking apalutamide, and during the 3 months after your last dose.

Tell your doctor if you have ever had:

• a head injury or brain tumor;
• a seizure;
• a stroke;
• heart disease, high blood pressure;
• diabetes; or
• abnormal levels of cholesterol or fats in your blood.

Hormonal cancer treatment can weaken your muscles and bones. You may be more likely to have a broken bone while using apalutamide. Talk with your doctor about ways to keep your bones healthy.

How should I take apalutamide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take apalutamide with or without food, at the same time each day.

The usual dose of this medicine is 4 tablets taken at the same time once daily. Follow your doctor's dosing instructions very carefully.

If you cannot swallow the tablets whole, mix the tablets in a cup with 4 ounces of applesauce. After 15 minutes, stir the mixture and wait another 15 minutes. Stir again until the tablets are completely dispersed in the applesauce. Swallow the mixture right away. Do not save it for later use.

Add 2 ounces of water to the same cup and drink the entire contents. Add 2 more ounces of water to the cup, swirl gently and drink right away.

You will need frequent medical tests.

You should not stop using apalutamide unless your doctor tells you to.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking apalutamide?

Apalutamide can cause seizures. Avoid activities that could be dangerous if you have an unexpected seizure.

What are the possible side effects of apalutamide?

• chest pain or discomfort (even while at rest), shortness of breath;
• a seizure;
• a fall; or
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems.

Accidental falls may be more common in elderly patients who use apalutamide. Use caution to avoid falling or accidental injury while you are being treated with this medicine.

Common side effects may include:

• hot flashes;
• diarrhea, loss of appetite;
• weight loss;
• tiredness;
• falls;
• rash;
• joint pain;
• increased blood pressure; or
• bone fractures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect apalutamide?

Other drugs may affect apalutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about apalutamide.