Apalutamide is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

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).

Although apalutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

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.

Before taking this medicine

Apalutamide is not for use by women or children.

Apalutamide can harm an unborn baby or cause miscarriage. Apalutamide can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.

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 this medicine.

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 this medicine, and during the 3 months after your last dose.

To make sure this medicine is safe for you, tell your doctor if you have:

• 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.

Take apalutamide exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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.

Swallow the tablets whole and do not crush, chew, or break them.

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.

Store at room temperature away from moisture, heat, and light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Prostate Cancer:

240 mg orally once a day

Comments:
-Patients should receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy.

Uses:
-For the treatment of metastatic castration-sensitive prostate cancer (mCSPC)
-For the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC)

Apalutamide is not for use by women or children.

Apalutamide can harm an unborn baby or cause miscarriage. Apalutamide can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.

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 this medicine.

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 this medicine, and during the 3 months after your last dose.

To make sure this medicine is safe for you, tell your doctor if you have:

• 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.

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.

Call your doctor for instructions if you miss an appointment for your GnRH injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how apalutamide will affect you. Your reactions could be impaired.

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

Get emergency medical help if you have signs of an allergic reaction to apalutamide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• 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 apalutamide 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.

Other drugs may interact with 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to apalutamide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.