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

Erleada 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.

This medicine 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.

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

Although Erleada 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.

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

The usual dose of this medicine is 4 tablets taken at thesame 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 Erleada 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.

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.

Use: For the treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC)

Erleada is not for use by women or children.

This medicine 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 Erleada.

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.

To make sure Erleada 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 Erleada. 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.

Avoid driving or hazardous activity until you know how this medicine 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 Erleada: (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 this medicine. Use caution to avoid falling or accidental injury while you are being treated with this medicine.

Common Erleada 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.