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

Erleada is used to treat prostate cancer.

Erleada is used together with another hormone or with surgical castration (removal of the testicles).

Important Information

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

Before taking this medicine

You should not use Erleada if you are allergic to apalutamide.

Erleada should never be taken by a woman or a child.

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

Use effective birth control if your sex partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is using Erleada. Keep using birth control for at least 3 months after your last dose.

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

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.

Tell your doctor if you have ever had:

• a head injury or brain tumor;
• a seizure; or
• a stroke.

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.

How should I take Erleada?

Take Erleada exactly as prescribed by your doctor. 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 Erleada with or without food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

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

Store at room temperature away from moisture and heat.

Erleada dosing information

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)

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.

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

What happens if I overdose?

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

What should I avoid while taking Erleada?

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.

Erleada side effects

Get emergency medical help if you have signs of an allergic reaction to Erleada: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a seizure.

Common Erleada side effects may include:

• hot flashes;
• swelling in your hands, ankles, or feet;
• nausea, diarrhea, loss of appetite;
• increased blood pressure;
• feeling tired;
• joint pain;
• 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 Erleada?

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.