Generic name: apalutamide [ AP-a-LOOT-a-mide ]
Dosage form: oral tablet (240 mg; 60 mg)
Drug classes: Antiandrogens, Hormones / antineoplastics

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 29, 2023.

What is Erleada?

Erleada is to treat prostate cancer that has spread to other parts of the body (metastatic) and still responds to a medical or surgical treatment that lowers testosterone.

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

Erleada belongs to a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

This medicine is not approved for use in women or children.

Erleada side effects

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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Apalutamide may cause serious side effects. Call your doctor at once if you have:

• chest pain, feeling short of breath;

• a seizure;

• a fall; or

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Accidental falls may be more common in older adults who take Erleada. Use caution to avoid falling or accidental injury.

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.

Warnings

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 condition, allergies, and all medicines you use.

Before taking this medicine

To make sure Erleada is safe for you, 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

• high cholesterol or triglycerides.

Apalutamide can harm an unborn baby if the father is using Erleada.

• Use birth control if your sex partner is able to get pregnant. Men using Erleada should use condoms during treatment. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine. Do not donate sperm while you are taking Erleada, and during the 3 months after your last dose.

Apalutamide can weaken your bones. You may be more likely to have a broken bone while taking 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.

You may take Erleada with or without food but take it the same way each time.

Erleada is usually taken once per day. Follow your doctor's dosing instructions very carefully.

You may be given another medication while you are on Erleada, unless you have had surgery to remove your testicles. Keep using this medicine for as long as your doctor has prescribed.

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

Read and carefully follow the instructions provided with this medicine on how to prepare and take Erleada if you cannot swallow tablets whole. This medicine may also be given through a feeding tube. Ask your doctor or pharmacist if you don't understand these instructions.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Your condition may get worse if you stop using this medicine. Ask your doctor before stopping the medicine.

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

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.

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

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

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?

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

What other drugs will affect Erleada?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may interact with apalutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Ingredients

Active ingredient: apalutamide.
Inactive ingredients: 240mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer.
60mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufacturer

Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA.

Frequently asked questions

• Erleada vs. Xtandi: What's the difference?
• How long do you have to take Erleada (apalutamide) for?
• How effective is Erleada (apalutamide)?
• What type of prostate cancer is Erleada used to treat?

View more FAQ

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Erleada only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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