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Apalutamide

Generic name: apalutamide [ AP-a-LOOT-a-mide ]
Brand name: Erleada
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 apalutamide?

Apalutamide 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.

Apalutamide 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.

Apalutamide 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.

Apalutamide side effects

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).

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:

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 this medicine. Use caution to avoid falling or accidental injury.

Common apalutamide side effects may include:

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 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 condition, allergies, and all medicines you use.

Before taking this medicine

To make sure apalutamide is safe for you, tell your doctor if you have ever had:

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

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 apalutamide, 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 this medicine. Talk with your doctor about ways to keep your bones healthy.

How should I take apalutamide?

Take apalutamide 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 apalutamide with or without food but take it the same way each time.

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

You may be given another medication while you are on apalutamide, 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 apalutamide 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 apalutamide?

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

What other drugs will affect apalutamide?

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.

Frequently asked questions

More about apalutamide

Patient resources

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Professional resources

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Further information

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

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