What is ERLEADA used for?

ERLEADA is used to treat patients with metastatic castration-sensitive prostate cancer or non-metastatic castration-resistant prostate cancer.

How should I take apalutamide?

You should take 240 mg of apalutamide orally once daily by swallowing the tablets whole. Do not crush or split them.

Can I take apalutamide with food?

Yes, ERLEADA can be taken either with food or on an empty stomach.

Does apalutamide affect my heart?

Yes, there is a risk of heart-related issues like stroke or heart disease, so you should monitor for any signs of these conditions.

Can apalutamide cause skin problems?

Yes, severe skin reactions like Stevens-Johnson syndrome can occur, and you should stop the drug if these symptoms appear.

Is apalutamide safe for pregnant women?

No, ERLEADA can cause fetal harm and loss of pregnancy; men should use effective contraception.

What should I do if I have a seizure while taking apalutamide?

If you experience a seizure while taking apalutamide, you must stop taking the medication permanently.

What happens if I miss a dose or take too much apalutamide?

There is no specific antidote for an overdose; you should stop the medication and seek medical help to manage symptoms.

Does apalutamide interact with other medications?

Yes, it can lower the effectiveness of many other drugs metabolized by certain liver enzymes.

apalutamide | CAS 956104-40-8 | HJBWBFZLDZWPHF

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Androgen receptor antagonist

Apalutamide (brand name ERLEADA) is an oral medication used to treat certain types of prostate cancer, specifically metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer. It works by blocking androgen receptors in the body to help stop cancer cells from growing.

How it worksApalutamide is an androgen receptor inhibitor. It binds to the androgen receptor to prevent it from moving into the cell nucleus, which stops the receptor from helping the cancer grow.

Brand names:ERLEADA

Used for

Metastatic castration-sensitive prostate cancer (mCSPC)Non-metastatic castration-resistant prostate cancer (nmCRPC)

Conditions

Metastatic castration-sensitive prostate cancerNon-metastatic castration-resistant prostate cancer

Class

Androgen Receptor InhibitorAntineoplasticAndrogen receptor antagonistEndocrine SystemGenitourinary System

How to take

Forms240 mg tablet, 60 mg tablet

Routesoral

The recommended dose is 240 mg taken by mouth once daily. This can be taken as one 240 mg tablet or four 60 mg tablets. You can take it with or without food, but you must swallow the tablets whole without crushing or splitting them.

Patients must also take a GnRH analog or have had a bilateral orchiectomy at the same time.

Key warnings

·Monitor for signs of heart disease or stroke.
·There is a risk of bone fractures; discuss bone-health management with your doctor.
·Elderly patients may be at a higher risk of falls.
·If a seizure occurs, the medication must be stopped permanently.
·Severe skin reactions require stopping the medication immediately.
·Lung inflammation (ILD) requires withholding the drug and may require permanent discontinuation.
·Apalutamide can cause harm to an unborn baby. Men should use effective contraception if they have female partners who could become pregnant.

Do not use if

·None listed

Side effects

Common

FatigueJoint pain (arthralgia)RashDecreased appetiteFallsWeight lossHigh blood pressure (hypertension)Hot flashesDiarrheaBone fractures

Serious

·Heart-related issues (cerebrovascular or ischemic cardiovascular events)
·Seizures
·Severe skin reactions (such as Stevens-Johnson syndrome or DRESS)
·Lung problems (Interstitial Lung Disease or pneumonitis)
·Bone fractures

Seek help if

·Seizures
·Severe skin rashes
·Difficulty breathing (lung issues)
·Signs of stroke or heart attack

Interactions

·Apalutamide can make other drugs less effective if they are processed by certain liver enzymes (CYP3A4, CYP2C19, CYP2C9, etc.).
·Strong inhibitors of CYP2C8 or CYP3A4 may increase the levels of apalutamide in your body.
·Known interacting drugs include Casodex, Nuveqa, and Winlevi.

FoodERLEADA can be taken with or without food.

Special populations

PregnancyApalutamide can cause fetal harm and loss of pregnancy. It is not recommended for use in pregnant women, and men should use protection to prevent pregnancy.

PediatricThe safety and effectiveness of ERLEADA in children have not been established.

GeriatricWhile effectiveness is similar in older patients, the risk of severe side effects and falls is higher in those aged 75 and older.

Talk to your doctor

Monitor

·Signs of cerebrovascular or cardiovascular issues
·Signs of skin reactions
·Signs of lung disease (shortness of breath, cough)
·Blood pressure
·PSA levels

Questions to ask

·What are my risks for heart-related events while on ERLEADA?
·How can I manage the risk of bone fractures?
·Should I be screened for lung disease?
·What other medications might interact with ERLEADA?

Pharmacokinetics

MetabolismApalutamide is metabolized, with N-desmethyl apaulutamide as a major metabolite. It is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9.

Practical

OverdoseThere is no specific antidote for an overdose. If an overdose occurs, stop taking the medicine and seek medical support to manage symptoms.

StorageStore at room temperature between 68°F to 77°F. Keep in the original package to protect from light and moisture. Do not throw away the desiccant.

Ingredients

Inactive

colloidal anhydrous silicacroscarmellose sodiumhydroxypropyl methylcellulose-acetate succinatesilicified microcrystalline cellulosemagnesium stearateglyceryl monocaprylocaprateiron oxide blackpolyvinyl alcoholtalctitanium dioxidevinyl alcohol grafted copolymermicrocrystalline celluloseferrosoferric oxideferric oxide yellowpolyethylene glycol

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.