Apalutamide (Erleada) is an androgen receptor inhibitor widely used in the treatment of metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.

How to Use Apalutamide (Erleada)

Recommended Dosage Regimen

The standard dose is 240 mg, taken orally once daily.

It can be administered as one whole 240 mg tablet or four 60 mg tablets swallowed entirely.

There is no need to crush or split the tablets during administration.

It can be taken with or without food, as food does not affect the absorption of the drug.

Concomitant Treatment Requirements

Patients must receive concurrent treatment with gonadotropin-releasing hormone (GnRH) analogs.

Or have undergone bilateral orchiectomy.

Administration Precautions

If a dose is missed, it should be taken as soon as possible within the same day, and the regular dosing schedule should be resumed the next day.

Do not take an extra dose to make up for the missed one.

Dosage Adjustment of Apalutamide (Erleada)

Indications for Permanent Discontinuation

Grade 3 or Grade 4 cerebrovascular and ischemic cardiovascular events.

Severe interstitial lung disease/pneumonia.

Confirmed severe cutaneous adverse reactions or other Grade 4 cutaneous reactions.

Dosage Resumption and Adjustment

When symptoms improve to Grade 1 or below.

Apalutamide treatment may be resumed, and the dosage can be maintained at the original dose or reduced to 180 mg or 120 mg.

Medication for Special Populations of Apalutamide (Erleada)

For Patients Unable to Swallow Whole Tablets

Tablets can be dispersed in non-carbonated water and then mixed with orange juice, applesauce, or additional water for administration.

Place the prescribed dose of tablets into a cup.

Add approximately 10 mL of water for a 240 mg tablet; add approximately 20 mL of water for 60 mg tablets (for doses of 240 mg, 180 mg, or 120 mg).

Wait for 2 minutes until the tablets break apart and disperse.

Add 30 mL of orange juice, applesauce, or additional water and stir the mixture.

Swallow the mixture immediately.

Rinse the cup wall with sufficient water to ensure the entire dose is consumed.

Patients with Hepatic Impairment

No dosage adjustment is required for patients with mild to moderate hepatic impairment.

There is insufficient data on the use of this drug in patients with severe hepatic impairment.

Patients with Renal Impairment

No dosage adjustment is needed for patients with mild to moderate renal impairment (eGFR 30-89 mL/min/1.73m²).

There is insufficient data on the use of this drug in patients with severe renal impairment or end-stage renal disease.

Male Patients with Reproductive Potential

Effective contraceptive measures should be taken during treatment and for 3 months after the last dose.

Condoms should be used during sexual intercourse with pregnant women.