Apalutamide is a prescription medicine. It is available as tablets for oral use. MedsAcross supplies Apalutamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. non-metastatic castration-resistant prostate cancer.
Source: US FDA prescribing information
Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.
Source: US FDA prescribing information
ERLEADA 240 mg orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. The recommended ERLEADA dosage in patients with severe hepatic impairment is 120 mg orally once daily. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Cerebrovascular and ischemic cardiovascular events occurred in patients receiving ERLEADA. Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease. Optimize management of cardiovascular risk factors. Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines. Falls occurred in patients receiving ERLEADA with increased incidence in the elderly. Evaluate patients for fall risk. Seizure occurred in 0.4% of patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients treated with ERLEADA.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events. Fractures. Falls. Seizure. Severe Cutaneous Adverse Reactions (SCARs). Interstitial Lung Disease (ILD). The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
Source: US FDA prescribing information
Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications.
Source: US FDA prescribing information
Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). Store in original package to protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Apalutamide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Erleada 240 mg tabletOral | Janssen Products | US FDA | Available on request |
| Erleada 60 mg tabletOral | Janssen Products | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Apalutamide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Apalutamide, including Erleada.
Yes. The US FDA first approved Apalutamide on 14 February 2018, according to Drugs@FDA.
Yes. Apalutamide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Apalutamide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Apalutamide is classified under ATC code L02BB05 (Apalutamide).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.