Erleada (apalutamide)
Janssen Oncology (Johnson & Johnson) · Androgen Receptor Inhibitor
What is Erleada? Erleada (apalutamide) is an androgen receptor inhibitor by Janssen approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), used in combination with androgen deprivation therapy (ADT).
About Erleada
| Brand Name | Erleada |
| Generic / INN | apalutamide |
| Drug Class | Androgen Receptor Inhibitor |
| Manufacturer | Janssen Oncology (Johnson & Johnson) |
| Administration | Oral tablet |
| FDA Approval | 2018 |
FDA-Approved Uses for Erleada
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC) — in combination with androgen deprivation therapy
How Does Erleada Work?
Apalutamide binds directly to the ligand-binding domain of the androgen receptor (AR), blocking AR nuclear translocation, DNA binding, and AR-mediated transcription. It inhibits multiple steps in the AR signaling pathway more completely than first-generation antiandrogens (e.g., bicalutamide). Used with ADT (GnRH agonist/antagonist or surgical castration).
Dosage & Administration
240 mg (four 60 mg tablets) orally once daily, with or without food. Swallow whole. Dose reductions to 180 mg or 120 mg for toxicity (seizures, ischemia, fractures, grade 3+ adverse reactions).
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
Seizures — use with caution in patients with seizure history or risk factors. Ischemic cardiovascular events. Falls and fractures (bone-protective agents recommended). Hypothyroidism — monitor thyroid function. Embryo-fetal toxicity. Strong CYP3A4/2C8 drug interactions.
- Seizures
- Ischemic cardiovascular events
- Falls and fractures
- Hypothyroidism
- Embryo-fetal toxicity
Common Side Effects
- Fatigue
- Arthralgia
- Rash
- Decreased appetite
- Falls
- Weight loss
- Hypertension
- Hot flush
- Diarrhea
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Store at room temperature 20°C to 25°C (68°F to 77°F). Store below 30°C.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Erleada is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Erleada. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Erleada
Erleada (apalutamide) is an androgen receptor inhibitor by Janssen approved for nmCRPC and mCSPC. It blocks testosterone from stimulating prostate cancer cell growth and is used with androgen deprivation therapy.
Non-metastatic castration-resistant prostate cancer (nmCRPC) is prostate cancer that continues to progress (rising PSA) despite castrate levels of testosterone, but has not yet spread to other organs detectable by imaging.
Seizures have been reported with apalutamide. Patients with a history of seizures or risk factors should use Erleada with caution. Avoid driving or other hazardous activities if you experience a seizure.
240 mg once daily (four 60 mg tablets), with or without food.
Erleada is covered by most commercial insurance plans and Medicare Part D with prior authorization. BiologicHealthPlus handles the full PA process.
Related Medications & Conditions
Related Medications
Xtandi (enzalutamide) · Nubeqa (darolutamide) · Abiraterone Acetate · Orgovyx (relugolix — ADT)
Related Conditions
Non-metastatic castration-resistant prostate cancer (nmCRPC) · Metastatic castration-sensitive prostate cancer (mCSPC) · Prostate cancer