Apalutamide
ERLEADA
What it isAndrogen receptor antagonist; non-metastatic castration-resistant and metastatic prostate cancer.
Why this oneRash is more characteristic than with enzalutamide, while CNS and interaction burdens are heavier than with darolutamide.
What limits itFalls, fractures, hypothyroidism, and seizure risk can end treatment. Strong enzyme induction disrupts many co-medications.
FDA-approved for
- prostate cancer (2018)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Prostate cancer (non-metastatic castration-resistant or metastatic castration-sensitive) | Adult male | 240 mg QD | 240 mg QD | 240 mg QD |
Renal Undefined
Hepatic Severe impairment (Child-Pugh C): 120 mg QD; mild-to-moderate: no adjustment.
Instructions
- Swallow tablets whole; do not crush or split
- Take with or without food
- Give a GnRH analog concurrently or have had bilateral orchiectomy
Cautions
- Cerebrovascular and ischemic cardiovascular events
- Fractures
- Falls (increased in elderly)
- Seizure (0.4%)
- Severe cutaneous adverse reactions (SCARs)
- Interstitial lung disease
Adverse reactions
- Fatigue
- Arthralgia
- Rash
- Decreased appetite
- Fall
- Weight loss
- Hypertension
- Hot flush
- Diarrhea
- Fracture
Pregnancy Can cause fetal harm and loss of pregnancy based on animal findings and mechanism; not indicated in females.
Lactation Not indicated in females; no data on presence in human milk.
NO BOXED WARNINGS
Principal riskRash and falls; a strong CYP3A4 inducer
Cost, est. cash$500–$15,000/month
Generic entry2025
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityThrombotic, metabolic, hepatic, skeletal or reproductive toxicity varies by hormonal target.
Mechanism of action: Apalutamide ballicule
Open Apalutamide in the interactive console ↗
Memory aids: mascots and interaction avatars
prostate cancer awareness ribbon
