Apalutamide

ERLEADA

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Pronunciation: A-pa-loo-ta-mide (er-LEE-da)

Apalutamide ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Apalutamide ballicule

Apalutamide ERLEADA mascot mnemonic cartoon — Visual mnemonic: Apalutamide mascot
**“Ear leader, Air polluter”**
prostate cancer awareness ribbon

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.

Apalutamide molecular structure (skeletal formula) — Molecular structure: Apalutamide

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

Available strengths

tab 60, 240 mg

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.

Cost

Apalutamide (ERLEADA)

Strength		#/mo	generic $/mo	CostPlus
60 mg	tab	30 qd		not offered
240 mg	tab	30 qd		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Apalutamide is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2025

NO BOXED WARNINGS

Principal riskRash and falls; a strong CYP3A4 inducer

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades2 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityThrombotic, metabolic, hepatic, skeletal or reproductive toxicity varies by hormonal target.

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Memory aids: interaction avatars

CYP2C19 inducer (strong)

CYP3A4 inducer (strong)

Open Apalutamide in the interactive console ↗