Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Erleada Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs 60mg—120; 240mg—30
Manufacturer
Generic Availability
Mechanism of Action
Erleada Indications
Indications
Erleada Dosage and Administration
Adult
Swallow whole (alternate methods of administration if difficulty swallowing tab; see full labeling). Take with or without food. 240mg once daily. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. Dose modifications: see full labeling.
Children
Erleada Contraindications
Not Applicable
Erleada Boxed Warnings
Not Applicable
Erleada Warnings/Precautions
Warnings/Precautions
Monitor for ischemic heart disease, cerebrovascular disorders; consider discontinuation for Grade 3/4 events. Manage CV risk factors (eg, hypertension, diabetes, dyslipidemia) optimally. Risk of seizures; permanently discontinue if occurs. Evaluate for fracture risk (monitor/manage based on guidelines; consider bone-targeted agents) and fall risk (esp. elderly). Monitor for severe cutaneous adverse reactions; interrupt therapy if suspected; permanently discontinue if confirmed. Embryo-fetal toxicity. Advise males (w. female partners of reproductive potential) to use effective contraception during and for 3 months after the last dose.
Erleada Pharmacokinetics
Absorption
Mean absolute oral bioavailability: ~100%. Median time to achieve peak plasma concentration (tmax): 2 hours (range: 1–5 hours).
Distribution
Plasma protein bound: 96% (apalutamide); 95% (N-desmethyl apalutamide).
Elimination
Erleada Interactions
Interactions
Erleada Adverse Reactions
Adverse Reactions
Fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, fracture; ischemic CV events, cerebrovascular disorders, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS).
Erleada Clinical Trials
See Literature
Erleada Note
Not Applicable
Erleada Patient Counseling
See Literature
