Prostate and other male cancers:

Indications for: ERLEADA

Metastatic castration-sensitive prostate cancer. Non-metastatic, castration-resistant prostate cancer.

Adult Dosage:

Swallow whole (alternatively, may be mixed in applesauce (4oz) if difficulty swallowing; 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 Dosage:

Not established.

ERLEADA 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 Classification:

Androgen receptor inhibitor.

ERLEADA Interactions:

Potentiated by strong CYP2C8 or CYP3A4 inhibitors; reduce dose based on tolerability. Antagonizes drugs metabolized by CYP3A4, CYP2C19, or CYP2C9; use alternatives when possible. Caution with concomitant P-gp, BCRP, OATP1B1, or UGT substrates.

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).

Metabolism:

CYP2C8, CYP3A4. 96% plasma protein bound.

Drug Elimination:

Renal (65%), fecal (24%). Half-life: ~3 days.

Generic Drug Availability:

NO

How Supplied:

Tabs—120