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ERLEADA
Prostate and other male cancers
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Drug Name:

ERLEADA Rx

Generic Name and Formulations:
Apalutamide 60mg; tabs.

Company:
Janssen Biotech, Inc.

Therapeutic Use:

Indications for ERLEADA:

Treatment of non-metastatic, castration-resistant prostate cancer.

Adult:

Swallow whole. Take with or without food. 240mg once daily. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. Dose modification: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

Warnings/Precautions:

Risk of seizures; permanently discontinue if occurs. Evaluate for fracture and fall risk. Males with female partners of reproductive potential: use effective contraception during and for 3 months after last dose.

Pharmacological Class:

Androgen receptor inhibitor.

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, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, fall, hot flush, decreased appetite, fracture, peripheral edema; possible male infertility.

Generic Availability:

NO

How Supplied:

Tabs—120

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