Generic Name and Formulations:
Apalutamide 60mg; tabs.
Janssen Biotech, Inc.
Indications for ERLEADA:
Treatment of non-metastatic, castration-resistant prostate cancer.
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.
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.
Androgen receptor inhibitor.
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.
Fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, fall, hot flush, decreased appetite, fracture, peripheral edema; possible male infertility.