Generic Name and Formulations:
Apalutamide 60mg; tabs.
Janssen Biotech, Inc.
RECENT UPDATESMonograph added.
Indications for ERLEADA:
Treatment of non-metastatic, castration-resistant prostate cancer.
Swallow whole. 240mg once daily. Give concurrent gonadotropin-releasing hormone (GnRH) analog or patient should have had bilateral orchiectomy.
Permanently discontinue if seizure occurs. Evaluate for fracture and fall risk. Withhold dose if Grade ≥3 toxicity or intolerable side effect occurs; resume at same or reduced dose if improved to Grade ≤1 or original grade. Embryo-fetal toxicity. Female partners of reproductive potential: use effective contraception during and for 3 months after last dose.
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.
Androgen receptor inhibitor.
Fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, fall, hot flush, decreased appetite, fracture, peripheral edema; seizure, infertility.