Clinical Information
Gen. Code and Des.
78163 apalutamide ORAL TABLET 60 MG
GCN and Des.
44446 apalutamide ORAL TABLET 60 MG
Strength
60MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
17466 apalutamide
INDICATIONS AND USAGE
ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer. (1)
DOSAGE AND ADMINISTRATION
ERLEADA 240 mg (four 60 mg tablets) administered orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. (2.1)
Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 60 mg (3)
CONTRAINDICATIONS
Pregnancy (4, 8.1)
WARNINGS AND PRECAUTIONS
Falls and Fractures occurred in 16% and 12% of patients receiving ERLEADA, respectively. Evaluate patients for fracture and fall risk, and treat patients with bone targeted agents according to established guidelines. (5.1)
Seizure occurred in 0.2% of patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (≥10%) are fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications. (7.2)
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2018