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Erleada

Erleada

apalutamide

Manufacturer:

Janssen Ortho

Distributor:

Johnson & Johnson
Concise Prescribing Info
Contents
Apalutamide
Indications/Uses
Metastatic castration-sensitive prostate cancer (mCSPC) & non-metastatic castration-resistant prostate cancer (nmCRPC).
Dosage/Direction for Use
Administration
May be taken with or without food.
Special Precautions
Permanently discontinue if seizure develops during treatment. Evaluates patients for fractures and fall risk. Monitor for signs & symptoms of ischemic heart disease & ischemic cerebrovascular disorder. Patients w/ female partners of reproductive potential should use highly effective contraceptive method during treatment & for 3 mth after last dose. May impair fertility in males of reproductive potential. Childn ≤17 yr.
Adverse Reactions
Fatigue; arthralgia; skin rash; HTN, hot flush; diarrhea; fall, fracture; decreased wt. Muscle spasm; pruritus; dysgeusia, ischemic cerebrovascular disorders; hypercholesterolemia, hypertriglyceridemia; ischemic heart disease; hypothyroidism.
Drug Interactions
May increase steady-state Cmax & AUC w/ gemfibrozil & ketoconazole. May decrease steady-state Cmax & AUC w/ rifampin. Lowered exposure of CYP3A4, CYP2C19, or CYP2C9 substrates; UDP-glucuronosyl transferase substrates; P-gp, BCRP, or OATP1B1 substrates.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB05 - apalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Erleada FC tab 60 mg
Packing/Price
120's
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