Erleada Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Apalutamide

Indications/Uses

Metastatic castration-sensitive prostate cancer. Non-metastatic, castration-resistant prostate cancer.

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Dosage/Direction for Use

240 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Women who are or may become pregnant.

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Special Precautions

Discontinue use if seizure or signs or symptoms of severe cutaneous adverse reactions (including DRESS & SJS/TEN) develop. Evaluate patients for fracture & fall risk. Monitor for signs & symptoms of ischemic heart disease & cerebrovascular disorders. Patients w/ severe renal impairment or ESRD (eGFR ≤29 mL/min/1.73 m²) or severe hepatic impairment (Child-Pugh class C). Patients w/ female partners of reproductive potential should use a condom along w/ another highly effective contraception during treatment & for 3 mth after last dose. May impair fertility in males of reproductive potential.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Steady-state C_max & AUC may be increased w/ gemfibrozil (strong CYP2C8 inhibitor) & ketoconazole (strong CYP3A4 inhibitor). Steady-state C_max & AUC may be decreased w/ rifampin (strong CYP3A4 & moderate CYP2C8 inducer). Lowered exposure of CYP3A4, CYP2C19, or CYP2C9 substrates; UDP-glucuronosyl transferase substrates; P-gp, BCRP, or OATP1B1 substrates. Monitor INR in concomitant use w/ warfarin.

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Storage

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Description

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Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BB05 - apalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Erleada FC tab 60 mg

Packing/Price

120's

Erleada

apalutamide

Manufacturer:

Janssen Ortho

Distributor:

Johnson & Johnson