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 (mCSPC) & non-metastatic castration-resistant prostate cancer (nmCRPC).

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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

Pregnancy.

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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.

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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

May increase steady-state C_max & AUC w/ gemfibrozil & ketoconazole. May decrease steady-state C_max & AUC w/ rifampin. Lowered exposure of CYP3A4, CYP2C19, or CYP2C9 substrates; UDP-glucuronosyl transferase substrates; P-gp, BCRP, or OATP1B1 substrates.

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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