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 Patient Counseling Information 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 (4 tab) once daily.

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Overdosage

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Administration

May be taken with or without food: Swallow whole, do not crush. For patients w/ swallowing difficulties, mix whole tab in 120 mL applesauce & wait for 15 min then stir. Wait for another 15 mins then stir mixt until tab is dispersed & consume immediately.

Special Precautions

Monitor for signs & symptoms of ischemic heart disease & cerebrovascular disorders. Consider discontinuation for grade 3 & 4 cerebrovascular & ischemic CV events. Evaluate patients for fracture &/or fall risk. Permanently discontinue in patients who develop seizure during treatment. Monitor for development of severe cutaneous adverse reactions (SCARs) (including SJS/TEN & DRESS). Permanently discontinue if SCAR is confirmed, or other grade 4 skin reactions. Advise males w/ female partners of reproductive potential to use effective contraception during treatment & for 3 mth after the last dose. Can cause fetal harm & loss of pregnancy. Safety & effectiveness in ped patients have not been established. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Cerebrovascular & ischemic CV events, fractures, falls, seizure, SCARs, fatigue, arthralgia, rash, hypothyroidism, decreased appetite, decreased wt, HTN, hot flush, diarrhea; ILD; SJS/TEN, DRESS.

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Drug Interactions

Possible increase in steady-state exposure w/ strong CYP2C8 or CYP3A4 inhibitors. Lowered exposure of CYP3A4, CYP2C9, or CYP2C19 substrates; UGT 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

P₁S₁S₃

Patient Counseling Information

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Presentation/Packing

Form

Erleada FC tab 60 mg

Packing/Price

120's

Erleada

apalutamide

Manufacturer:

Johnson & Johnson

Distributor:

DCH Auriga - Healthcare

Four Star