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Erleada

Erleada

apalutamide

Manufacturer:

Janssen Ortho

Distributor:

Johnson & Johnson
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: Swallow tab whole.
Contraindications
Women who are or may become pregnant.
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Special Precautions
Discontinue use if signs or symptoms of severe cutaneous adverse reactions (including DRESS & SJS/TEN) develop. Permanently discontinue in patients who develop seizure during treatment. Evaluate patients for fracture & fall risk. Monitor for signs & symptoms of ischemic heart disease & cerebrovascular disorders. No data available in 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 Cmax & AUC may be increased w/ gemfibrozil (strong CYP2C8 inhibitor) & ketoconazole (strong CYP3A4 inhibitor). Steady-state Cmax & 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
Rx
Presentation/Packing
Form
Erleada FC tab 60 mg
Packing/Price
120's