Erleada

Erleada

apalutamide

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Apalutamide
Indications/Uses
Metastatic castration-sensitive prostate cancer. Non-metastatic, castration-resistant prostate cancer.
Dosage/Direction for Use
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. 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.
Adverse Reactions
Cerebrovascular & ischemic CV events, fractures, falls, seizure, fatigue, arthralgia, rash, hypothyroidism, decreased appetite, decreased wt, HTN, hot flush, diarrhea; ILD; SJS/TEN.
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.
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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