Erleada

Erleada

apalutamide

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Apalutamide
Indications/Uses
Metastatic castration-sensitive prostate cancer & non-metastatic castration-resistant prostate cancer.
Dosage/Direction for Use
240 mg (equiv to 4 tab) once daily.
Administration
May be taken with or without food.
Special Precautions
Permanently discontinue in patients who develop seizure during treatment. Consider discontinuation for Grade 3 & 4 cerebrovascular & ischemic CV events. Monitor for signs & symptoms of ischemic heart disease & cerebrovascular disorders. Optimize management of CV risk factors eg, HTN, diabetes or dyslipidemia. Monitor & manage patients at risk for fractures. Evaluate patients for risk of fracture; fall. May impair fertility in males of reproductive potential. Male patients w/ female partners of reproductive potential should use effective contraception during treatment & for 3 mth after last dose. Pregnancy & lactation. Ped patients. Increased frequency of falls in elderly.
Adverse Reactions
Arthralgia; rash, pruritus; hot flush, HTN; fatigue; decreased appetite, peripheral edema; fall, fracture; decreased wt; diarrhea, nausea; decreased WBC, anemia, leukopenia, lymphopenia; hypertriglyceridemia, hypercholestrolemia, hyperglycemia, hyperkalemia. Muscle spasm; dysgeusia; hypothyroidism; heart failure.
Drug Interactions
Increased steady-state exposure of active moieties w/ strong CYP2C8 or CYP3A4 inhibitors. Decreased exposure of CYP3A4, CYP2C9, CYP2C19 & UDP-glucuronosyl transferase substrates; fexofenadine (P-gp substrate) & rosuvastatin (BCRP/OATP1B1 substrate).
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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