Zytiga

Zytiga

abiraterone

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Abiraterone acetate
Indications/Uses
In combination w/ prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT); or have received prior chemotherapy containing taxane. In combination w/ ADT & prednisone or prednisolone for the treatment of adult men w/ newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).
Dosage/Direction for Use
Recommended dose: 1 g daily. Recommended dose (prednisone/prednisolone): For mHSPC: 5 mg daily. For mCRPC: 10 mg daily.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & women who are potentially pregnant.
Special Precautions
Patients whose underlying medical conditions might be compromised by increases in BP, hypokalemia or fluid retention eg, those w/ heart failure, recent MI or ventricular arrhythmia. History of CV disease. HTN & hypokalemia must be controlled prior to therapy. Monitor BP, serum K & fluid retention at least mthly. Monitor for adrenocortical insufficiency; symptoms of mineralocorticoid excess. Discontinue if patient develops severe hepatotoxicity. Hepatic impairment. Not for use in women.
Adverse Reactions
UTI; hypokalaemia; HTN; diarrhoea; peripheral oedema. Sepsis; hypertriglyceridaemia; cardiac failure, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; increased ALT & AST; rash; haematuria; fractures.
Drug Interactions
Decreased AUC w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb. Drugs activated or metabolized by CYP2D6 or w/ narrow therapeutic index. Drugs predominantly eliminated by CYP2C8. Decreased bone density in combination w/ a glucocorticoid.
ATC Classification
L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.
Presentation/Packing
Form
Zytiga tab 250 mg
Packing/Price
120's (Rp37,400,000/botol)
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