Zuellig Pharma
Concise Prescribing Info
Abiraterone acetate
In combination w/ prednisone or prednisolone for metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after androgen deprivation therapy (ADT) failure in whom chemotherapy is not yet clinically indicated; mCRPC in adult men whose disease has progressed on or after docetaxel-based chemotherapy regimen; in combination w/ prednisone or prednisolone & ADT for patients w/ newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 mth prior to ADT.
Dosage/Direction for Use
1,000 mg as single daily dose w/ prednisone or prednisolone 10 mg daily for mCRPC & prednisone or prednisolone 5 mg daily for mHSPC.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Hypersensitivity. Severe hepatic impairment (Child-Pugh class C). Pregnancy.
Special Precautions
HTN, hypokalaemia or fluid retention; decreased bone density. History of CV disease. Patients using prednisone or prednisolone subjected to unusual stress & w/drawal. Patients previously treated w/ ketoconazole. Co-administration w/ radium 223 dichloride. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Moderate hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Peripheral oedema, hypokalaemia, HTN, UTI, hematuria, increased aspartate & alanine aminotransferase, dyspepsia, fractures.
Drug Interactions
Increased absorption w/ food, strong CYP3A inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb. Co-administration w/ CYP2D6-activated/metabolised drugs. CYP2C8 substrate w/ narrow therapeutic index.
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.
Zytiga tab 250 mg
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