Glenmark Pharma


Uni Drug House
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 ADT.
Dosage/Direction for Use
1,000 mg as single daily dose w/ prednisone or prednisolone 10 mg daily for mCRPC & 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. Combination w/ Ra-223. Severe hepatic impairment (Child-Pugh class C). Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue use if severe hepatotoxicity develops. HTN, hypokalaemia or fluid retention; heart failure, recent MI or ventricular arrhythmia, QT prolongation, Torsade de pointes; decreased bone density. History of CV disease. Patients subjected to unusual stress & corticosteroid w/drawal. Monitor serum transaminases & bilirubin levels every 2 wk for 1st 3 mth & mthly thereafter; BP, serum K & fluid retention mthly. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be initiated w/ Ra-223 for at least 5 days after last dose. Concomitant use w/ chemotherapy; ketoconazole. Severe renal & moderate hepatic impairment. Not to be used in severe hepatic impairment. Not to be used in women.
Adverse Reactions
HTN, peripheral edema, hypokalemia, UTI, increased aspartate &/or alanine aminotransferase.
Drug Interactions
Increased absorption w/ food. Decreased mean plasma AUC w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb. Narrow therapeutic index drugs metabolized by CYP2D6.
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.
Arabitro tab 250 mg
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