Dr. Reddy's Lab


Concise Prescribing Info
Abiraterone acetate
In combination w/ prednisone or prednisolone for metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after docetaxel-based chemotherapy regimen; in asymptomatic or mildly symptomatic adult men after androgen deprivation therapy failure in whom chemotherapy is not yet clinically indicated.
Dosage/Direction for Use
1,000 mg as single daily dose w/ prednisone or prednisolone 10 mg daily.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole w/ water.
Hypersensitivity. Severe hepatic impairment (Child-Pugh class C). Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue use if severe hepatotoxicity develops. HTN, hypokalaemia, fluid retention; severe or unstable angina pectoris, recent MI or ventricular arrhythmia; history of CV disease; decreased bone density; anemia, sexual dysfunction. Hyperglycaemia. Measure serum transaminases prior to, every 2 wk for 1st 3 mth & mthly thereafter. Monitor BP, serum K & fluid retention mthly. Measure blood sugar in diabetic patients frequently. Corticosteroid w/drawal & unusual stress. Avoid use w/ strong CYP3A4 inducers. Patients previously treated w/ ketoconazole. Concomitant use w/ cytotoxic chemotherapy, drugs associated w/ myopathy/rhabdomyolysis. Severe renal & moderate hepatic impairment. Not to be used in severe hepatic impairment. Not to be used in women.
Adverse Reactions
UTI; hypokalaemia; HTN; diarrhoea; peripheral oedema. Sepsis; hypertriglyceridaemia; cardiac failure, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; increased ALT &/or AST; rash; haematuria; fractures (except pathological fracture).
Drug Interactions
Increased absorption w/ food. Avoid use w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort. Drugs prolonging QT interval & inducing Torsade de pointes eg, class IA or III antiarrhythmics, methadone, moxifloxacin, antipsychotics. Increased prostate specific antigen levels w/ spironolactone. CYP2D6 & CYP2C8 inhibitors. CYP2D6-metabolised drugs eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, tramadol.
MIMS Class
Cancer Hormone Therapy
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.
Abiratred FC tab 250 mg
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