Abiratred

Abiraterone acetate

In combination w/ prednisone or prednisolone: For the treatment of newly diagnosed high risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination w/ androgen deprivation therapy (ADT); metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, or in adult men whose disease has progressed on or after docetaxel-based chemotherapy regimen.

mHSPC 1,000 mg (four 250 mg tab) once daily in combination w/ prednisone 5 mg once daily. mCRPC 1,000 mg (four 250 mg tab) as single daily dose, taken w/ low dose prednisone or prednisolone 10 mg daily.

Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals. Swallow whole w/ water.

Hypersensitivity. Severe hepatic impairment (Child-Pugh Class C). Pregnancy.

Patients w/ underlying medical conditions may be compromised by BP increase, hypokalemia, or fluid retention; severe unstable angina pectoris, recent MI or ventricular arrhythmia, severe renal impairment. History of CV disease. Consider obtaining cardiac function assessment (eg, echocardiogram) before treating patients w/ significant risk for CHF (eg, history of cardiac failure, uncontrolled HTN, or cardiac events eg, ischaemic heart disease). Correct & control HTN, hypokalemia & fluid retention. Monitor BP, serum K, fluid retention (wt gain, peripheral oedema) & other signs & symptoms of CHF every 2 wk for 3 mth then mthly thereafter. Measure serum transaminases prior to starting treatment, every 2 wk for 1st 3 mth & mthly thereafter; frequently measure blood sugar in patients w/ diabetes. Discontinue if severe hepatotoxicity (ALT or AST 20x ULN) develops. Active or symptomatic viral hepatitis. Not to be used w/ severe hepatic impairment. Monitor for adrenocortical insufficiency in patients w/drawn from prednisone or prednisolone; symptoms of mineralocorticoid excess. Decreased bone density may occur in men w/ metastatic advanced prostate cancer; anemia & sexual dysfunction in men w/ metastatic castration resistant prostate cancer including undergoing treatment. Concomitant use w/ ketoconazole, cytotoxic chemotherapy, drugs known to be associated w/ myopathy rhabdomyolysis; avoid strong inducers of CYP3A4 during treatment. Contraception is required if patient engages in sexual activity.

UTI; hypokalemia; HTN; diarrhea; peripheral oedema. Sepsis; hypertriglyceridemia; cardiac failure, angina pectoris, arrhythmia, atrial fibrillation, tachycardia; dyspepsia; increased alanine aminotransferase & aspartate aminotransferase; rash; hematuria; fractures.

Decreased mean plasma AUC w/ strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort). Increase AUC of drugs metabolised by CYP2D6 particularly w/ narrow therapeutic index (eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, tramadol). May increase conc of drugs eliminated by OATP1B1. May prolong QT interval w/ drugs known to prolong QT interval & may induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. May increase prostate stearic antigen w/ spironolactone.

Cancer Hormone Therapy

L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.

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