Abiratred

Abiraterone acetate

W/ prednisone or prednisolone for metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated & whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

1,000 mg as single daily dose (four 250-mg tab) + prednisone or prednisolone 10 mg daily. Re-treatment in patient who develops hepatotoxicity during treatment Reduce dose to 500 mg (2 tab) once 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 who are or may potentially be pregnant.

Patients whose underlying medical conditions might be compromised by increases in BP, hypokalaemia (eg, those on cardiac glycosides), or fluid retention (eg, those w/ heart failure), severe or unstable angina pectoris, recent MI or ventricular arrhythmia & w/ severe renal impairment; w/ 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 & correct abnormalities. Measure serum transaminase levels prior to starting treatment, every 2 wk for 1st 3 mth of treatment, & mthly thereafter; blood sugar frequently in patients w/ diabetes. Discontinue treatment 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 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; medicinal products known to be associated w/ myopathy/rhabdomyolysis. Skeletal muscle effects eg, myopathy, rhabdomyolysis w/ renal failure. Avoid strong inducers of CYP3A4 during treatment. Contraception is required if patient engages in sexual activity. Condom is required if patient is engaged in sexual activity w/ pregnant woman. Condom is required along w/ another effective contraceptive method if patient is engaged in sex w/ woman of childbearing potential. Not for use in breastfeeding.

UTI; hypokalaemia; HTN; diarrhoea; peripheral oedema. Sepsis; hypertriglyceridaemia; cardiac failure, angina pectoris, arrhythmia, atrial fibrillation, tachycardia; dyspepsia; increased ALT/AST; rash; haematuria; fractures.

Decreased mean plasma AUC w/ strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St John's wort). Increased AUC of dextromethorphan; drugs metabolised by CYP2D6 particularly w/ narrow therapeutic index (eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone & tramadol). Monitor for signs of toxicity w/ pioglitazone. May increase conc of drugs eliminated by OATP1B1. May prolong QT interval w/ medicinal products known to prolong QT interval or able to induce Torsade de pointes eg, class IA (quinidine, disopyramide) or III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. May increase PSA & not recommended 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.

Rx