Artesto

Abiraterone acetate

In combination w/ prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC) 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 (ADT) failure in whom chemotherapy is not yet clinically indicated. In combination w/ prednisone or prednisolone & ADT for newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who may have received up to 3 mth of prior ADT.

mHSPC 1,000 mg as single daily dose w/ prednisone or prednisolone 5 mg daily. mCRPC 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. Combination w/ Ra-223. Severe hepatic impairment (Child-Pugh class C). Women of childbearing potential. Pregnancy.

Discontinue use if severe hepatotoxicity develops. HTN, hypokalaemia, fluid retention; heart failure, severe or unstable angina pectoris, recent MI or ventricular arrhythmia; history of CV disease; decreased bone density. Potential risks of anaemia & sexual dysfunction. 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. Patients on controlled Na diet; previously treated w/ ketoconazole. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be initiated w/ Ra-223 for at least 5 days after last dose. Avoid concomitant use w/ strong CYP3A4 inducers. Concomitant use w/ cytotoxic chemotherapy; drugs associated w/ myopathy/rhabdomyolysis. Severe renal & moderate hepatic impairment. Not to be used in severe hepatic impairment. Men & women of childbearing potential should use effective contraception. Not to be used in women.

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

Increased absorption w/ food. Avoid use w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort (Hypericum perforatum). Increased PSA levels w/ spironolactone. Caution w/ CYP2D6-metabolised drugs eg, metoprolol, propanolol, despiramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, tramadol; drugs prolonging QT interval & inducing Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. Concomitant use w/ CYP2C8-metabolized drugs eg, pioglitazone, repaglinide.

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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