Abiraterone Sandoz

Abiraterone acetate

In combination w/ prednisone or prednisolone for newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men w/ androgen deprivation therapy (ADT); metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated.

1,000 mg (as four 250 mg-tab or two 500 mg-tab) as single daily dose. In combination w/ prednisone or prednisolone: mHSPC 5 mg prednisone or prednisolone daily. mCRPC 10 mg prednisone or prednisolone daily. Continue medical castration w/ LH releasing hormone (LHRH) analogue during treatment in patients not surgically castrated. Patient who develops hepatotoxicity Give reduced dose of 500 mg once daily for re-treatment following return of LFTs to patient's baseline.

Should be taken on an empty stomach: Swallow whole. Take at least 2 hr after food & do not take food at least 1 hr after administration.

Hypersensitivity. Combination w/ Ra-223. Severe hepatic impairment (Child-Pugh class C). Women who are or may potentially be pregnant.

Consider discontinuation of treatment if there is clinically significant decrease in cardiac function; marked increases in liver enzymes. Interrupt therapy immediately & closely monitor LFTs if ALT or AST rises >5x ULN. Discontinue treatment if patients develop severe hepatotoxicity (ALT or AST 20x ULN) while on therapy. Monitor patients for adrenocortical insufficiency if w/drawn from prednisone or prednisolone; symptoms of mineralocorticoid excess if treatment is continued after corticosteroids are w/drawn. HTN, hypokalaemia, fluid retention & cardiac failure due to mineralocorticoid excess. QT prolongation in patients w/ hypokalaemia. Acute liver failure & hepatitis fulminant. Decreased bone density in men w/ metastatic advanced prostate cancer. Cases of hypoglycaemia in patients w/ pre-existing diabetes receiving pioglitazone or repaglinide. Anaemia & sexual dysfunction in men w/ metastatic prostate cancer. Cases of myopathy & rhabdomyolysis. 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 & severe renal impairment); w/ history of CV disease; active or symptomatic viral hepatitis; previously treated w/ ketoconazole for prostate cancer; on controlled Na diet. Consider obtaining cardiac function assessment (eg, echocardiogram) before treating patients w/ significant risk for CHF. Monitor BP, serum K, fluid retention (wt gain, peripheral oedema), & other signs & symptoms of CHF during treatment every 2 wk for 3 mth, then mthly thereafter. Measure serum transaminase levels prior to starting treatment, every 2 wk for the 1st 3 mth, & mthly thereafter; immediately if clinical symptoms or signs suggestive of hepatotoxicity develop; blood sugar in patients w/ diabetes. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ glucocorticoids; cytotoxic chemotherapy; medicinal products associated w/ myopathy/rhabdomyolysis. Avoid use w/ strong CYP3A4 inducers due to decreased exposure. Moderate hepatic impairment (Child-Pugh class B). Not to be used in severe hepatic impairment (Child-Pugh class C). Severe renal impairment. Not to be used in women & of childbearing potential. Male patient should use condom along w/ another effective contraceptive method if engaging in sexual activity.

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

Increased absorption w/ food. Decreased mean plasma AUC w/ rifampicin. Concomitant use w/ strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort [Hypericum perforatum]); medicinal products metabolised by CYP2D6 (eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone & tramadol) & CYP2C8 (pioglitazone & repaglinide); medicinal products known to prolong QT interval or induce torsades de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, & antipsychotics. Increased systemic exposure (AUC) of dextromethorphan. May increase conc of medicinal products eliminated by OATP1B1. May increase PSA levels 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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