Abiraterone 500 Eurodrug

Combination therapy w/ prednisone or prednisolone for newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination w/ androgen deprivation therapy; 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; mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

mHSPC 1,000 mg (two 500 mg tab) as single daily dose + 5 mg prednisone or prednisolone daily. mCRPC 1,000 mg (two 500 mg tab) as single daily dose + 10 mg prednisone or prednisolone daily. Patients not surgically castrated Continue medical castration w/ LH releasing hormone analogue during treatment. Patients who develop hepatotoxicity during treatment Re-treatment following return of LFTs to baseline: 500 mg once daily.

Should be taken on an empty stomach: Swallow whole w/ water.

Hypersensitivity. Concomitant use w/ Ra-223. Severe hepatic impairment (Child-Pugh class C). Pregnancy.

Discontinue treatment if patients develop severe hepatotoxicity (ALT or AST 20x ULN) while on therapy & should not be re-treated; if hepatotoxicity recurs at reduced dose of 500 mg daily. Consider discontinuation of treatment if there is clinically significant decrease in cardiac function. W/hold treatment & not to be reinitiated until symptoms resolved to Grade 1 or baseline for patients who develop Grade ≥3 toxicities including HTN, hypokalaemia, oedema & other non-mineralocorticoid toxicities. Interrupt treatment immediately & closely monitor liver function if ALT or AST increases >5x ULN. Monitor & correct BP, serum K, fluid retention (wt gain, peripheral oedema), & other signs & symptoms of CHF every 2 wk for 3 mth, then mthly thereafter. Monitor for adrenocortical insufficiency if patients are w/drawn from prednisone or prednisolone; symptoms of mineralocorticoid excess if treatment is continued after corticosteroids are w/drawn; blood sugar in patients w/ diabetes. Myopathy & rhabdomyolysis; hypo-/hyperglycaemia; QT prolongation; acute liver failure & fulminant hepatitis. Anaemia & sexual dysfunction; decreased bone density. Patients w/ active or symptomatic viral hepatitis; 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/ history of CV disease; w/ left ventricular ejection fraction <50% or NYHA Class II-IV heart failure; on controlled Na diet. Measure serum transaminases prior to starting treatment, every 2 wk for the 1st 3 mth, & mthly thereafter; if clinical symptoms or signs suggestive of hepatotoxicity develop. Maintain K level at ≥4.0 mM in patients w/ pre-existing hypokalaemia or those who develop hypokalaemia while on treatment. Consider obtaining assessment of cardiac function (eg, echocardiogram) before treating patients w/ significant risk for CHF (eg, history of cardiac failure, uncontrolled HTN, or cardiac events eg, ischaemic heart disease). Treat cardiac failure & optimize cardiac function before treatment. May increase corticosteroid dose before, during & after stressful situation in patients on prednisone or prednisolone who are subjected to unusual stress. Not to initiate subsequent treatment w/ Ra-223 for at least 5 days after last administration in combination w/ prednisone/prednisolone. Avoid strong CYP3A4 inducers during treatment. Lower response rates in patients previously treated w/ ketoconazole. Concomitant treatment w/ medicinal products known to be associated w/ myopathy/rhabdomyolysis; cytotoxic chemotherapy. Not to be used in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not to be used in severe hepatic impairment (Child-Pugh class C). Moderate hepatic impairment (Child-Pugh class B). Severe renal impairment. Patient should use condom prior to engaging in sexual activity w/ pregnant woman & along w/ another effective contraceptive method if engaging in sexual activity w/ woman of childbearing potential. Not for use in women. No relevant use in paed patients.

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

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

Cancer Hormone Therapy

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

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