Abiraterone 250 Eurodrug

Abiraterone acetate

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 (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; mCRPC in adult men whose disease has progressed on or after docetaxel-based chemotherapy regimen.

mHSPC 1,000 mg (four 250 mg tab) as single daily dose + 5 mg prednisone or prednisolone daily. mCRPC 1,000 mg (four 250 mg tab) as single daily dose + 10 mg prednisone or prednisolone daily. Medical castration w/ LH-releasing hormone analogue should be continued during treatment in patients not surgically castrated. Patients who develop hepatotoxicity during treatment Re-treatment following return of LFTs to baseline: 500 mg (2 tab) 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. Withhold treatment in patients who develop Grade ≥3 toxicities including HTN, hypokalaemia, oedema & other non-mineralocorticoid toxicities. Interrupt treatment immediately if ALT or AST rises >5x ULN & closely monitor LFT. Consider discontinuation of treatment if there is clinically significant decrease in cardiac function. QT prolongation in patients experiencing hypokalaemia; decreased bone density; increased hyperglycaemia; risk of anaemia & sexual dysfunction; myopathy & rhabdomyolysis. Patients w/ medical conditions that might be compromised by increases in BP, hypokalaemia (eg, patients on cardiac glycosides), or fluid retention (eg, those w/ heart failure, severe or unstable angina pectoris, recent MI or ventricular arrhythmia & severe renal impairment); history of CV disease; previous ketoconazole treatment (lower response rate). Obtain assessment of cardiac function (eg, echocardiogram) before treating patients w/ significant risk for CHF. Correct & control HTN, hypokalaemia & fluid retention before treatment. 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. Monitor for adrenocortical insufficiency if patients are w/drawn from prednisone or prednisolone; symptoms of mineralocorticoid excess if treatment is continued after corticosteroid w/drawal. Measure serum transaminase levels prior to treatment initiation, every 2 wk for the 1st 3 mth of treatment, & mthly thereafter or immediately if clinical symptoms or signs suggestive of hepatotoxicity develop; blood sugar in patients w/ diabetes. Concomitant use w/ glucocorticoid; cytotoxic chemotherapy; medicinal products associated w/ myopathy/rhabdomyolysis. Avoid concomitant use w/ strong CYP3A4 inducers. Not to initiate Ra-223 for at least 5 days after last abiraterone administration w/ prednisone/prednisolone. Not to be taken by patients w/ galactose intolerance, Lapp 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). Acute liver failure & fulminant hepatitis. Severe renal impairment w/ prostate cancer. Not for use in women & of childbearing potential. Use condom if engaging in sexual activity w/ pregnant women; w/ woman of childbearing potential together w/ another effective contraceptive method. Paed patients.

UTI; hypokalaemia; HTN; diarrhoea; increased ALT/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 activated by or metabolised by CYP2D6, particularly w/ narrow therapeutic index eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone & tramadol; CYP2C8 substrate w/ narrow therapeutic index eg, pioglitazone & repaglinide; medicinal products prolonging QT interval or those able to induce torsades de pointes eg, class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. Increased AUC of dextromethorphan; pioglitazone. 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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