Abiraterone Teva

Abiraterone Teva



Teva Pharma


Concise Prescribing Info
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; 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.
Dosage/Direction for Use
Adult mHSPC 1,000 mg (as four 250 mg tab) as a single daily dose + 5 mg prednisone or prednisolone daily. mCRPC 1,000 mg (as four 250 mg tab) as a single daily dose + 10 mg prednisone or prednisolone daily. Medical castration w/ luteinising hormone releasing hormone analogue should be continued during treatment in patients not surgically castrated. Patients who develop hepatotoxicity during treatment Re-treatment following return of liver function's test to baseline: 500 mg (one tab) once daily.
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals. Swallow whole w/ water.
Hypersensitivity. Severe hepatic impairment (Child-Pugh Class C). Concomitant use w/ Ra-223. Pregnancy.
Special Precautions
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 & those w/ severe renal impairment). History of CV disease. Patients w/ left ventricular ejection fraction <50% or NYHA Class III or IV heart failure. Assess cardiac function (eg, echocardiogram) prior to treatment in patients w/ significant risk for CHF. Monitor BP, serum K, fluid retention (wt gain, peripheral oedema) & other signs & symptoms of CHF every 2 wk for 3 mth, then mthly thereafter. Measure serum transaminase levels prior to starting treatment every 2 wk for the first 3 mth of treatment & mthly thereafter. Interrupt treatment immediately if ALT or AST rises >5 x ULN & closely monitor liver function. Discontinue treatment if severe hepatotoxicity (ALT or AST 20 x ULN) develops & do not re-treat. Active or symptomatic viral hepatitis. Moderate or severe hepatic impairment (Child-Pugh Class B or C). Monitor for adrenocortical insufficiency if patients are w/drawn from prednisone or prednisolone. Decreased bone density in men w/ metastatic advanced prostate cancer. Patients previously treated w/ ketoconazole. Frequently measure blood sugar in patients w/ diabetes. Anemia & sexual dysfunction may occur. Concomitant use w/ cytotoxic chemotherapy, strong CYP3A4 inducers, & drugs known to be associated w/ myopathy/rhabdomyolysis. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Do not initiate treatment w/ Ra-223 for at least 5 days after the last administration therapy. Not for use in women. Contraception is required if engage in sexual activity.
Adverse Reactions
UTI; hypokalaemia; HTN; diarrhea; increased ALT &/or AST; peripheral oedema. Sepsis, hypertriglyceridaemia; cardiac failure, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; rash; haematuria; fractures.
Drug Interactions
Increased absorption w/ food. Decreased AUCw/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort (Hypericum perforatum). Increase AUC of dextromethorphan. Drugs metabolised by CYP2D6 particularly w/ drugs that have narrow therapeutic index eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone & tramadol. Drugs known to prolong the 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 prostate specific antigen w/ spironolactone.
ATC Classification
L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.
Abiraterone Teva FC tab 250 mg
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