Advanced prostate cancer in combination w/ LH-releasing hormone (LHRH) analogue therapy or surgical castration. Monotherapy or as adjuvant to radical prostatectomy or RT in patients w/ locally advanced prostate cancer at high risk for disease progression.
Adult including elderly 50 mg once daily either 3 days before or at the same time w/ LHRH analogue or surgical castration. Monotherapy 150 mg once daily taken continuously for at least 2 yr or until progression.
Consider periodic LFT due to the possibility of hepatic changes. Reduced glucose tolerance. Monitor blood glucose in patients receiving therapy in combination w/ LHRH agonists. May prolong the QT interval. Patients &/or their partners should follow adequate contraception during & for 130 days after bicalutamide therapy. Somnolence may occur. Co-administration w/ CYP3A4, coumarin anticoagulants. Moderate to severe hepatic impairment.
Increased AUC of midazolam. Terfenadine, astemizole, cisapride, Ca channel blockers. Closely monitor w/ ciclosporin. Other medicinal products inhibiting drug oxidation eg, cimetidine & ketoconazole. Increased effect of warfarin & other coumarin anticoagulants. Medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
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