Combination therapy w/ 50 mg: Advanced prostate cancer in combination w/ LH-releasing hormone (LHRH) analogue therapy or surgical castration. Monotherapy w/ 150 mg: Monotherapy or as adjuvant to radical prostatectomy or RT in patients w/ locally advanced prostate cancer at high risk for disease progression.
Adult male including the elderlyCombination therapy 50 mg once daily, may be started either 3 days before or at the same time as LHRH analogue or surgical castration. Monotherapy 150 mg once daily taken continuously for at least 2 yr or until disease progression.
Discontinue use if hepatic changes are severe. May prolong QT interval. Consider periodic LFT; monitoring of blood glucose in patients receiving treatment in combination w/ LHRH agonists. Co-administration w/ medicinal products metabolised predominantly by CYP 3A4; coumarin anticoagulants. Somnolence may occur which may affect ability to drive & use machines. Moderate to severe hepatic impairment. Patients &/or their partners should follow adequate contraception during & for 130 days after therapy. Assume a period of sub-fertility or infertility in man. Contraindicated during lactation.
Increased AUC of midazolam. Concomitant use w/ medicinal products w/ narrow therapeutic index eg, ciclosporin & Ca channel blockers; medicinal products known to prolong QT interval or able to induce torsade de pointes eg, class IA (eg, quinidine, disopyramide) or III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. Plasma conc may be increased w/ other medicinal products which may inhibit drug oxidation eg, cimetidine & ketoconazole. Increased effect of warfarin & other coumarin anticoagulants.
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