50 mg: Advanced prostate cancer in combination w/ LH releasing hormone (LHRH) analogue therapy or surgical castration. 150 mg: Locally advanced prostate cancer (T3-T4, any N, MO; T1-T2, N+, MO), as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or RT. Management of patients w/ locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.
Adult male including the elderly50 mg 1 tab once daily. Start treatment at least 3 days before commencing treatment w/ an LHRH analogue or at the same time as surgical castration. 150 mg 1 tab once daily taken continuously for at least 2 yr or until disease progression.
Consider periodic liver function testing. Discontinue therapy if severe hepatic changes & hepatic failure occur. Co-administration w/ drugs metabolized by CYP3A4. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Androgen therapy may prolong QT interval. Patient w/ history of or risk factors for QT prolongation, receiving medicinal products that may prolong QT interval; assess the benefit-risk ratio including potential for Torsade de Pointes prior to initiation of therapy. Follow adequate contraception during & for 130 days after therapy. Increased prothrombin time (PT), INR & risk of bleeding w/ coumarin anticoagulants. Close monitoring of PT/INR & anticoagulant dose adjustment. May impair ability to drive & use machines. Moderate to severe hepatic impairment. Not to be given during pregnancy. Subfertility or infertility in males. 50 mg: Monitor blood glucose in patients receiving concomitant LHRH agonists. 150 mg: Consider cessation of therapy in patients w/ objective progression of disease together w/ elevated PSA. Avoid direct exposure to sunlight or UV light & consider use of sunscreen. Lactose-sensitive patients.
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