Biluron 50

Advanced prostate cancer in combination w/ LHRH analogue therapy or surgical castration.

Adult male including the elderly 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.

May be taken with or without food.

Hypersensitivity. Co-administration w/ terfenadine, astemizole or cisapride. Lactation. Females. Childn.

Consider periodic LFT due to the possibility of hepatic changes; discontinue if changes are severe. Monitor blood glucose in patients receiving concomitant LHRH agonists. Co-administration w/ drugs metabolised predominantly by CYP3A4. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 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 Torsades 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. Consider close monitoring of PT/INR & anticoagulant dose adjustment. May impair ability to drive or operate machinery; occasional somnolence may occur. Moderate to severe hepatic impairment. Not to be given during pregnancy. Subfertility or infertility in males.

Anemia; dizziness; hot flush; abdominal pain, constipation, nausea; haematuria; gynaecomastia, breast tenderness; asthenia, oedema. Decreased appetite; decreased libido, depression; somnolence; MI, cardiac failure; dyspepsia, flatulence; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism/hair re-growth, dry skin, pruritus, rash; erectile dysfunction; chest pain; increased wt.

Increased mean midazolam exposure (AUC). Increased AUC w/ drugs w/ a narrow therapeutic index (eg, terfenadine, astemizole & cisapride, cyclosporin & Ca-channel blockers. Increased plasma conc w/ other inhibitor oxidation drug eg, cimetidine & ketoconazole. Increased effect of warfarin & other coumarin anticoagulants.

Cancer Hormone Therapy

L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

K