BICALUTAMIDE

Posology Adult males including the elderly: one tablet (50 mg) once a day Treatment with bicalutamide should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. Renal impairment: no dosage adjustment is necessary for patients with renal impairment.

Hepatic impairment: no dosage adjustment is necessary for patients with mild hepatic impairment. 4). 3).

In this section, undesirable effects are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

5). Vascular disorders Very common Hot flush Respiratory, thoracic and mediastinal disorders Uncommon Interstitial lung disease5 (fatal outcomes have been reported). Very common Abdominal pain, constipation, nausea Gastrointestinal disorders Common Dyspepsia, flatulence Common Hepatotoxicity, jaundice, hypertransaminasaemia1 Hepatobiliary disorders Rare Hepatic failure 2 (fatal outcomes have been reported).

Common Alopecia, hirsutism/hair re-growth, rash, dry skin, pruritus Skin and subcutaneous tissue disorders Rare Photosensitivity reaction Renal and urinary disorders Very common Haematuria Very common Gynaecomastia and breast tenderness3 Reproductive system and breast disorders Common Erectile dysfunction Very common Asthenia, oedemaGeneral disorders and administration site conditions Common Chest pain Investigations Common Weight increased 1.

Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy. 2. Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of hepatic failure in patients receiving treatment in the open-label bicalutamide arm of the 150 mg EPC studies.

3. May be reduced by concomitant castration. 4. Observed in a pharmaco-epidemiology study of LHRH agonists and anti- androgens used in the treatment of prostate cancer. The risk appeared to be increased when Bicalutamide 50 mg was used in combination with LHRH agonists, but no increase in risk was evident when Bicalutamide 150 mg was used as a monotherapy to treat prostate cancer.

Initiation of treatment should be under the direct supervision of a specialist. Bicalutamide is extensively metabolised in the liver. Data suggests that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide.

Therefore, bicalutamide should be used with caution in patients with moderate to severe hepatic impairment. Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of changes are expected to occur within the first 6 months of bicalutamide therapy.

8). Bicalutamide therapy should be discontinued if changes are severe. A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes.

Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists. 5). Androgen deprivation therapy may prolong the QT interval. 5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating bicalutamide.

Antiandrogen therapy may cause morphological changes in spermatozoa. Although the effect of bicalutamide on sperm morphology has not been evaluated and no such changes have been reported for patients who received bicalutamide, patients and/or their partners should follow adequate contraception during and for 130 days after bicalutamide therapy.

Potentiation of coumarin anticoagulant effects have been reported in patients receiving concomitant bicalutamide therapy, which may result in increased Prothrombin Time (PT) and International Normalised Ratio (INR). Some cases have been associated with risk of bleeding.

8). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

6). 1. 5).