BICALUTAMIDE

Posology Adult males including the elderly:

The dosage is one 150mg tablet to be taken orally once a day. Bicalutamide Tablets 150mg should be taken continuously for at least 2 years or until disease progression.

Special populations 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). Method of administration Oral

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 Common Hot flush Respiratory, thoracic and mediastinal disorders Uncommon Interstitial lung diseasee (fatal outcomes have been reported).

Gastrointestinal disorders Common Abdominal pain Constipation Dyspepsia Flatulence Nausea Common Hepatotoxicity, jaundice, hypertransaminasaemiaa Hepato-biliary disorders Rare Hepatic failured (fatal outcomes have been reported). Very common RashSkin and subcutaneous tissue disorders Common Alopecia Hirsutism/hair re-growth Dry skinc Pruritis Rare Photosensitivity reaction Renal and urinary disorders Common Haematuria Very common Gynaecomastia and breast tendernessb Reproductive system and breast disorders Common Erectile dysfunction Very common AstheniaGeneral disorders and administration site conditions Common Chest pain Oedema Investigations Common Weight increased a.

Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy. b. The majority of patients receiving Bicalutamide Tablets 150mg as monotherapy experience gynaecomastia and/or breast pain.

In studies these symptoms were considered to be severe in up to 5% of the patients. Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment. c. Due to the coding conventions used in the EPC studies, adverse events of 'dry skin' were coded under the COSTART term of 'rash'.

No separate frequency descriptor can therefore be determined for the 150mg Bicalutamide Tablets dose however the same frequency as the 50mg dose is assumed. d. 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 Tablets arm of the 150mg EPC studies. e. Listed as an adverse drug reaction following review of post-marketed data.

Frequency has been determined from the incidence of reported adverse events of interstitial pneumonia in the randomised treatment period of the 150mg EPC studies. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Therefore, Bicalutamide Tablets 150mg 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 Tablets therapy.

8). Bicalutamide Tablets 150mg therapy should be discontinued if changes are severe. For patients who have an objective progression of disease together with elevated PSA, cessation of Bicalutamide Tablets therapy should be considered.

5). In rare cases, photosensitivity reactions have been reported for patients taking Bicalutamide Tablets 150mg. Patients should be advised to avoid direct exposure to excessive sunlight or UV-light while on Bicalutamide Tablets 150mg and the use of sunscreens may be considered.

In cases where the photosensitivity reaction is more persistent and/or severe, an appropriate symptomatic treatment should be initiated. This product contains lactose. 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 dosage unit, that is to say essentially ‘sodium-free’. 5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Bicalutamide Tablets.

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 Tablets, patients and/or their partners should follow adequate contraception during and for 130 days after Bicalutamide Tablets 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.

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