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BICALUTAMIDE is a brand name for Bicalutamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bicalutamide 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1). Bicalutamide 150 mg is also indicated for the management of patients with locally advanced, non-metastatic…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adult males including the elderly:
The dosage is one 150 mg tablet to be taken orally once a day. Bicalutamide 150 mg 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).
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 Rash Common Alopecia Hirsutism/hair re-growth Dry skinc Pruritus Skin and subcutaneous tissue disorders Rare Photosensitivity reaction Renal and urinary disorders Common Haematuria Very common Gynaecomastia and breast tendernessbReproductive 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 150 mg 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 150 mg bicalutamide dose however the same frequency as the 50 mg 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 arm of the 150 mg EPC studies.
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. For patients who have an objective progression of disease together with elevated PSA, cessation of bicalutamide therapy should be considered. 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). In rare cases, photosensitivity reactions have been reported for patients taking bicalutamide. Patients should be revised to avoid direct exposure to excessive sunlight or UV-light while on bicalutamide 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. 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.
6). 1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 150 mg 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.
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’.