Biluron 50 Special Precautions

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 patients 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.
Severe hepatic changes and hepatic failure have been observed rarely with Bicalutamide, and fatal outcomes have been reported (see Adverse Reactions).
Bicalutamide therapy should be discontinued if changes are severe. A reduction in glucose tolerance has been observed in males receiving LHRH agonist. 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 agonist.
Bicalutamide has been shown to inhibit cytochrome P450 (CYP3A4), as such caution should be exercised when co-administrated with drugs metabolised predominantly by CYP3A4 (see Contraindications and Interactions).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Androgen deprivation therapy may prolong the QT interval, although a causal association has not been established with Bicalutamide. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see Interactions) 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 results in increased Prothrombin Time (PT) and International Normalised Ratio (INR). Some cases have been associated with risk of bleeding. Close monitoring of PT/INR is advised and anticoagulant dose adjustment should be considered (see Interactions and Adverse Reactions).
Effects on ability to drive and use machines: Bicalutamide is unlikely to impair the ability of patients to drive or operate machinery. However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise caution.