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Bicalutamide is extensively metabolised in the liver. Available data suggest that the elimination may be slower in patients with severe hepatic impairment, which may lead to increased accumulation of the substance. Therefore, caution is needed if bicalutamide is administered to patients with moderate hepatic impairment.
Monitoring of hepatic function is recommended because of potential hepatic changes. The majority of such cases occur within 4 months from the beginning of treatment.
Severe hepatic changes have been observed rarely; in such cases the treatment with bicalutamide must be discontinued.
Bicalutamide is an inhibitor of cytochrome P450 (CYP) 3A4. Caution is recommended in patients with concomitantly using substances that are metabolised predominantly by CYP 3A4.
This product contains 35 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
