Bicalutamide (Casodex) 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, Casodex 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 Casodex therapy.
Severe hepatic changes and hepatic failure have been observed rarely with Casodex and fatal outcomes have been reported (see Adverse Reactions). Casodex therapy should be discontinued if changes are severe.
Bicalutamide (Casodex) has been shown to inhibit Cytochrome P450 (CYP 3A4), as such caution should be exercised when co-administered with drugs metabolised predominantly by CYP 3A4 (see Contraindications and Interactions).
Androgen deprivation therapy may prolong the QT interval, although a causal association has not been established with Casodex. In patients with a history of or who have risk factors for QT prolongation and in patients receiving concomitant medicinal products that may prolong the QT interval (see Interactions) physicians should assess the benefit risk ratio including the potential for Torsade de Pointes prior to initiating Casodex.
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 Casodex, patients and/or their partners should follow adequate contraception during and for 130 days after Casodex therapy.
50-mg: Each tablet of Casodex contains 61 mg of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
150-mg: For patients who have an objective progression of disease together with elevated PSA, cessation of Casodex therapy should be considered.
In rare cases, photosensitivity reactions have been reported for patients taking Casodex 150 mg. Patients should be advised to avoid direct exposure to excessive sunlight or UV-light while on Casodex 150 mg 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.
Lactose sensitive patients should be aware that each Casodex 150 mg tablet contains 183 mg of lactose monohydrate.
Effects on ability to drive and use machines: 50-mg: Casodex 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.
150-mg: No effects on ability to drive and use machines have been observed during treatment with Casodex 150 mg.