Bicalutamide is extensively metabolized 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, Casodex/Casodex 150 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/Casodex 150 therapy.
Severe hepatic changes have been observed rarely with Casodex/Casodex 150 (see Adverse Reactions). Casodex/Casodex 150 therapy should be discontinued if changes are severe.
For patients who have an objective progression of disease together with elevated PSA, cessation of Casodex/Casodex 150 therapy should be considered.
Bicalutamide has been shown to inhibit cytochrome P-450 (CYP3A4), as such, caution should be exercised when co-administered with drugs metabolized predominantly by CYP3A4 (see Contraindications and Interactions).
Lactose-sensitive patients should be aware that each Casodex 150 tablet contains 183 mg of lactose monohydrate (see Contraindications).
Effects on the Ability to Drive or Operate Machinery: No effects on ability to drive and use machines have been observed during treatment with Casodex/Casodex 150.