Hepatitis: The use of bicalutamide has been associated with rare cases of death or hospitalization due to severe liver injury which generally occurred within the first three to four months of treatment.
Liver function tests (bilirubin, transaminases, alkaline phosphatase) should be measured before starting bicalutamide treatment and at regular intervals for the first four months of treatment, and periodically thereafter. Measure serum transaminases (particularly serum alanine aminotransferase, ALT) immediately if clinical signs or symptoms suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness). Discontinue bicalutamide immediately and closely follow-up liver function in the event of clinical and/or biochemical evidence of severe hepatotoxicity (e.g., jaundice or an increase in serum ALT concentration greater than 2 times the upper limit of normal).
Gynecomastia and Breast Pain: Gynecomastia and breast pain have been reported in clinical trials using bicalutamide 150 mg as a single agent for prostate cancer.
Glucose Tolerance: Reduced glucose tolerance manifested as diabetes or loss of glycemic control in patients with pre-existing diabetes, has been observed in males receiving LHRH agonists. Monitor blood glucose levels in patients receiving combination therapy with bicalutamide and LHRH agonists.
Serum Prostate Specific Antigen (PSA) Monitoring: Periodic monitoring of PSA levels may be useful in assessing patient's response to therapy. A treatment-free period of antiandrogen while continuing the LHRH analog may be considered in patients who have increased PSA levels and objective disease progression.
Use in Adult Males with Liver Impairment: Although no dosage adjustment is required in patients with mild liver impairment, increased accumulation may occur in patients with moderate to severe liver impairment.
Use in Adult Males with Renal Impairment: No dosage adjustment is required in patients with renal impairment.