Bicatero Special Precautions

Hepatitis: Rare cases of death or hospitalization because of severe liver injury have been reported during postmarketing in association with the use of bicalutamide. Hepatotoxicity in these reports generally occurred within the first 3 to 4 months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of bicalutamide patients in controlled clinical trials.
Measure serum transaminase levels prior to starting treatment with bicalutamide, at regular intervals for the first 4 months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (eg, nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like syndromes, dark urine, jaundice, or right upper quadrant tenderness), measure the serum transaminases, in particular the serum ALT, immediately. If at any time a patients has jaundice or their ALT rises above 2 times the upper limit of normal (ULN), immediately discontinue bicalutamide, with close follow-up of liver function.
Gynecomastia and breast pain: In clinical trials with bicalutamide 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.
Glucose tolerance: A reduction in glucose tolerance has been observed in men receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with preexisting diabetes. Therefore, give careful consideration to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists.
Hypersensitivity reactions: Hypersensitivity reactions, including angioneurotic edema and urticaria, have been reported.
Hepatic function impairment: Use bicalutamide with caution in patients with moderate to severe hepatic impairment. Bicalutamide is extensively metabolized by the liver. Limited data in subjects with severe hepatic impairment suggest that excretion of bicalutamide may be delayed and could lead to further accumulation. Consider periodic liver function tests for hepatically impaired patients on long-term therapy.