Drug Information for CASODEX (bicalutamide) TABLETS (AstraZeneca Pharnaceuticals LP): CONTRAINDICATIONS

CASODEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components.

CASODEX has no indication for women, and should not be used in this population, particularly for non-serious or non-life threatening conditions. Further, CASODEX should not be used by women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. CASODEX may cause fetal harm when administered to pregnant women. The male offspring of rats receiving doses of 10 mg/kg/day (plasma drug concentrations in rats equal to approximately 2/3 human therapeutic concentrations*) and above were observed to have reduced anogenital distance and hypospadias in reproductive toxicology studies. These pharmacological effects have been observed with other antiandrogens. No other teratogenic effects were observed in rabbits receiving doses up to 200 mg/kg/day (approximately 1/3 human therapeutic concentrations*) or rats receiving doses up to 250 mg/kg/day (approximately 2 times human therapeutic concentrations*).

*Based on a maximum dose of 50 mg/day of bicalutamide for an average 70 kg patient.