Reproduction studies, conducted in male and female
rats, found no evidence of impaired fertility or reproductive performance at oral doses approximately 15 times the maximum human dose on a mg/m2 basis (MHD) (1). No teratogenic effects were observed in rats, rabbits, and monkeys at oral doses approximately 6, 4, and 3 times, respectively, the MHD, although maternal toxicity was evident at these dose levels.