Can EXJADE be taken during pregnancy?
EXJADE has received an FDA pregnancy Category B rating. Reproduction studies have been performed in pregnant rats at oral doses up to 100 mg/kg per day (about 0.8 times the recommended human oral dose based on body surface area), and in pregnant rabbits at oral doses up to 50 mg/kg per day (about 0.8 times the recommended human oral dose based on body surface area). These studies have revealed no evidence of impaired fertility or harm to the fetus due to deferasirox. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, deferasirox should be used during pregnancy only if clearly needed.
