DRUG INTERACTIONS
Drug/Food Interactions
The bioavailability (AUC) of deferasirox was variably increased when taken with a meal. Deferasirox should be taken on an empty stomach 30 minutes before eating.
Exjade tablets for oral suspension can be dispersed in water, orange juice, or apple juice.
Carcinogenicity/Mutagenesis/Impairment of Fertility
A 104-week oral carcinogenicity study in Wistar rats showed no evidence of carcinogenicity from deferasirox at doses up to 60 mg/kg per day (about 0.48 times the recommended human oral dose based on body surface area). A 26-week oral carcinogenicity study in p53 (+/-) transgenic mice has shown no evidence of carcinogenicity from deferasirox at doses up to 200 mg/kg per day (about 0.81 times the recommended human oral dose based on body surface area) in males and 300 mg/kg per day (about 1.21 times the recommended human oral dose based on body surface area) in females.
Deferasirox was negative in the Ames test and chromosome aberration test with human peripheral blood lymphocytes. It was positive in 1 of 3 in vivo oral rat micronucleus tests.
Deferasirox at oral doses up to 75 mg/kg per day (about 0.6 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male and female rats.
Pregnancy
Teratogenic Effects: Pregnancy Category B
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.
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