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Pregnancy: Limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in a pre-and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the MRHD. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Lactation: It is not known if febuxostat is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when administering febuxostat to breastfeeding women.
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