Fexoxan Use In Pregnancy & Lactation

Pregnancy: Risk summary: Limited available data with FEBUXOSTAT use in pregnant woman are insufficient to inform a drug associated risk of adverse development outcomes. No adverse developmental effects were observed in embryo-fetal developmental 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 (MHRD). 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 MHRD (see Data as follows).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data: Animal Data: In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation Days 7-17, febuxostat was not teratogenic and did not affect fetal development or survival at exposure up to approximately 40 times the MHRD (on an AUC basis at maternal oral doses up to 48 mg/kg/day). In an embryo-fetal developmental study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6-18, febuxostat was not teratogenic and did not affect fetal development at exposure up to approximately 51 times the MHRD (on an AUC basis at maternal oral doses of 12 mg/kg/day).
Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.
Lactation: Risk Summary: There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. Febuxostat is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FEBUXOSTAT and any potential adverse effects on the breastfed child from FEBUXOSTAT or from the underlying maternal condition.
Data: Animal Data: Orally administered febuxostat was detected in the milk of lactating rats up to approximately 7 times the plasma concentration.