Ezentia Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
No evidence of embryolethal effects with 250, 500, 1000 mg/kg/day (during organogenesis) has been reported in rats and rabbits. In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were reported at 1000 mg/kg/day (~10 X the human exposure at 10 mg daily based on AUC_0-24hr for total ezetimibe). In rabbits, an increased incidence of extra thoracic ribs was reported at 1000 mg/kg/day ezetimibe (150 X the human exposure at 10 mg daily based on AUC_0-24hr for total ezetimibe). Ezetimibe crossed the placenta in pregnant rats and rabbits.
Higher ezetimibe and statin exposures have been reported in rats and rabbits on ezetimibe and statins combination during organogenesis. Reproductive findings have been reported at lower doses in combination therapy vs monotherapy.
Lactation: All statins are contraindicated in pregnant and nursing women. When ezetimibe is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and prescribing information for the statin (see Contraindications).
It is not known whether ezetimibe is excreted into human breast milk. In rat, exposure to total ezetimibe in nursing pups was up to half of that reported in maternal plasma. Because many drugs are excreted in human milk, caution should be exercised when ezetimibe is administered to a nursing woman. Ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.