Jimvia Use In Pregnancy & Lactation

Sitagliptin was not teratogenic in rats at oral doses up to 250 mg/kg or in rabbits given up to 125 mg/kg during organogenesis (up to 32 and 22 times, respectively, the human exposure based on the recommended daily adult human dose of 100 mg/day). In rats, a slight increase in the incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) was observed at oral doses of 1000 mg/kg/day (approximately 100 times the human exposure bases on the recommended daily adult human dose of 100 mg/day). Slight decrease in mean preweaning body weight of both sexes and postweaning body weight gains of males were observed in the offering of rats given oral dose of  1000 mg/kg/day. However, animal reproduction studies are not always predictive of the human response.
There are no adequate and well-controlled studies in pregnant; therefore, the safety of sitagliptin in pregnant women is not known. Sitagliptin, like other oral antihyperglycemic agents, is not recommended for use in pregnancy.
It is not known if sitagliptin is excreted in breast milk. Caution should be exercised when administering sitagliptin to breast-feeding women.