Use in pregnancy: Pregnancy Category B: Reproduction studies have been performed in rats and rabbits. Doses of Januvia up to 125 mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Januvia should be used during pregnancy only if clearly needed.
Sitagliptin administered to pregnant female rats and rabbits from gestation days 6-20 (organogenesis) was not teratogenic at oral doses up to 250 mg/kg (rats) and 125 mg/kg (rabbits), or approximately 30- and 20-times human exposure at the maximum recommended human dose (MRHD) of 100 mg/day, based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1000 mg/kg or approximately 100 times human exposure at the MRHD.
Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1000 mg/kg. No functional or behavioral toxicity was observed in offspring of rats.
Placental transfer of Sitagliptin administered to pregnant rats was approximately 45% at 2 hrs and 80% at 24 hrs post-dose. Placental transfer of Sitagliptin administered to pregnant rabbits was approximately 66% at 2 hrs and 30% at 24 hrs.
Use in lactation: Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Januvia is administered to a nursing woman.