Janumet Use In Pregnancy & Lactation

SITAGLIPTIN + METFORMIN HCl (JANUMET): There are no adequate and well-controlled studies in pregnant women with SITAGLIPTIN + METFORMIN HCl (JANUMET) or its individual components; therefore, the safety of SITAGLIPTIN + METFORMIN HCl (JANUMET) in pregnant women is not known. SITAGLIPTIN + METFORMIN HCl (JANUMET), like other oral antihyperglycemic agents, is not recommended for use in pregnancy.
No animal studies have been conducted with the combined products in SITAGLIPTIN + METFORMIN HCl (JANUMET) to evaluate effects on reproduction. The following data are based on findings in studies performed with sitagliptin or metformin individually.
Sitagliptin phosphate: 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 based on the recommended daily adult human dose of 100 mg/day). Slight decreases in mean preweaning body weights of both sexes and postweaning body weight gains of males were observed in the offspring of rats given oral dose of 1000 mg/kg/day. However, animal reproduction studies are not always predictive of the human response.
Metformin hydrochloride: Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 6 times the maximum recommended human daily dose of 2,000 mg based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Nursing Mothers: No studies in lactating animals have been conducted with the combined components of SITAGLIPTIN + METFORMIN HCl (JANUMET). In studies performed with the individual components, both sitagliptin and metformin are secreted in the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk. Therefore, SITAGLIPTIN + METFORMIN HCl (JANUMET) should not be used by a woman who is nursing.