Tiglipza Plus Use In Pregnancy & Lactation

Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS): There are no adequate and well-controlled studies in pregnant women with Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS) or its individual components; therefore, the safety of Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS) in pregnant women is not known. Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS), like other oral antihyperglycemic agents, is not recommended for use in pregnancy. No animal studies have been conducted with the combined products in Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS) 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/day or in rabbits given up to 125 mg/kg/day during organogenesis (up to 32 and 22 times, respectively, the human exposure based on the recommended daily adult human dose of 100 mg). 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). Slight decreases in mean birth weight and preweaning and postweaning body weight gains were observed in the offspring of rats given sitagliptin at an oral dose of 1000 mg/kg/day from gestation day 6 to lactation day 20. However, animal reproduction studies are not always predictive of human response.
Metformin hydrochloride: Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This dose is about 3 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 phosphate + Metformin hydrochloride (TIGLIPZA PLUS). In studies performed with the individual components, both sitagliptin and metformin were excreted in the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk; some excretion of metformin in human milk has been observed. Therefore, Sitagliptin phosphate + Metformin hydrochloride (TIGLIPZA PLUS) should not be used by a woman who is nursing.