Use in Pregnancy: Fertility studies have been performed with vildagliptin in rats at doses producing exposures equivalent to up to 200 times the human dose and have revealed no evidence of impaired fertility or early embryonic development due to vildagliptin. Embryofetal development (teratology) studies have been conducted in rats and rabbits with the combination of vildagliptin and metformin HCl in a 1:10 ratio and produced no evidence of teratogenicity in either species. There are, however, no adequate and well-controlled studies in pregnant women and therefore, Galvus Met should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Animal studies are not always predictive of human response.
Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin monotherapy be used during pregnancy to maintain blood glucose levels as close to normal as possible.
Use in Lactation: No studies have been conducted with the combined components of Galvus Met. As it is not known whether vildagliptin and/or metformin HCl is excreted in human milk, Galvus Met should not be administered to breastfeeding women.