ProglinMet Use In Pregnancy & Lactation

Pregnancy: Risk summary: There is insufficient experience with vildagliptin + metformin (ProglinMet) in pregnant women. Embryo-fetal development (teratology) studies have been conducted in rats and rabbits with the combination of vildagliptin and metformin hydrochloride in a 1:10 ratio and produced no evidence of teratogenicity in either species. There is insufficient experience with vildagliptin + metformin (ProglinMet) in pregnant women. Therefore, it 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.
Lactation: Risk summary: No studies have been conducted with the combined components. Metformin is excreted into human breast milk. It is not known whether vildagliptin is excreted in human milk or not. It should not be administered to breast-feeding women.
Females and males of reproductive potential: No studies on the effect on human fertility have been conducted for vildagliptin + metformin (ProglinMet). 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. Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.