Galvus Met Use In Pregnancy & Lactation

Pregnancy: There are no adequate data on the use of Galvus Met in pregnant women. Animal studies have shown evidence of reproductive toxicity with high doses of vildagliptin, but no evidence of reproductive toxicity with metformin. In animal studies, there was no evidence of teratogenicity with vildagliptin and metformin, but fetotoxic effects were seen at maternally toxic doses (see Pharmacology: Toxicology: Preclinical data under Actions). The potential risk for humans is not known. Galvus Met should not be used during pregnancy.
Lactation: Animal studies have shown that both vildagliptin and metformin are excreted in the milk. It is not known whether vildagliptin passes into human milk, but small amounts of metformin are excreted in human milk. Due to the potential risk of hypoglycaemia in the neonate in connection with metformin, and due to the lack of data in humans as regards vildagliptin, Galvus Met should not be used by women who are breastfeeding (see Contraindications).