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Pregnancy: Gemigliptin/Metformin HCl: There are no adequate and well-controlled studies in pregnant women with Gemigliptin/Metformin HCl or each components of this drug. No animal studies have been conducted with the combined products in Gemigliptin/Metformin HCl to evaluate effects on reproduction. Gemigliptin/Metformin HCl should be used during pregnancy only if clearly needed.
Gemigliptin: Reproduction studies in rats and rabbits indicated that gemigliptin was transferred to placenta and up to 48.1% and 1.6% were detected in amniotic fluids when administered to pregnant rats and rabbits, respectively, at 2 hours post dose; therefore, use of gemigliptin is not recommended during pregnancy.
Metformin: Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day, which represent 2 and 6 times the maximum recommended human daily dose of 2000 mg based on body surface area comparison 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 Gemigliptin/Metformin HCl. In animal studies, gemigliptin was excreted at a ratio of 1:4-10 in plasma and milk in lactating rats. Therefore, Gemigliptin/Metformin HCl should not be administered in nursing woman. It is not known whether gemigliptin or metformin are excreted in human milk.
