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No clinical studies have been conducted to date to evaluate trelagliptin in subjects who are pregnant or lactating. In animal studies, no embryo-fetal toxicity or pre- and postnatal toxicity was observed at dose of up to 300 mg/kg/day in rats and no embryo-fetal toxicity was observed at doses of up to 250 mg/kg/day in rabbits (approximately 31- and 60- fold, respectively, the clinical AUC24 (SYR-472/CPH-002)). Placental transfer of trelagliptin was observed in pregnant rats.
It is unknown if trelagliptin is excreted in human milk. In animal study, trelagliptin was secreted in the milk of lactating rats.
As a precaution, trelagliptin should not be administered to women who are or may be pregnant, unless the expected therapeutic benefit is thought to outweigh any possible risk.
During the treatment with trelagliptin, nursing should be avoided if the administration of this drug is necessary for the mother.
