Pregnancy: There are limited data from the use of linagliptin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of TRAJENTA during pregnancy.
Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of linagliptin/metabolites in milk. A risk to the newborns/infants cannot be excluded. TRAJENTA should not be used during breast-feeding.
Fertility: No studies on the effect on human fertility have been conducted for TRAJENTA. No adverse effects on fertility were observed in animals up to the highest dose of 240 mg/kg/day (approximately 943 times human exposure based on AUC comparisons).