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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 breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
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).
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