Trajenta Use In Pregnancy & Lactation

Pregnancy: The use of linagliptin has not been studied in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Trajenta during pregnancy.
Breast-feeding: Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk. 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.
It is not known whether this drug is excreted in human milk. Caution should be exercised when TRAJENTA is administered to a nursing woman.
Fertility: No studies on the effect on human fertility have been conducted for Trajenta. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).