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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).
A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations. Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Non-clinical reproduction studies did not indicate an additive teratogenic effect attributed to the co-administration of linagliptin and metformin.
Trajenta Duo should not be used during pregnancy. If the patient plans to become pregnant, or if pregnancy occurs, treatment with Trajenta Duo should be discontinued and switched to insulin treatment as soon as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels.
Breast-feeding: Studies in animals have shown excretion of both metformin and linagliptin into milk in lactating rats. Metformin is excreted in human milk in small amounts. It is not known whether linagliptin is excreted into human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trajenta Duo 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 Duo. No adverse effects of linagliptin on fertility were observed in male or female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).
