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Pregnancy: There are no adequate and well-controlled studies in pregnant women with TRAJENTA DUO or its individual components. Non-clinical reproduction studies in pregnant rats performed with the combined products in TRAJENTA DUO did not indicate a teratogenic effect attributed to the co-administration of linagliptin and metformin.
There are limited data from the use of linagliptin in pregnant women. Non-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
There are limited data from the use of metformin in pregnant women. Metformin was not teratogenic in rats at a dose of 200 mg/kg/day associated with 4 times human exposure. At higher doses (500 and 1000 mg/kg/day, associated with 11 and 23 times human exposure), teratogenicity of metformin was observed in the rat.
As a precautionary measure, it is preferable to avoid the use of TRAJENTA DUO during pregnancy.
When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with TRAJENTA DUO but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels.
Lactation: No studies on lactating animals have been performed with the combination of metformin and linagliptin. Non-clinical studies with the individual active substances have shown excretion of both metformin and linagliptin into milk in lactating rats. Metformin is excreted with milk in humans. It is not known whether linagliptin is excreted into human milk. TRAJENTA DUO should not be used during breast-feeding.
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 non-clinical studies up to the highest tested dose of 240 mg/kg/day (> 900 times human exposure).
