Pregnancy: There are limited data from the use of JARDIANCE DUO or its individual components in pregnant women.
Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extend but do not indicate direct or indirect harmful effects with respect to early embryonic development. However, animal studies have shown adverse effects on postnatal development.
Animal studies with the combination of empagliflozin and metformin or with metformin alone have shown reproductive toxicity at higher doses of metformin only (see Pharmacology: Toxicology under Actions).
As a precautionary measure, JARDIANCE DUO is not recommended during pregnancy. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with JARDIANCE DUO but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Lactation: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants; however only limited data are available. It is unknown whether empagliflozin is excreted in human milk. Available nonclinical data in animals have shown excretion of empagliflozin in milk.
A risk to human newborns/infants cannot be excluded. This medicinal product should not be used during breast feeding.
Fertility: No studies on the effect on human fertility have been conducted with JARDIANCE DUO or its individual components.
Non-clinical studies in animals with the individual components do not indicate direct or indirect harmful effects with respect to fertility.