Jardiance Duo Use In Pregnancy & Lactation

Pregnancy: There are limited data from the use of Empagliflozin + Metformin HCl (JARDIANCE DUO) or its individual components in pregnant women.
Nonclinical studies with empagliflozin alone do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 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, it is recommended to avoid the use of Empagliflozin + Metformin HCl (JARDIANCE DUO) during pregnancy unless clearly needed.
Lactation: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. 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. It is recommended to discontinue breast feeding during treatment with Empagliflozin + Metformin HCl (JARDIANCE DUO).
Fertility: No studies on the effect on human fertility have been conducted with Empagliflozin + Metformin HCl (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.