Soliqua Use In Pregnancy & Lactation

Women of childbearing potential: Soliqua is not recommended in women of childbearing potential not using contraception.
Pregnancy: There is no clinical data on exposed pregnancies from controlled clinical studies with use of Soliqua, insulin glargine, or lixisenatide.
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) with insulin glargine indicate no malformative nor foeto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity with insulin glargine.
There are no or limited amount of data from the use of lixisenatide in pregnant women. Studies with lixisenatide in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Soliqua is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether insulin glargine or lixisenatide are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Soliqua.
Fertility: Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.