Soliqua Use In Pregnancy & Lactation

Women of childbearing potential: Insulin Glargine + Lixisenatide (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 Insulin Glargine + Lixisenatide (Soliqua), insulin glargine, or lixisenatide.
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) with insulin glargine indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity with insulin glargine. There are no adequate data from the use of lixisenatide in pregnant women. Studies with lixisenatide in animals have shown reproductive toxicity. Insulin Glargine + Lixisenatide (Soliqua) should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Insulin Glargine + Lixisenatide (Soliqua) should be discontinued.
Breast-feeding: It is unknown whether insulin glargine or lixisenatide is excreted in human milk. Insulin Glargine + Lixisenatide (Soliqua) should not be used during breast-feeding.
Fertility: Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.