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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 specific adverse effects of insulin glargine on pregnancy and no specific malformative nor foeto/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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Soliqua should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Soliqua should be discontinued.
Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/day highest clinical dose, respectively, based on plasma AUC [see Pharmacology: Toxicology: Preclinical safety data under Actions].
Breast-feeding: It is unknown whether insulin glargine or lixisenatide is excreted in human milk. 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.
