Toujeo Use In Pregnancy & Lactation

Pregnancy: There are no randomized controlled clinical studies of the use of Toujeo in pregnant women. A large number (more than 1000 retrospective and prospective pregnancy outcomes with Lantus) of exposed pregnancies from Post Marketing Surveillance indicate no specific adverse effects on pregnancy or on the health of the foetus and newborn child. Furthermore a meta-analysis of eight observational clinical studies including 331 women using Lantus and 371 women using insulin NPH was performed to assess the safety of insulin glargine and insulin NPH in gestational or pregestational diabetes. No significant differences in safety-related maternal or neonatal outcomes were seen between insulin glargine and insulin NPH during pregnancy.
Animal studies, with doses of insulin glargine 100 U/mL up to 6 to 40 times the human doses, do not indicate direct harmful effects on the pregnancy.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycemia. The use of Toujeo may be considered during pregnancy, if clinically needed.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly.
Careful monitoring of glucose control is essential in such patients.
Patients with diabetes must inform their doctor if they are pregnant or are contemplating pregnancy.
Lactation: Lactating women may require adjustments in insulin dose and diet.