Lantus Use In Pregnancy & Lactation

Pregnancy: There are no randomized controlled clinical studies of the use of insulin glargine in pregnant women.
A large number (more than 1000 retrospective and prospective pregnancy outcomes) of exposed pregnancies from Post Marketing Surveillance indicate no specific adverse effects of insulin glargine 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 insulin glargine 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 up to 6 to 40 times the human doses, do not indicate direct harmful effects on the pregnancy.
The use of Lantus may be considered during pregnancy, if necessary.
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.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). 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: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breast-feeding women may require adjustments in insulin dose and diet.
Fertility: Animal studies do not indicate direct harmful effects with respect to fertility.