ABASAGLAR® (insulin glargine): Use in pregnancy

Information from the label

For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.¹

Animal data do not indicate reproductive toxicity.¹

The use of Abasaglar may be considered during pregnancy, if clinically needed .¹

It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia. 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.¹

Detailed information

Published data do not report a clear association with insulin glargine use during pregnancy and

• major birth defects

• miscarriage, or

• adverse maternal or fetal outcomes.^2,3

However, these data cannot definitely establish the absence of any risk because of methodological limitations of the studies that included

• small sample size, and

• some with no comparative group.^2,3

The safety of Abasaglar has not been systematically studied in

• pregnant patients with DM

• patients with GDM, or

• the postdelivery period.⁴

During the Abasaglar phase 3 studies, only 1 patient who received Abasaglar became pregnant. The pregnancy ended in a live birth without known birth defects.⁴

References

1. Abasaglar [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Pollex E, Moretti ME, Koren G, Feig DS. Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Ann Pharmacother. 2011;45(1):9-16. http://dx.doi.org/10.1345/aph.1P327

3. Lepercq J, Lin J, Hall GC, et al. Meta-analysis of maternal and neonatal outcomes associated with the use of insulin glargine versus NPH insulin during pregnancy. Obstet Gynecol Int. 2012;2012:649070. http://dx.doi.org/10.1155/2012/649070

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

DM = diabetes mellitus

GDM = gestational diabetes mellitus

Lantus = Lantus® (insulin glargine) 100 units/mL

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus