Abasaglar ® (basal insulin glargine)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Abasaglar Summary of Product Characteristics (SmPC)

Is Abasaglar® (insulin glargine) safe to use during pregnancy?

Basal insulin glargine was not systematically studied in pregnancy during clinical trials.

Is Abasaglar Safe in Pregnancy ?

The safety of Abasaglar has not been systematically studied in

  • pregnant patients with diabetes mellitus

  • patients with gestational diabetes mellitus, or

  • the postdelivery period.1

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.2

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.3,4

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.3,4

What are the Criteria Used in Clinical Trials Related to Pregnant Women ?

No clinical data on exposed pregnancies from controlled clinical studies are available for insulin glargine.2

During the Abasaglar phase 3 studies, patients who became pregnant were

  • discontinued from the study, and

  • monitored for safety follow-up.1

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.1

What are the Results of Insulin Glargine in Animal Reproductive Studies ?

Animal data with another insulin glargine product do not indicate reproductive toxicity.2

Information from the label

The use of Abasaglar may be considered during pregnancy, if clinically needed.2

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.2

Insulin requirements :

  • may decrease during the first trimester,

  • may generally increase during the second and third trimesters, and

  • decline rapidly Immediately after delivery (increased risk of hypoglycaemia).2

Careful monitoring of glucose control is essential.2

References

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

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

3. 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

4. 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

Date of Last Review: April 06, 2021


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