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Abasaglar ® (basal insulin glargine)
Is Abasaglar® (insulin glargine) safe to use during pregnancy?
Basal insulin glargine was not systematically studied in pregnancy during clinical trials.
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
However, these data cannot definitely establish the absence of any risk because of methodological limitations of the studies that included
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
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