Abasaglar Safe in Pregnancy ?
safety of Abasaglar has not been systematically studied in
patients with diabetes mellitus
with gestational diabetes mellitus, or
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
data do not report a clear association with insulin glargine use
during pregnancy and
maternal or fetal outcomes.3,4
these data cannot definitely establish the absence of any risk
because of methodological limitations of the studies that included
sample size, and
with no comparative group.3,4
are the Criteria Used in Clinical Trials Related to Pregnant Women ?
clinical data on exposed pregnancies from controlled clinical studies
are available for insulin glargine.2
the Abasaglar phase 3 studies, patients who became pregnant were
from the study, and
for safety follow-up.1
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
are the Results of Insulin Glargine in Animal Reproductive Studies ?
data with another insulin glargine product do not indicate
from the label
use of Abasaglar may be considered during pregnancy, if clinically
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
decrease during the first trimester,
generally increase during the second and third trimesters, and
rapidly Immediately after delivery (increased risk of
monitoring of glucose control is essential.2
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Abasaglar [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Pollex E, Moretti ME, Koren G, Feig DS. Safety of insulin glargine
use in pregnancy: a systematic review and meta-analysis. Ann
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.