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