Use
During Pregnancy
A
large amount of data on pregnant women (more than 1000 pregnancy
outcomes) indicate no malformative nor feto/neonatal toxicity of
insulin lispro. URLi (LY900014) can be used during pregnancy if
clinically needed. 1
Published
studies with IL-100 used during pregnancy have not reported an
association between IL-100 and
induction
of major birth defects
miscarriage,
or
adverse
maternal or fetal outcomes.2-4
There
are no available data with Lyumjev in pregnant women to inform a
drug-associated risk for major birth defects and miscarriage.4
It
is essential to maintain good control of an insulin-treated
(insulin-dependent or gestational) diabetes patient throughout
pregnancy. Insulin requirements usually fall during the first
trimester and increase during the second and third trimesters. After
delivery, insulin requirements normally return rapidly to
pre-pregnancy values. Patients with diabetes should be advised to
inform their doctor if they are pregnant or are contemplating
pregnancy. Careful monitoring of glucose control is essential in
pregnant patients with diabetes.1
There
are risks to the mother and fetus associated with poorly controlled
DM in pregnancy.4-6
In
animal studies conducted by Lilly, treprostinil had no effect on
reproduction or fetal development.4
Treprostinil
is used as an excipient in the Lyumjev formulation. The dose of
treprostinil is 10 ng/unit of insulin lispro in the 100 units/mL
formulation. No detectable circulating concentrations or systemic
effects of treprostinil have been reported.4,7
Use
During Lactation
URLi
(LY900014) can be used during breast-feeding. Patients with diabetes
who are breast-feeding may require adjustments in insulin dose, diet
or both. 1
There
are no data for Lyumjev regarding its
presence
in human milk
effects
on the breastfed infant, or
effect
on milk production.4
A
single small study reported that exogenous insulin was present in
human milk.4,8
The
developmental and health benefits of breastfeeding should be
considered along with
the
mother’s clinical need for insulin
any
potential adverse effects on the breastfed child from Lyumjev, and
the
underlying maternal condition.4
Fertility
Insulin
lispro did not induce fertility impairment in animal studies. 1
References
1.
Lyumjev [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
2.
Bhattacharyya A, Brown S, Hughes S, Vice PA. Insulin lispro and
regular insulin in pregnancy. Q J Med. 2001;94(5):255-260.
http://dx.doi.org/10.1093/qjmed/94.5.255
3.
Mecacci F, Carignani L, Cioni R, et al. Maternal metabolic control
and perinatal outcome in women with gestational diabetes treated with
regular or lispro insulin: comparison with non-diabetic pregnant
women. Eur J Obstet Gynecol Reprod Biol. 2003;111(1):19-24.
http://dx.doi.org/10.1016/S0301-2115(03)00157-X
4.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5.
Platt MJ, Stanisstreet M, Casson IF, et al. St Vincent’s
Declaration 10 years on: outcomes of diabetic pregnancies. Diabet
Med. 2002;19(3):216-220.
http://dx.doi.org/10.1046/j.1464-5491.2002.00665.x
6.
Suhonen L, Hiilesmaa V, Teramo K. Glycaemic control during early
pregnancy and fetal malformations in women with type 1 diabetes
mellitus. Diabetologia. 2000;43(1):79-82.
http://dx.doi.org/10.1007/s001250050010
7.
Michael MD, Zhang C, Siesky AM, et al. Exploration of the mechanism
of accelerated absorption for a novel insulin lispro formulation
[abstract]. Diabetes. 2017;66(suppl 1):A250.
https://doi.org/10.2337/db17-890-1488
8.
Jovanovic-Peterson L, Fuhrmann K, Hedden K, et al. Maternal milk and
plasma glucose and insulin levels: studies in normal and diabetic
subjects. J Am Coll Nutr. 1989;8(2):125-131.
http://dx.doi.org/10.1080/07315724.1989.10720287
Glossary
DM =
diabetes mellitus
IL-100
= Humalog® (insulin lispro injection) 100 units/mL
Lilly
= Eli Lilly and Company
treprostinil
= Remodulin® (treprostinil) injection
URLi
= ultra rapid lispro
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.