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Lyumjev ® ▼ (insulin lispro)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Lyumjev® ▼ (insulin lispro): Use in Pregnant and Breastfeeding Women
Lyumjev has not been investigated in pregnant women or in women who are breastfeeding.
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
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
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
Insulin lispro did not induce fertility impairment in animal studies. 1
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
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
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.
Date of Last Review: 24 January 2020