Lyumjev® ▼ (insulin lispro): Use in Pregnant and Breastfeeding Women

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.