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Lyumjev ® (insulin lispro)
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Can Lyumjev® (Insulin lispro) be used in pregnant and breastfeeding women?
Lyumjev has not been investigated in pregnant women or breastfeeding women. Lyumjev can be used during pregnancy if clinically needed.
Content overview
Use of Lyumjev during pregnancy
The active ingredient in Lyumjev is insulin lispro, the same as Humalog.1
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of insulin lispro.
Lyumjev can be used during pregnancy if clinically needed. 2
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.2
Use of Lyumjev when breastfeeding
Lyumjev can be used during breast-feeding. Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.2
It is not known if insulin lispro is excreted in significant amounts in human breast milk.1
There are no clinical data on Lyumjev regarding its
- presence in human milk
- effects on the breastfed infant, or
- effect on milk production.1
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.1
Impact of Lyumjev on fertility
Insulin lispro did not induce fertility impairment in animal studies. 2
Safety of treprostinil used as an active excipient in Lyumjev
In the formulation of Lyumjev, microdoses of treprostinil are used as an excipient to increase blood flow at the site of injection through localized vasodilation.6-8
The commercial formulation of Lyumjev contains 10 ng of treprostinil per unit of insulin lispro in a 100 unit/mL formulation.1
Treprostinil was not measurable in the blood circulation, and no systemic effects were seen with bolus doses of Lyumjev up to 50 units in phase 1b studies.6-8
Embryo-fetal development studies indicated that treprostinil was not teratogenic
- at doses up to 0.1 mg/kg/day in rats with a safety margin of 736-fold the maximum anticipated human exposure, or
- at doses up to 0.4 mg/kg/day in rabbits with a safety margin of 9,136-fold the maximum anticipated human exposure.1
In the prenatal and postnatal development study in rats, there was no evidence of maternal toxicity or adverse effects on offspring growth, behavior, and reproduction at doses up to 0.1 mg/kg/day with a safety margin of 462-fold the maximum anticipated human exposure.1
Impact of Lyumjev on fertility
Insulin lispro did not induce fertility impairment in animal studies. 2
Safety of treprostinil used as an active excipient in Lyumjev
In the formulation of Lyumjev, microdoses of treprostinil are used as an excipient to increase blood flow at the site of injection through localized vasodilation.6-8
The commercial formulation of Lyumjev contains 10 ng of treprostinil per unit of insulin lispro in a 100 unit/mL formulation.1
Treprostinil was not measurable in the blood circulation, and no systemic effects were seen with bolus doses of Lyumjev up to 50 units in phase 1b studies.6-8
Embryo-fetal development studies indicated that treprostinil was not teratogenic
- at doses up to 0.1 mg/kg/day in rats with a safety margin of 736-fold the maximum anticipated human exposure, or
- at doses up to 0.4 mg/kg/day in rabbits with a safety margin of 9,136-fold the maximum anticipated human exposure.1
In the prenatal and postnatal development study in rats, there was no evidence of maternal toxicity or adverse effects on offspring growth, behavior, and reproduction at doses up to 0.1 mg/kg/day with a safety margin of 462-fold the maximum anticipated human exposure.1
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Lyumjev [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
3Bhattacharyya 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
4Mecacci 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
5Jovanovic-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
6Leohr J, Pratt E, Heilmann C, et al. Treprostinil causes local vasodilation is well tolerated, and results in faster absorption of insulin lispro. Diabetologia. 2017;60(suppl 1):S313. European Association for the Study of Diabetes abstract 685. https://doi.org/10.1007/s00125-017-4350-z
7Leohr J, Pratt EJ, Heilmann C, et al. A novel insulin lispro formulation containing citrate and treprostinil demonstrates faster absorption and onset of insulin action in healthy subjects. Diabetes. 2017;66(suppl 1):A253. American Diabetes Association abstract 976‑P. https://doi.org/10.2337/db17-890-1488
8Pratt E, Leohr J, Heilmann C, et al. Treprostinil causes local vasodilation, is well tolerated, and results in faster absorption of insulin lispro. Diabetes. 2017;66(suppl 1):A253. American Diabetes Association abstract 975‑P. https://doi.org/10.2337/db17-890-1488
Date of Last Review: 03 May 2023