Lyumjev ® ▼ (insulin lispro)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Lyumjev Summary of Product Characteristics (SmPC)

Lyumjev® ▼ (insulin lispro): Treprostinil Long-term Safety

In Lyumjev formulation, the microdoses of treprostinil used as an excipient induce only a local vasodilation effect.

Treprostinil - Long Term Safety

Treprostinil was not measurable in the circulation, and no systemic effects were seen with bolus doses of Lyumjev up to 50 units in phase 1b studies.1-4

Treprostinil has been approved to treat PAH for approximately 15 years and the safety profile is established.5

In the treatment of PAH, treprostinil is used at initial doses of 1.25 ng/kg/min as a continuous infusion and achieves an average steady state concentration that is at least 200-fold higher than the levels in patients treated with Lyumjev.4,5

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.1-3

The commercial formulation of Lyumjev contains 10 ng of treprostinil per unit of insulin lispro in a 100-unit/mL formulation.4

References

1. Leohr J, Pratt E, Heilmann C, et al. Treprostinil causes local vasodilation is well tolerated, and results in faster absorption of insulin lispro [abstract]. Diabetologia. 2017;60(suppl 1):S313. http://dx.doi.org/10.1007/s00125-017-4350-z

2. Leohr 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 [abstract]. Diabetes. 2017;66(suppl 1):A253. http://dx.doi.org/10.2337/db17-890-1488

3. Pratt E, Leohr J, Heilmann C, et al. Treprostinil causes local vasodilation, is well tolerated, and results in faster absorption of insulin lispro [abstract]. Diabetes. 2017;66(suppl 1):A253. http://dx.doi.org/10.2337/db17-890-1488

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; 2018.

Glossary

PAH = pulmonary arterial hypertension

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: July 19, 2019

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