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Lyumjev ® (insulin lispro - aabc) injection
100 units/mL, 200 units/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the long-term safety of treprostinil excipient contains in Lyumjev® (insulin lispro-aabc)?
In Lyumjev formulation, the microdoses of treprostinil used as an excipient induce only a local vasodilation effect. Treprostinil was not measurable in the blood circulation, and no systemic effects were seen.
Treprostinil - Long Term Safety
Remodulin® (treprostinil) injection has been approved to treat pulmonary arterial hypertension (PAH) for approximately 20 years and the safety profile is established.1
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® (insulin lispro-aabc).1,2
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.3-5
The commercial formulation of Lyumjev contains 10 ng of treprostinil per unit of insulin lispro in a 100 unit/mL formulation.2
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.3-5
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; 2021.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Leohr 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
4Leohr 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
5Pratt 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: May 04, 2023