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.

LYUMJEV™ (insulin lispro-aabc): Treprostinil Long-term Safety

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

Treprostinil has been approved to treat PAH for approximately 15 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.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

LYUMJEV™ (insulin lispro-aabc) injection, for subcutaneous or intravenous use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

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

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

3. Leohr 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

4. 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. Diabetes. 2017;66(suppl 1):A253. American Diabetes Association abstract 976‑P. https://doi.org/10.2337/db17-890-1488

5. Pratt 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

Glossary

Lyumjev = Lyumjev™ (insulin lispro-aabc)

PAH = pulmonary arterial hypertension

treprostinil = Remodulin® (treprostinil) injection

Date of Last Review: June 26, 2020


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