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Lyumjev ® (insulin lispro)
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What is the difference between Lyumjev® (insulin lispro) and Humalog?
While Lyumjev and Humalog contain insulin lispro as the active substance, Lyumjev also contains excipients that accelerate the absorption of insulin lispro, with earlier onset and shorter duration of insulin exposure.
Which excipients accelerate the absorption of Lyumjev?
The formulation of Lyumjev contains sodium citrate dihydrate (citrate) and treprostinil sodium (treprostinil) that act to accelerate the absorption of insulin lispro.1-4
Citrate increases local vascular permeability and treprostinil induces local vasodilation to achieve accelerated absorption of insulin lispro.4
What are the pharmacodynamic differences between Lyumjev and Humalog?
Lyumjev is a novel insulin lispro formulation that, compared with the Humalog formulation, demonstrates
A glucose clamp study was conducted in 40 type 1 diabetes patients given Lyumjev and Humalog subcutaneously as a single 15 unit dose. Results are provided in Mean glucose infusion rate (GIR) in patients with type 1 diabetes after subcutaneous injection of Lyumjev or Humalog (15 unit dose).4
Lyumjev has been shown to be equipotent to Humalog on a unit for unit basis but its effect is more rapid with a shorter duration of action
- Onset of action of Lyumjev was 20 minutes post dose, 11 minutes faster than Humalog
- During the first 30 minutes post dose, Lyumjev had a 3‑fold greater glucose lowering effect compared to Humalog
- Maximum glucose‑lowering effect of Lyumjev occurred between 1 and 3 hours after injection
- The late insulin action, from 4 hours until the end of the glucose clamp, was 54 % lower with Lyumjev than observed with Humalog
- The duration of action of Lyumjev was 5 hours, 44 minutes shorter than Humalog
- The total glucose infused during the clamp was comparable between Lyumjev and Humalog.4
Similarly, a faster early insulin action and a reduced late insulin action was observed with Lyumjev in type 2 diabetes patients.4
Additional information on the formulations of Lyumjev and Humalog
The formulations of Lyumjev and Humalog 100 and 200 units/mL share similarities such as the glycerin, the metacresol, and the zinc oxide.4,6,7
Comparison of Formulations of the 100 Units/mL and 200 Units/mL Concentrations of Lyumjev and Humalog compares the excipients of Lyumjev and Humalog 100 and 200 units/mL and shows the similarities and differences.5
Ingredienta |
100 Units/mL |
200 Units/mL |
100 Units/mL |
200 Units/mL |
Purpose |
Lyumjev |
Humalog |
||||
Insulin lispro, units/mL (mg/mL) |
100 (3.5) |
200 (6.9) |
100 (3.5) |
200 (6.9) |
NA |
Sodium citrate dihydrate |
4.4 |
4.4 |
NA |
NA |
Increasing the local vascular permeability |
Treprostinil sodium, mcg/mL |
1.0 |
1.0 |
NA |
NA |
Enhancing local vasodilation |
Glycerol/Glycerin |
12.1 |
12.1 |
16.0 |
16.0 |
Tonicity modifier |
Metacresol |
3.15 |
3.15 |
3.15 |
3.15 |
Preservative and insulin stabilizer |
Magnesium chloride hexahydrate |
1.0 |
1.0 |
NA |
NA |
Source of magnesium ions |
Zinc oxideb |
0.039c |
0.052d |
0.0197 |
0.046 |
Insulin stabilizer |
Dibasic sodium phosphate |
NA |
NA |
1.88 |
NA |
Buffering agent |
Tromethamine |
NA |
NA |
NA |
5.0 |
|
Phenol |
NA |
NA |
Trace |
Trace |
Preservative and insulin stabilizer |
Hydrochloric acid solution 10% |
q.s. to adjust pH to 7.0-7.8 |
pH adjustment |
|||
Sodium hydroxide solution 10% |
q.s. to adjust pH to 7.0-7.8 |
pH adjustment |
|||
Water for injection |
q.s. to labeled fill amount |
Vehicle to deliver the ingredients |
|||
Abbreviations: Humalog = Humalog® (insulin lispro); Lyumjev = Lyumjev® (insulin lispro); q.s. = quantum sufficit; NA = not applicable;
aData presented in mg/mL unless otherwise indicated.
bTo provide zinc ion.
cAmount is variable in order to attain 0.039 mg zinc ion per mL.
dAmount is variable in order to attain 0.052 mg zinc ion per mL.
References
1Michael MD, Zhang C, Siesky AM, et al. Exploration of the mechanism of accelerated absorption for a novel insulin lispro formulation. Diabetes. 2017;66(suppl 1):A250. American Diabetes Association abstract 968‑P. https://doi.org/10.2337/db17-890-1488
2Paavola CD, Sperry AE, Hansen RJ, et al. A stable, hexameric, ultra rapid insulin formulation containing citrate. Diabetes. 2017;66(suppl 1):A254. American Diabetes Association abstract 979‑P. https://doi.org/10.2337/db17-890-1488
3Pratt 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
4Lyumjev [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6Humalog [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
7Humalog 200 units/ml KwikPen [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
Date of Last Review: 08 November 2022