Lyumjev® ▼ (insulin lispro): Citrate and Effect as Excipient

Lyumjev - Citrate in Formulation

Sodium citrate is an excipient that acts to increase vascular permeability, resulting in the accelerated absorption of insulin lispro.^1-4

Citrate is a common GRAS ingredient used in many pharmaceutical formulations.^5-7

References

1. 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. American Diabetes Association abstract 976‑P. http://dx.doi.org/10.2337/db17-890-1488

2. Michael MD, Zhang C, Siesky AM, et al. Exploration of the Mechanism of Accelerated Absorption for a Novel Insulin Lispro Formulation [abstract]. Diabetes. 2017;66(suppl 1):A250. http://dx.doi.org/10.2337/db17-890-1488

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

4. Lyumjev [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

5. US Food and Drug Administration (FDA). Generally Recognized as Safe (GRAS). Updated September 6, 2019. Accessed July 3, 2020. https://www.fda.gov/food/ingredientspackaginglabeling/gras/

6. US Food and Drug Administration (FDA). Select Committee on GRAS Substances (SCOGS) Opinion: Citric acid, Citrates. Updated September 24, 2015. Accessed July 3, 2020. http://wayback.archive-it.org/7993/20171031063409/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm260861.htm

7. US Food and Drug Administration (FDA). CFR - Code of Federal Regulations Title 21. US Food and Drug Administration. Updated April 1, 2019. Accessed July 3, 2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1751

Glossary

GRAS = generally recognized as safe

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.