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Lyumjev ® ▼ (insulin lispro)
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Lyumjev Summary of Product Characteristics (SmPC)
Lyumjev® ▼ (insulin lispro): Citrate and Effect as Excipient
Citrate is an excipient in Lyumjev formulation that acts to increase vascular permeability.
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
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.
Date of Last Review: August 06, 2019
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