Lyumjev ® ▼ (insulin lispro)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

What is the amount of citrate used as excipient in Lyumjev®▼ (insulin lispro)?

The Lyumjev 100 units/mL formulation contains 44 mcg of citrate per unit of insulin lispro and the Lyumjev 200 units/mL formulation contains 22 mcg of citrate per unit of insulin lispro.

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UK_cFAQ_URI032_CITRATE_IN_FORMULATION
en-GB

Lyumjev - Citrate dose in commercial formulations

Sodium citrate dihydrate is an excipient that acts to increase vascular permeability, resulting in the accelerated absorption of insulin lispro.1-3

Citrate is a common generally recognized as safe (GRAS) ingredient used in many pharmaceutical formulations.4-6

The amount of sodium citrate dihydrate in the Lyumjev 200 units/mL commercial formulation is lower per unit of insulin lispro injected compared with the Lyumjev 100 units/mL commercial formulation (Amount of Sodium Citrate Dihydrate in the Lyumjev 200 Units/mL and Lyumjev 100 Units/mL Commercial Formulations).3

Amount of Sodium Citrate Dihydrate in the Lyumjev 200 Units/mL and Lyumjev 100 Units/mL Commercial Formulations3

Ingredients

Lyumjev 200 Units/mL

Lyumjev 100 Units/mL

Insulin lispro, units/mL

200

100

Sodium citrate dihydrate, mg/mL

4.4

4.4

Amount of sodium citrate dihydrate per unit of insulin lispro injected, mcg

22

44

Abbreviations: Lyumjev = Lyumjev® (insulin lispro).

References

1Leohr 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

2Michael 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

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

4US 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/

5Select committee on GRAS substances (SCOGS) opinion: citric acid, citrates. US Food and Drug Administration. 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

6US 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

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: 26 June 2020


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