Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Lyumjev® ▼ (insulin lispro): Lokaltolerans av citrat

Inga patienter i Lyumjev fas 3 PRONTO-studierna avbröt behandlingen på grund av smärta vid injektionsstället. Rollen av citrat vid smärta vid injektionsstället är okänd.

Citrate Excipient and Injection Site Pain

In the phase 3 efficacy and safety studies, the incidence of injection site pain was significantly higher in patients treated with URLi (LY900014) compared with those treated with IL-100 (1.2% vs 0.0%, p=.002). Overall, injection site pain was reported in

  • 8 patients (0.7%, p=.06) in the PRONTO-T1D study, and 

  • 5 patients (0.7%, p=.031) in the PRONTO-T2D study.1-3

In the PRONTO-Pump study, the incidence of infusion site pain was similar between treatment groups with >90% of the events reported as mild. Infusion site pain was reported in

  • 9 patients (18.4%) in the URLi (LY900014) treatment group, and

  • 2 patients (4.2%) in the IL-100 treatment group.4,5

In the PRONTO studies, no patients discontinued treatment due to injection site pain.1,3,5

The role of citrate in injection site pain is unknown.6

References

1. Blevins T, Zhang Q, Frias JP, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in patients with type 2 diabetes (T2D): PRONTO-T2D [abstract 145-OR]. Diabetes. 2019;68(suppl 1). http://dx.doi.org/10.2337/db19-145-OR

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

3. Klaff LJ, Cao D, Dellva MA, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in T1D: PRONTO-T1D study [abstract 144-OR]. Diabetes. 2019;68(suppl 1). http://dx.doi.org/10.2337/db19-144-OR

4. A study of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes (PRONTO-Pump). ClinicalTrials.gov website. https://clinicaltrials.gov/show/NCT03433677. Updated October 8, 2019. Accessed April 20, 2020.

5. Bode BW, Liu R, Hardy TA, Ignaut DA. Compatibility and safety of ultra rapid lispro (URLi) with continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes: PRONTO-pump study [abstract 790]. Diabetologia. 2019;62(suppl 1):S383. http://dx.doi.org/10.1007/s00125-019-4946-6

6. Laursen T, Hansen B, Fisker S. Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol. 2006;98(2):218-221. http://dx.doi.org/10.1111/j.1742-7843.2006.pto_271.x

Glossary

AE = adverse event

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes

PRONTO-T1D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro with an open-label postprandial LY900014 Treatment group, in cOmbination with insulin glargine or insulin degludec, in adults with Type 1 Diabetes

PRONTO-T2D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro, boTh in cOmbination with insulin glargine or insulin degludec in adults with Type 2 Diabetes

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.

Datum fӧr senaste ӧversyn 2019 M10 25


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