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): Användning hos barn

Säkerhet och effekt av Lyumjev hos barn och ungdomar under 18 år har ännu inte fastställts. Inga data finns tillgängliga. Fas 1 och 3-studier med Lyumjev i pediatriska populationer pågår.

Detailed Information

The safety and efficacy of Lyumjev in children and adolescents below 18 years of age have not yet been established. No data are available. 1

A total of 2 URLi (LY900014) studies involving pediatric patients have been initiated and include

  • a phase 1 clinical study (ITSA) evaluating the PK/GD of URLi (LY900014) compared with IL-100 in children, adolescents, and adults with T1DM, and

  • a phase 3 clinical study (ITSB) comparing URLi (LY900014) with IL-100 in children and adolescents with T1DM that has begun on March 8, 2019 and should be completed in second quarter 2021.2,3

References

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

2. A study of LY900014 in participants with type 1 diabetes mellitus. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03465878. Updated December 4, 2019. Accessed April 20, 2020.

3. A study comparing LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (PRONTO-Peds). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03740919. Updated March 17, 2020. Accessed April 20, 2020.

Glossary

GD = glucodynamic

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

Lilly = Eli Lilly and Company

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus

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 M02 28


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