Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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

Baqsimi® (glukagon näspulver): Nysning

I den pivotala pediatriska studien nös en person efter administrering av glukagon näspulver. Dosen upprepades inte, och deltagaren uppfyllde effektparametrarna.

Detailed Information

In the pivotal, multicenter, randomized, crossover study comparing NG with IM glucagon in 48 pediatric participants with T1DM who were 4 to <17 years of age, one participant experienced sneezing after the 3 mg NG administration. The dose was not repeated after sneezing, and the participant met the per protocol efficacy outcome measure of a BG increase of greater than or equal to 1.4 mmol/L (25 mg/dL) from the BG glucose nadir within 20 minutes following glucagon administration.1

To better facilitate evaluation of the efficacy in pediatric patients, BG criteria similar to what was used in the adult pivotal study were applied retrospectively to the pediatric pivotal study.2

Efficacy was therefore, also assessed based on percentage of pediatric patients with a BG increase of greater than or equal to 1.1 mmol/L (20 mg/dL) from the BG nadir within 30 minutes following glucagon administration.3

References

1. Sherr JL, Ruedy KJ, Foster NC, et al; T1D Exchange Intranasal Glucagon Investigators. Glucagon nasal powder: a promising alternative to intramuscular glucagon in youth with type 1 diabetes. Diabetes Care. 2016;39(4):555-562. https://doi.org/10.2337/dc15-1606

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

3. Baqsimi [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

BG = blood glucose

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24

Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss