Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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Baqsimi® (glukagon näspulver): Användning med andra nässprayer

Andra samtidiga nässprayer användes av deltagare under en av de pivotala vuxenstudierna och de pivotala pediatriska studierna på glukagon näspulver.

Detailed Information

Adult Participants

In one of the adult pivotal studies (Study 2), of NG, concomitant nasal sprays that were being used by participants at the time of study entry or initiated after glucagon treatment began included fluticasone and mometasone. Three participants were taking fluticasone, and one participant was taking mometasone. None of these participants discontinued from the study.1

In Study 2, NG demonstrated non-inferiority to IM glucagon in reversing insulin-induced hypoglycemia with 98.8% of NG-treated patients and 100% of IM glucagon-treated patients achieving treatment success within 30 minutes.1

Pediatric Participants

In the pediatric pivotal study of NG, concomitant nasal sprays that were being used by participants at the time of study entry or initiated after glucagon treatment began included desmopressin, fluticasone, and saline nasal mist. Two participants were taking fluticasone, and one of these discontinued the study. The other participant taking fluticasone, one participant taking desmopressin, and one participant using saline nasal mist all completed the study.1

The efficacy outcome measure was achieved in all 36 (100%) participants who received NG 3 mg and all 24 (100%) participants who received IM glucagon 1 mg.2

References

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

2. 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

Glossary

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

Datum fӧr senaste ӧversyn 2019 M09 04


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