Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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Baqsimi® (glukagon näspulver): Användning med respiratoriska läkemedel som administreras via munnen

Det fanns vissa deltagare i de pivotala studierna av glukagon näspulver som tog samtidiga orala läkemedel för respiratoriska sjukdomar.

Detailed Information

The NG powder is absorbed passively through the nasal mucosa, and delivery does not require the person to be conscious or to inhale.1,2

Adult Pivotal Studies

Study 1

Participants in one of the adult pivotal studies, Study 1, reported respiratory medical conditions, including cough in 1 participant and oropharyngeal pain in 2 participants. These participants completed the study.3

Concomitant medications for respiratory conditions administered by mouth included codeine and throat lozenges.3

Study 2

Participants in one of the adult pivotal studies, Study 2, reported respiratory medical conditions, including asthma in 5 participants and seasonal allergy in 7 participants.3

Concomitant medications for respiratory conditions administered by mouth included

  • acetaminophen, phenylephrine, and guaifenesin

  • albuterol inhaler

  • cetirizine

  • fexofenadine

  • fluticasone oral inhaler

  • guaifenesin

  • loratadine, and

  • montelukast.3

One participant with asthma discontinued from the study prior to completing both dosing visits.3

Pediatric Pivotal Study

Participants who were enrolled in and completed the pediatric pivotal study reported respiratory medical conditions including

  • asthma, n=5

  • house dust allergy, n=1, and 

  • seasonal allergy, n=5.3

Concomitant medications for respiratory conditions administered by mouth included

  • albuterol inhaler

  • budesonide inhaler

  • cetirizine

  • fexofenadine

  • loratadine, and 

  • montelukast.3

References

1. Rickels MR, Ruedy KJ, Foster NC, et al; T1D Exchange Intranasal Glucagon Investigators. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270. https://doi.org/10.2337/dc15-1498

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

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

Glossary

NG = nasal glucagon (glucagon nasal powder)

Datum fӧr senaste ӧversyn 2019 M09 11

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