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): Användning vid lungsjukdomar

Glukagon näspulver är utformat för att absorberas i näshålan och förväntas vara säkert och effektivt för patienter med olika lungsjukdomar.

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.1-3

Five participants in the adult pivotal study of NG reported the medical condition of asthma at baseline. One participant withdrew from the study before completing both dosing visits, and the other 4 participants completed the study.4

Five participants in the pediatric pivotal study of NG reported the medical condition of asthma at baseline, and they all completed the study.4

NG has not been studied in people with diabetes and lung conditions such as 

  • chronic obstructive pulmonary disease

  • emphysema

  • chronic bronchitis

  • cystic fibrosis

  • bronchietasis

  • pneumonia

  • pleural effusion

  • interstitial lung disease

  • lung cancer

  • pulmonary hypertension

  • pulmonary fibrosis 

  • sarcoidosis, or

  • requiring oxygen.

NG is designed to be absorbed in the nasal cavity and expected to have comparable efficacy and safety profile in people with these lung conditions.

Preclinical Animal Studies

During preclinical toxicology studies that assessed the safety of glucagon nasal powder in animals, a pulmonary insufflation study was conducted. Rats were administered a single dose of 0.5 mg glucagon nasal powder (0.05 mg glucagon) by intra-tracheal administration. No adverse findings were found related to the direct deposition of the glucagon nasal powder into the lungs of these rats.5

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

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

5. Reno FE, Normand P, McInally K, et al. A novel nasal powder formulation of glucagon: toxicology studies in animal models. BMC Pharmacol Toxicol. 2015;16(1):29. https://doi.org/10.1186/s40360-015-0026-9

Glossary

NG = nasal glucagon (glucagon nasal powder)

Datum fӧr senaste ӧversyn 2019 M08 23


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