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): Immunogenicitet

Det föreligger en potential för immunogenicitet med glukagon näspulver på samma sätt som med alla terapeutiska peptider.

Detailed Information

As with all therapeutic peptides, there is the potential for immunogenicity with NG.1

Overall, 5.6 % of patients developed treatment-emergent anti-glucagon antibodies. These antibodies were not neutralising and did not lower the efficacy of glucagon nor were they associated with the development of treatment-emergent adverse reactions.2

Comparison of incidence of antibodies to NG with the incidences of antibodies to other products may be misleading due to the differences in the assays used.3

References

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

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

3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Assay development and validation for immunogenicity testing of therapeutic protein products: guidance for industry. https://www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf. Updated April 2016. Accessed July 24, 2019.

Glossary

NG = nasal glucagon (glucagon nasal powder)

Datum fӧr senaste ӧversyn 2019 M07 24


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