Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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Baqsimi® (glukagon näspulver): Nästäppa och sekretion

Nästäppa och/eller sekretion, med eller utan samtidig användning av näsdroppar, hade ingen signifikant effekt på glukagon näspulvrets FK och FD i en klinisk studie som utfördes på vuxna deltagare.

Detailed Information

Common cold with nasal congestion or the use of a nasal decongestant did not impact the PK of NG.1

Common cold with nasal congestion tested with or without the use of a nasal decongestant did not impact the PD of NG.1

A clinical study evaluated nasal congestion and/or discharge from a common cold (with or without nasal decongestant use) in adult participants aged 18 to 50 years old.2 There have been no studies conducted in pediatric participants or participants older than 50 years with nasal congestion and/or discharge from a common cold (with or without nasal decongestant use). 

Clinical Study

A single center, open-label study in 36 otherwise healthy, adult participants aged 18 to 50 years old with nasal congestion and/or discharge from a common cold (with or without nasal decongestant use) evaluated the PK, PD, and safety of NG (Table 1).2

Table 1. Study Design of the Effect of Symptoms from the Common Cold on the Pharmacokinetics, Pharmacodynamics, and Safety of NG2

Treatment

Group 1
(n=18)

Group 2
(n=18)

Treatment for cold symptoms

No

Nasal decongestant oxymetazolinea

Treatment 1b (3-mg NG)

Yes

Yes

Treatment 2c (3-mg NG)

Yes

No

Abbreviation: NG = nasal glucagon (glucagon nasal powder).

a Oxymetazoline given 2 hours prior to 3-mg NG treatment.

b All participants had a common cold with nasal congestion and/or nasal discharge.

c Participants were symptom-free ≥2 days before Treatment 2.

Pharmacokinetics and Pharmacodynamics Results

There were no clinically relevant differences in the glucagon PK and PD profiles after NG treatment in adult participants with a common cold (with or without nasal decongestant use) and adult participants with no cold symptoms.2

Glucose and glucagon levels increased rapidly to peak glucose levels at 30 to 40 minutes postdose and to peak glucagon levels at 20 minutes postdose for all adult participants and were not significantly affected by nasal congestion and/or nasal discharge (with or without nasal decongestant use).2

Safety

The most common adverse reactions reported in the study were transient and included

  • lacrimation

  • nasal discomfort

  • rhinorrhea, and

  • nausea.2

Transient adverse reactions were more frequent in adult participants with a common cold than adult participants with no cold symptoms.2

References

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

2. Guzman CB, Dulude H, Piche C, et al. Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: A randomized clinical trial. Diabetes Obes Metab. 2018;20(3):646-653. https://doi.org/10.1111/dom.13134

Glossary

NG = nasal glucagon (glucagon nasal powder)

PD = pharmacodynamic

PK = pharmacokinetic

Datum fӧr senaste ӧversyn 2019 M08 27

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