Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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Baqsimi® (glukagon näspulver): Farmakokinetik

Maximala plasmanivåer av glukagon för nasalt bruk uppnåddes i genomsnitt vid 15 minuter hos vuxna och vid 15–20 minuter hos barn och ungdomar efter administrering av glukagon näspulver.

Detailed Information

Absorption

Glucagon absorption via the nasal route achieved mean peak plasma levels of 6130 pg/mL at 15 minutes.1

Bioavailability

In an insulin-induced hypoglycemia study in adults with T1DM, the mean total plasma glucagon exposure after 3 mg NG was approximately 80% of that observed with 1 mg IM glucagon. This suggests that the relative bioavailability of NG is about 25% to 30% of IM glucagon.2 

Distribution

The apparent volume of distribution of glucagon was approximately 885 L via the nasal route.1

Metabolism

Glucagon is known to be degraded in the liver, kidneys, and plasma.1

Elimination

The mean half-life of glucagon was approximately 38 minutes via the nasal route.1

Pediatrics

In paediatric patients (4 to < 17 years), glucagon absorption via the nasal route, achieved mean peak plasma levels between 15 and 20 minutes.1

The median half-life was 21 to 31 minutes via the intranasal route.2

Special Populations

No formal studies have been performed to evaluate renal or hepatic impairment.1

Common cold with nasal congestion with or without concomitant use of a decongestant did not impact pharmacokinetics via the nasal route.1

References

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

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

Glossary

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24


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