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

Vilken är Baqsimi® (Glucagon näspulver) pediatriska dos?

Det har fastställts att en enkeldos med 3 mg glukagon näspulver var lämplig för användning i hela åldersspannet 4 till <17 år.

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Label Information

Nasal glucagon (NG) is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.1

Rationale behind the dosing

A randomized, multicenter, dose-finding clinical study compared NG 2-mg and 3-mg doses with intramuscular (IM) glucagon in children and adolescents (aged 4 to <17 years) with type 1 diabetes mellitus.2

A reduction in the blood glucose (BG) was insulin-induced. The primary efficacy outcome was defined as a ≥25 mg/dL rise in plasma glucose from nadir within 20 min of receiving glucagon without receipt of additional actions.2

NG 2 mg and 3 mg showed

  • similar plasma glucose responses, and
  • similar frequency of adverse reactions, which were transient.2

It was determined that a single 3 mg NG dose was appropriate for use across the entire 4 to <17 year age range.2

Study design

The participants were assigned to three age-groups:

  •  4- to <8
  •  8- to <12, and
  • 12 to <17.2

The participants of the first two cohorts were randomly assigned to one of two groups in a 2:1 ratio:

  • one group received NG 2 mg in one visit and 3 mg in the other visit in a double-blind, random order, and
  • the other group received a single weight-based dose of IM glucagon.2

Participants 12 to <17 years of age were randomly assigned in a 1:1 ratio to receive either 3 mg NG or 1 mg IM glucagon.2

References

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

2Sherr 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

Datum fӧr senaste ӧversyn 2019 M10 03


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