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

Kan Baqsimi® (Glukagon näspulver) orsaka huvudvärk?

Nasal glukagon orsakar vanligtvis huvudvärk som en biverkning, vilket överensstämmer med nasal administrering.

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en-GB

Experience from the nasal glucagon studies

Index

Adult Pivotal Study 1 and 2

These were randomized, multicenter, open-label, crossover studies that evaluated nasal glucagon (NG) 3 mg compared with intramuscular (IM) glucagon to treat insulin-induced hypoglycemia in adults with

  • type 1 diabetes mellitus (T1DM), in Study 11, and
  • T1DM or type 2 diabetes mellitus (T2DM), in Study 2.2
Headache Reported as an Adverse Reaction in Adults With T1DM and T2DM in Study 1 and Study 23

Adverse Reaction, n (%)

Study 1
T1DM

Study 2
T1DM and T2DM

NG 3 mg
(n=70)

NG 3 mg
(n=83)

All Headache

10 (14.3)

17 (20.5)

Severity

Mild

4 (40.0)

11 (64.7)

Moderate

6 (60.0)

4 (23.5)

Severe

0 (0.0)

2 (11.8)

Abbreviations: NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

Headache Resolution Time in Adults With T1DM and T2DM in Study 23

Resolution Time

NG 3 mg 
(n=83)
n (%)

<24 h

14 (82.4)

≥24 h

3 (17.6)

Abbreviations:NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

Headache Resolution Time in Adults With T1DM in Study 13

Resolution Time

NG 3 mg
(n=70)
n (%)

<1 h

2 (20.0) 

<2 h

4 (40.0)

<3 h

6 (60.0)

<4 h

7 (70.0)

<6 h

8 (80.0)

<24 h

10 (100.0)

Abbreviations: NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus.

Adult Integrated Safety Analysis

In the adult integrated safety analysis, which included 6 clinical studies, 86 NG-treated adults reported 114 headaches.3

One headache in the NG-treated group did not have documented resolution during the study.3

Of the headaches reported, approximately

  • 50% resolved in less than 4 hours
  • 92% resolved in less than 24 hours, and 
  • 8% resolved in more than 24 hours.3

Two headaches were severe, but none of the headaches was considered serious.3

Two adults discontinued NG due to adverse reactions. These adults had multiple adverse reactions or symptoms, including headache, and it was not clear which particular event led to discontinuation.3

Adult Real-World Study

A phase 3, open-label, multicenter, single-arm study evaluated the effectiveness and ease of use of NG 3 mg in the treatment of moderate or severe hypoglycemic events in adults with T1DM in a real-world setting.4

The main safety analysis population included 74 adults, who reported adverse reactions through the Hypoglycemia Episode Questionnaire.3

Of the 44 headaches reported

  • 15 (34%) had a duration of less than or equal to 1 hour
  • 24 (55%) had a duration of greater than 1 hour, and
  • 5 (11%) had missing information on duration.3

Pediatric Pivotal Study

A randomized, multicenter, dose finding clinical study evaluated the ability of NG 2 mg and 3 mg doses compared with IM glucagon to increase blood glucose (BG) after insulin-induced reduction in BG in children and adolescents (aged 4 to <17 years) with T1DM.5

The severity and the resolution time of the headache reported, can be found in Headache Reported as an Adverse Reaction in the Pediatric Pivotal Study and Headache Resolution Time in the Pediatric Pivotal Study.

Headache Reported as an Adverse Reaction in the Pediatric Pivotal Study3

Adverse Reaction, n (%)

NG 3 mg
(n=36)

All Headache

9 (25.0)

Severity

Mild

7 (77.8)

Moderate

2 (22.2)

Severe

0 (0.0)

Abbreviations: NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus.

Headache Resolution Time in the Pediatric Pivotal Study3

Resolution Time

NG 3 mg
(n=36)
n (%)

<24 h

8 (88.9)

≥24 h

1 (11.1)

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

In the review of both NG 2 mg and 3 mg doses in the pediatric pivotal study, 12 children or adolescents reported 13 headaches.3

One severe headache was reported but was not considered serious.3

One child discontinued NG due to adverse reactions. This child had multiple adverse reactions/symptoms, including headache, and it was not clear which particular event led to discontinuation.3

Pediatric Real-World Study

A phase 3, open-label, multicenter, single-arm study evaluated the effectiveness and ease of use of NG 3 mg in the treatment of moderate or severe hypoglycemic events in children and adolescents (aged 4 to <18 years) with T1DM in a real-world use setting.6

The main safety analysis population included 14 children or adolescents, who reported adverse reactions through the Hypoglycemia Episode Questionnaire.3

Of the 11 headaches reported

  • 2 (18%) had a duration of less than 1 hour
  • 5 (46%) had a duration of greater than 1 hour, and
  • 4 (36%) had missing information on duration.3

References

1Suico JG, Hövelmann U, Zhang S, et al. Glucagon administration by nasal and intramuscular routes in adults with type 1 diabetes during insulin-induced hypoglycaemia: a randomised, open-label, crossover study. Diabetes Ther. 2020;11(7):1591-1603. https://doi.org/10.1007/s13300-020-00845-7

2Rickels 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

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Seaquist ER, Dulude H, Zhang XM, et al. Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real-world setting. Diabetes Obes Metab. 2018;20(5):1316-1320. https://doi.org/10.1111/dom.13278

5Sherr 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

6Deeb LC, Dulude H, Guzman CB, et al. A phase 3 multicenter, open-label, prospective study designed to evaluate the effectiveness and ease of use of nasal glucagon in the treatment of moderate and severe hypoglycemia in children and adolescents with type 1 diabetes in the home or school setting. Pediatr Diabetes. 2018;19(5):1007-1013. https://doi.org/10.1111/pedi.12668

Datum fӧr senaste ӧversyn 2019 M07 24


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