Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Huvudvärk

Huvudvärk är en ofta rapporterad biverkning av administrering av glukagon för nasalt bruk och överensstämmer med administreringsvägen via näsan.

Detailed Information

Commonly reported adverse reactions following NG treatment, in both adult and pediatric populations, include local tolerability effects that are consistent with the nasal route of administration and include headache.1 

The time of onset and resolution of adverse reactions was captured differently across the NG studies.1

One of the pivotal studies, Study 1, of NG in adults collected the onset and resolution of adverse reactions with date and time, thus enabling more precise estimates of event duration in minutes or hours.1

Another pivotal study, Study 2, of NG in adults collected the onset date and resolution date of spontaneously reported adverse reactions without time (ie, no hour and minute). Thus, if an adverse reaction started and ended on the same day, the event duration was recorded as less than 24 hours. Resolution of events lasting longer were recorded in 1 day increments greater than 24 hours.1

All of the other studies of NG included in the adult integrated safety analysis collected the onset and resolution of adverse reactions with date and time, thus enabling more precise estimates of event duration in minutes or hours.1

The pivotal study of NG in children and adolescents collected the adverse reaction onset date and resolution date without time (ie, no hour and minute). Thus, if an adverse reaction started and ended on the same day, the event duration was recorded as less than 24 hours. Resolution of events lasting longer were recorded in 1 day increments greater than 24 hours.1 

Headaches in Adults

Adult Pivotal Studies

Study 1 was a randomized, multicenter, open-label, crossover study that evaluated NG 3 mg compared with injectable glucagon administered IM as treatment for insulin-induced hypoglycemia in adults with T1DM.2

Study 1 used the final NG drug product manufactured at commercial scale.2

Study 2 was a randomized, multicenter, open-label, crossover study that evaluated NG 3 mg compared with injectable glucagon 1 mg administered IM as treatment for insulin-induced hypoglycemia in adults with T1DM or T2DM.3

Headache occurred more frequently with NG but most were transient, resolving on the same day as onset (Table 1).2,3

Table 1. Headache Reported as an Adverse Reaction in Adults With T1DM and T2DM in Study 1 and Study 21

Adverse Reaction, n (%)

Study 1
T1DM

Study 1
T1DM

Study 2
T1DM and T2DM

Study 2
T1DM and T2DM

NG 3 mg
(n=70)

IM Glucagon 1 mg 
(n=69)

NG 3 mg
(n=83)

IM Glucagon 1 mg
(n=82)

All Headache

10 (14.3)

7 (10.1)

17 (20.5)

7 (8.5)

Severity

Mild

4 (40.0)

6 (85.7)

11 (64.7)

5 (71.4)

Moderate

6 (60.0)

1 (14.3)

4 (23.5)

2 (28.6)

Severe

0 (0.0)

0 (0.0)

2 (11.8)

0 (0.0)

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

The majority of headaches in the adults with T1DM in Study 1 resolved in less than 3 hours in the NG- and in less than 4 hours in the IM glucagon-treated groups (Table 2).1

Table 2. Headache Resolution Time in Adults With T1DM in Study 11

Resolution Time

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

IM Glucagon 1 mg
(n=69)
n (%)

<1 h

2 (20.0) 

0 (0.0)

<2 h

4 (40.0)

0 (0.0)

<3 h

6 (60.0)

3 (42.9)

<4 h

7 (70.0)

5 (71.4)

<6 h

8 (80.0)

7 (100.0)

<24 h

10 (100.0)

7 (100.0)

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

All headaches were mild or moderate in severity in Study 1 and none were considered serious.1

The majority of headaches in the adults with T1DM and T2DM in Study 2 resolved in less than 24 hours in both the NG- and IM glucagon-treated groups (Table 3).1

Table 3. Headache Resolution Time in Adults With T1DM and T2DM in Study 21

Resolution Time

NG 3 mg 
(n=83)
n (%)

IM Glucagon 1 mg  
(n=82)
n (%)

<24 h

14 (82.4)

4 (57.1)

24 h

3 (17.6)

3 (42.9)

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

Two of the headaches in the NG-treated group in Study 2 were severe.1

Adult Integrated Safety Analysis

A review of headache reported as an adverse reaction was conducted using the adult integrated safety population, which included 6 clinical studies.1

In the adult integrated safety analysis

  • 86 (36.8%) NG-treated adults reported 114 headaches, and

  • 14 (9.9%) IM glucagon-treated adults reported 16 headaches.1

Three headaches, which included 1 headache in the NG-treated group and 2 in the IM glucagon-treated group, did not have documented resolution during the study.1

In the studies that recorded time in addition to date, approximately

  • 50% of headaches resolved in less than 4 hours

  • 92% of headaches resolved in less than 24 hours, and 

  • 8% of headaches took greater than 24 hours to resolve.1

Two of the headaches in the NG-treated group were severe, but none of the headaches were considered serious.1

Two adults discontinued NG based on adverse reactions. These adults had multiple adverse reactions or symptoms, including headache, and it was not clear which particular event led to discontinuation.1

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 (home or work).4

In the adult real-world study, the main safety analysis population included 74 adults, and adverse reactions were solicited using the Hypoglycemia Episode Questionnaire.1

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.1

Headache in Children and Adolescents

Pediatric Pivotal Study

A randomized, multicenter, dose finding clinical study evaluated the ability of NG 2 mg and 3 mg doses compared with injectable glucagon 0.5 mg or 1.0 mg (based on body weight) administered IM to increase the BG after insulin-induced reduction in BG in children and adolescents (aged 4 to <17 years) with T1DM.5

Headache occurred more frequently with NG but most were transient, resolving on the same day as onset (Table 4).1

Table 4. Headache Reported as an Adverse Reaction in the Pediatric Pivotal Study1

Adverse Reaction, n (%)

NG 3 mg
(n=36)

IM Glucagona
(n=24)

All Headache

9 (25.0)

3 (12.5)

Severity

Mild

7 (77.8)

2 (66.7)

Moderate

2 (22.2)

1 (33.3)

Severe

0 (0.0)

0 (0.0)

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

a 0.5 mg or 1 mg IM glucagon (based on body weight).

Headache reported as an adverse reaction was reviewed in both NG 2 mg and 3 mg doses evaluated in the pediatric pivotal study.1

In the review of both NG 2 mg and 3 mg doses in the pediatric pivotal study

  • 12 (33.3%) NG-treated children or adolescents reported 13 headaches, and

  • 3 (12.5%) IM-treated children or adolescents reported 3 headaches.1

The majority of headaches in the pediatric pivotal study resolved in less than 24 hours in both the NG- and IM glucagon-treated groups (Table 5).1

Table 5. Headache Resolution Time in the Pediatric Pivotal Study1

Resolution Time

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

IM Glucagona
(n=24)
n (%)

<24 h

8 (88.9)

2 (66.7)

24 h

1 (11.1)

1 (33.3)

Abbreviations: IM = intramuscular; NG = nasal glucagon (glucagon nasal powder).

a 0.5 mg or 1 mg IM glucagon (based on body weight).

One severe headache was reported in the NG-treated group but was not considered serious.1

One child discontinued NG based on adverse reactions. This child had multiple adverse reactions/symptoms, including headache, and it was not clear which particular event led to discontinuation.1

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 (home or school).6

In the pediatric real-world study, the main safety analysis population included 14 children or adolescents, and adverse reactions were solicited using the Hypoglycemia Episode Questionnaire.1

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.1

References

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

2. Suico J, Hovelmann U, Zhang S, et al. Nasal glucagon: a viable alternative to treat insulin-induced hypoglycemia in adults with type 1 diabetes. Talk presented at: Proceedings from the European Association for the Study of Diabetes; October 1-5, 2018; Berlin.

3. Rickels 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

4. Seaquist 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

5. Sherr 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

6. Deeb 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

Glossary

BG = blood glucose

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24


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