Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Biverkningar

Illamående och kräkning är välkända biverkningar av glukagon; huvudvärk och nässymtom inträffade oftare med glukagon näspulver jämfört med IM-glukagon.

Detailed Information

The information contained and described here is a summary of different studies of adults, children and adolescents.

The most frequently reported adverse reactions are lacrimation increased (36 %), upper respiratory tract irritation (34 %), nausea (27 %), headache (21 %), and vomiting (16 %).1

Two similarly designed comparator-controlled studies evaluated the efficacy and safety of a single dose of NG compared to a 1 mg dose of IM glucagon in adults with DM.2,3

Another study evaluated the PK and PD as primary objectives and safety and efficacy as secondary objectives in pediatric population. 4

Real World-Use studies, both in adults and pediatrics, also form part of the information described below. 5,6

Adverse Reactions in Adults

Adult Pivotal Studies

One pivotal study, 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 1 of NG in adults collected the onset and resolution of spontaneously reported adverse reactions with date and time, thus enabling more precise estimates of event duration in minutes or hours.7

Another pivotal study, 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

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.7

Nausea and vomiting are well-known adverse reactions of glucagon administration. Headache and nasal symptoms occurred more frequently with NG, but were transient, resolving on the same day as onset (Table 1).7

Table 1. Pooled Spontaneously Reported Adverse Reactions (≥2%) in Adults With T1DM and T2DM in Study 1a and Study 2b7


NG 3 mg
(N=153)

NG 3 mg
(N=153)

NG 3 mg
(N=153)

IM Glucagon 1 mg
(N=151)

IM Glucagon 1 mg
(N=151)

IM Glucagon 1 mg
(N=151)

Adverse Reactions, n (%)

With events

Resolved <24 h

Resolved ≥24 h

With events

Resolved <24 h

Resolved ≥24 h

Nausea

40 (26.1)

37 (92.5)

3 (7.5)

51 (33.8)

50 (98.0)

1 (2.0)

Headache

28 (18.3)

24 (88.9)

3 (11.1)

14 (9.3)

11 (78.6)

3 (21.4)

Vomiting

23 (15.0)

22 (95.7)

1 (4.3)

21 (13.9)

20 (95.2)

1 (4.8)

Upper respiratory tract irritationc

19 (12.4)d

13 (68.4)

4 (21.1)

2 (1.3)

1 (50.0)

1 (50.0) 

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

a Study 1 of Baqsimi in adults collected the onset and resolution of spontaneously reported adverse reactions with date and time, thus enabling more precise estimates of event duration in minutes or hours.

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

c Upper respiratory tract irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis.

d Data was missing for 2 patients on resolution of upper respiratory tract irritation.

Nausea and vomiting, well-known adverse reactions of glucagon administration, occurred in both the NG and IM glucagon treatment groups. Most cases were transient and resolved in less than 3 hours in Study 1 (duration reported in terms of hours and minutes) and in less than 24 hours in Study 2 (duration reported in terms of onset and resolution date without specific time; if an event started and ended on the same day, the duration was less than 24 hours).7

Headache and upper respiratory tract irritation occurred more frequently with NG and most cases were transient and resolved in less than 3 hours in Study 1 and in less than 24 hours in Study 2.7

No serious adverse reactions were reported in Study 1 or Study 2 for either treatment group.2,3

Nasal and ocular symptoms were solicited through a patient questionnaire in Study 1 and Study 2 and these adverse reactions were more commonly reported with NG (Table 2).7

Table 2. Solicited Nasal and Non-Nasal Adverse Reactions in Adults With T1DM and T2DM Pooled From Study 1 and Study 27


NG 3 mg
(N=153)

NG 3 mg
(N=153)

IM Glucagon 1 mg
(N=151)

IM Glucagon 1 mg
(N=151)

Adverse Reactions

Any increase in symptom severity, m (%)a

Resolved or returned to baseline severity, n/m (%)b

Any increase in symptom severity, m (%)a

Resolved or returned to baseline severity, n/m (%)b

Watery eyes

90 (58.8)

59/90 (65.6)

3 (2.0)

3/3 (100.0)

Nasal congestion

65 (42.5)

25/65 (38.5)

9 (6.0)

3/9 (33.3)

Nasal itching

60 (39.2)

27/60 (45.0)

7 (4.6)

5/7 (71.4)

Runny nose

53 (34.6)

35/53 (66.0)

0 (0.0)

NA

Redness of eyes

38 (24.8)

22/38 (57.9)

4 (2.6)

4/4 (100.0)

Itchy eyes

33 (21.6) 

23/33 (69.7)

2 (1.3)

2/2 (100.0)

Sneezing

30 (19.6)

22/32 (68.8)

0 (0.0)

NA

Itching of throat

19 (12.4)

12/19 (63.2)

2 (1.3)

1/2 (50.0)

Itching of ears

5 (3.3)

3/5 (60.0)

1 (0.7)

1/1 (100.0)

Abbreviations: IM = intramuscular; m = number of patients who reported onset or worsening of the specific symptom during 90 minutes postdose; n = number of patients who reported resolution or return to baseline severity; NA = not applicable; NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe), at baseline or at any postdose time point up to 90 minutes after glucagon administration.

b Percentage of patients at 90 minutes who reported the resolution or return to baseline severity if they had reported onset or severity increase postdose.

Adult Real-World Use 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).6

Adverse reactions or symptoms were solicited through a questionnaire, with 87.8% of participants reporting at least 1 adverse reaction or symptom (Table 3). Most of the adverse reactions or symptoms were of low to moderate severity. The most commonly reported adverse reaction or symptom was nasal irritation, with it resolving in less than 1 hour in most participants.6

Table 3. Adult Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With NG Through Questionnaires6

Adverse Reaction, n (%) 

Total number of hypoglycemic events 
N=179
a

Nasal irritation

105 (58.7) 

Headache

58 (32.4) 

Nausea

24 (13.4) 

Vomiting

13 (7.3) 

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

a The main safety analysis included 74 adults who experienced a total of 179 hypoglycemic events.

No serious adverse reactions were reported.6

Adverse Reactions 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.4

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.7 

Nausea and vomiting are well-known adverse reactions of glucagon administration. Headache and nasal symptoms occurred more frequently with NG, but were transient, resolving on the same day as onset (Table 4).4

Table 4. Spontaneously Reported Adverse Reactions (≥2%) Occurring in Pediatric Patients With T1DM7


NG 3 mg
(n=36)

NG 3 mg
(n=36)

NG 3 mg
(n=36)

IM Glucagona
(n=24)

IM Glucagona
(n=24)

IM Glucagona
(n=24)

Adverse Reaction, n (%)

With events

Resolved <24 h

Resolved ≥24 h

With events

Resolved <24 h

Resolved ≥24 h

Vomiting

11 (30.6)

10 (90.9)

1 (9.1)

9 (37.5)

7 (77.8)

2 (22.2)

Headache

9 (25.0)

8 (88.9)

1 (11.1)

3 (12.5)

2 (66.7)

1 (33.3)

Nausea

6 (16.7)

6 (100.0)

NA

8 (33.3)

6 (75.0)

2 (25.0)

Upper respiratory tract irritationb

6 (16.7)

6 (100.0)

NA

0 (0.0)

NA

NA

Abbreviations: Baqsimi = Baqsimi™ (glucagon) nasal powder; IM = intramuscular; NA = not applicable; NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus.

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

b Upper respiratory tract irritation: nasal discomfort, nasal congestion, sneezing.

One serious adverse reaction was reported in a 7-year old child receiving IM glucagon who had a hypoglycemic event after receiving an insulin bolus with lunch. No serious adverse reactions were reported with NG.4

Nasal and ocular symptoms were solicited through a patient questionnaire and these adverse reactions were more commonly reported with NG (Table 5).4

Table 5. Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients With T1DM4,7


NG 3 mg
(n=36)

NG 3 mg
(n=36)

IM Glucagon
(n=24)

IM Glucagon
(n=24)

Adverse Reactions

Any increase in symptom severity, m (%)a

Resolved/returned to baseline severity, n/m (%)b

Any increase in symptom severity, m (%)a

Resolved/returned to baseline severity, n/m (%)b

Watery eyes

17 (47.2)

15/17 (88.2)

0.0

NA

Nasal congestion

15 (41.7)

7/15 (46.7)

0.0

NA

Nasal itching

10 (27.8)

7/10 (70.0)

1 (4.2)

1/1 (100.0)

Runny nose

9 (25.0)

8/9 (88.9)

0.0

NA

Sneezing

7 (19.4)

7/7 (100.0)

 1 (4.2)

1/1 (100.0)

Itchy eyes

6 (16.7)

5/6 (83.3)

3 (12.5)

3/3 (100.0)

Redness of eyes

5 (13.9)

2/5 (40.0)

0.0

NA

Itching of throat

1 (2.8)

1/1 (100.0)

1 (4.2)

1/1 (100.0)

Itching of ears

1 (2.8)

0/1 (0.0)

0.0

NA

Abbreviations: IM = intramuscular; m = number of patients who reported onset or worsening of the specific symptom during 90 minutes post dose; n = number of patients who reported resolution or return to baseline severity; NA = not applicable; NG = nasal glucagon (glucagon nasal powder); T1DM = type 1 diabetes mellitus.

a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe), at baseline or at any postdose time point up to 90 minutes after glucagon administration.

b Percentage of patients at 90 minutes who reported the resolution or return to baseline severity if they had reported onset or severity increase postdose.

Pediatric Real-World Use 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).5

Adverse reactions or symptoms were solicited through a questionnaire, with 100% of participants reporting at least 1 adverse reaction or symptom (Table 6). Approximately 60% of the adverse reactions or symptoms resolved in less than 1 hour and were of low to moderate severity.5

Table 6. Pediatric Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With NG Through Questionnaires5

Adverse Reaction, n (%) 

Total number of hypoglycemic events
N=33
a

Nasal discomfort 

28 (84.8) 

Headache 

18 (54.5) 

Nausea 

6 (18.2) 

Vomiting 

1 (3.0) 

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

a The main safety analysis included 14 children who experienced a total of 33 moderate hypoglycemic events. There were no severe hypoglycemic events.

No serious adverse reactions were reported.5

References

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

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. 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

5. 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

6. 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

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

Glossary

BG = blood glucose

DM = diabetes mellitus

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

PD = pharmacodynamic

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24


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