y 2
Adverse Reaction
BAQSIMI 3 mg
(N=153)
%
Nausea 26.1
Headache 18.3
Vomiting 15.0
Upper Respiratory Tract Irritationa
12.4
a Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis.
Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in Study 1 and 2 andthese adverse reactions are presented in Table 2.
Table 2: Solicited Nasal and Non-Nasal Adverse Reactions in Adult Patients with Type 1 and Type 2 DiabetesPooled from Study 1 and 2
Adverse Reactiona BAQSIMI 3 mg
(n=153)
%
Any increase in symptom severitya
Watery eyes 58.8
Nasal congestion 42.5
Nasal itching 39.2
Runny nose 34.6
Redness of eyes 24.8
Itchy eyes 21.6
Sneezing 19.6
Itching of throat 12.4
Itching of ears 3.3
a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, andafter glucagon administration.
Adverse Reactions in Pediatric Patients Aged 4 Years and Above
A single dose of BAQSIMI was compared to weight-based doses of 0.5 mg or 1 mg of IMG in pediatric patientswith type 1 diabetes in Study 3 [see Clinical Studies (14)].
Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of ≥2% in
Study 3.
Table 3: Adverse Reactions (≥2%) Occurring in Pediatric Patients with Type 1 Diabetes in Study 3
Adverse Reaction
BAQSIMI 3 mg
(n=36)
%
Vomiting 30.6
Headache 25.0
Nausea 16.7
Upper Respiratory Tract Irritationa
16.7
a Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing.
Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in pediatric patients inStudy 3 and these adverse reactions are presented in Table 4.
Table 4: Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients with Type 1 Diabetes in Study 3
Adverse Reactiona BAQSIMI 3 mg
(n=36)
%
Any increase in symptom severitya
Watery eyes 47.2
Nasal congestion 41.7
Nasal itching 27.8
Runny nose 25.0
Sneezing 19.4
Itchy eyes 16.7
Redness of eyes 13.9
Itching of throat 2.8
Itching of ears 2.8
a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, andafter glucagon administration.
Other Adverse Reactions in Adult and Pediatric Patients
Other observed adverse reactions with BAQSIMI-treated patients across clinical trials were, dysgeusia, pruritus,tachycardia, hypertension, and additional upper respiratory tract irritation events (nasal pruritus, throat irritation,and parosmia).
6.2 Immunogenicity
As with all therapeutic peptides, there is the potential for immunogenicity. The detection of antibody formation ishighly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody(including neutralizing antibody) positivity in an assay may be influenced by several factors including assaymethodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Forthese reasons, comparison of incidence of antibodies to BAQSIMI with the incidences of antibodies to otherproducts may be misleading.
In 3 clinical trials, 3/124 (2%) of BAQSIMI-treated patients had treatment-emergent anti-drug antibodies asdetected by an affinity capture eluti |
