BAQSIMI SIDE EFFECTS

  • Generic Name: glucagon nasal powder
  • Brand Name: Baqsimi
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Hypersensitivity and Allergic Reactions.

Clinical Trial Data

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflect the rates observed in practice.

Adverse Reactions In Adult Patients

Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes. Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and Study 2.

Table 1: Pooled Adverse Reactions (≥2%) in Adult Patients with Type 1 and Type 2 Diabetes in Study 1 and Study 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 and these 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 Diabetes Pooled 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, and after 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 patients with type 1 diabetes in Study 3 [see Clinical Studies].

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 in Study 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, and after 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).

Immunogenicity

As with all therapeutic peptides, there is the potential for immunogenicity. The detection of antibody formation is highly 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 assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to BAQSIMI with the incidences of antibodies to other products may be misleading.

In 3 clinical trials, 3/124 (2%) of BAQSIMI-treated patients had treatment-emergent anti-drug antibodies as detected by an affinity capture elution (ACE) ligand-binding immunogenicity assay. No neutralizing antibodies were detected.

DRUG INTERACTIONS

Beta-Blockers

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.

Indomethacin

In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia.

Warfarin

BAQSIMI may increase the anticoagulant effect of warfarin.

 

SRC: NLM .