For Healthcare Providers

Pediatric Safety

BAQSIMI Adverse Reactions in Pediatric Patients

Adverse reactions (%) occurring in pediatric patients with an incidence of ≥5%

Adverse ReactionsBAQSIMI 3 mg (n=36) %INJECTABLE GLUCAGON (weight based) (n=24) %
Gastrointestinal disorders

Vomiting
Nausea
30.6%
16.7%
37.5%
33.3%
General disorders and administration site conditions

Injection site discomfort


0


20.8%
Nervous system disorders

Headache

25.0%

12.5%
Respiratory, thoracic and mediastinal disorders

Nasal Discomfort
Nasal Congestion


8.3%
5.6%


0%
0%
Continue to Pediatric Administration/Usage

Indications and Important Safety Information

Clinical use:
BAQSIMI has not been studied in pediatric patients less than 4 years old.

Limited clinical trial experience has not identified difference in responses between elderly (≥65 years of age) and younger patients.

Contraindications:

  • Hypersensitivity to glucagon or to any ingredient in the formulation or container
  • Pheochromocytoma
  • Insulinoma

 

Most serious warnings and precautions:
Lack of response: BAQSIMI should be given only in patients where impaired consciousness precludes oral carbohydrates. After intranasal administration of BAQSIMI, the patient will normally respond within 15 minutes. If the patient does not respond within 15 minutes, intravenous glucose must be administered as soon as IV access can be established.

States of starvation, adrenal insufficiency or chronic hypoglycemia: Because glucagon is of little or no help in these cases, intravenous glucose should be used for the treatment of hypoglycemia in these conditions.

Other relevant warnings and precautions:

  • Cardiovascular effects
  • Driving and operating machinery
  • Pheochromocytoma
  • Insulinoma
  • Sensitivity and resistance to glucagon
  • Pregnant women
  • Breast-feeding
  • Pediatrics (<4 years of age)
  • Geriatrics (≥65 years of age)
  • Use in patients with Type 2 diabetes taking sulfonylureas
  • Use with alcohol
  • Monitoring and laboratory tests

 

For more information:
Consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00074561.PDF for additional important information relating to warnings and precautions, adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-423-4136.

Indications and Important Safety Information

Clinical use:
BAQSIMI has not been studied in pediatric patients less than 4 years old.

Limited clinical trial experience has not identified difference in responses between elderly (≥65 years of age) and younger patients.

Contraindications:

  • Hypersensitivity to glucagon or to any ingredient in the formulation or container
  • Pheochromocytoma
  • Insulinoma

 

Most serious warnings and precautions:
Lack of response: BAQSIMI should be given only in patients where impaired consciousness precludes oral carbohydrates. After intranasal administration of BAQSIMI, the patient will normally respond within 15 minutes. If the patient does not respond within 15 minutes, intravenous glucose must be administered as soon as IV access can be established.

States of starvation, adrenal insufficiency or chronic hypoglycemia: Because glucagon is of little or no help in these cases, intravenous glucose should be used for the treatment of hypoglycemia in these conditions.

Other relevant warnings and precautions:

  • Cardiovascular effects
  • Driving and operating machinery
  • Pheochromocytoma
  • Insulinoma
  • Sensitivity and resistance to glucagon
  • Pregnant women
  • Breast-feeding
  • Pediatrics (<4 years of age)
  • Geriatrics (≥65 years of age)
  • Use in patients with Type 2 diabetes taking sulfonylureas
  • Use with alcohol
  • Monitoring and laboratory tests

 

For more information:
Consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00074561.PDF for additional important information relating to warnings and precautions, adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-423-4136.