For Healthcare Providers

Adult Safety

BAQSIMI Adverse Reactions in Adult Patients

Adverse reactions (%) in adult Type 1 and Type 2 diabetes patients with an incidence ≥5%

Adverse ReactionsIGBC Type 1 and Type 2 diabetes
BAQSIMI 3 mg (n=83) %		IGBC Type 1 and Type 2 diabetes
INJECTABLE GLUCAGON weight based (n=82) %
Eye Disorders

Lacrimation increased		8.4%1.2%
Gastrointestinal disorders

Nausea
Vomiting		21.7%
15.7%		26.8%
11.0%
General disorders and administration site conditions

Fatigue		8.4%8.5%
Nervous system disorders

Headache		20.5%8.5%
Respiratory, thoracic, and mediastinal disorders

Nasal discomfort
Nasal congestion		9.6%
8.4%		0%
1.2%
Continue to Adult 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.