Pediatric Efficacy – Baqsimi

BAQSIMI began raising mean plasma glucose as early as 5 minutes in patients ages 4 to <18

Nasal congestion does not impact the absorption of BAQSIMI

For young children aged 4 to <8 years old

The mean time to treatment success was 10.8 minutes for BAQSIMI and 10 minutes for intra-muscular glucagon.*^†‡§

For children aged 8 to <12 years old

The mean time to treatment success was 11.3 minutes for BAQSIMI and 12.5 minutes for intra-muscular glucagon.*^†‡§

For adolescents aged 12 to <18 years old

The mean time to treatment success was 14.2 minutes for BAQSIMI and 12.5 minutes for intra-muscular glucagon.*^†‡§

Continue to Pediatric Safety

* Study IGBB was a randomized, multicenter, open-label clinical study that assessed BAQSIMI compared to intra-muscular glucagon in pediatric patients aged 4 years and older with type 1 diabetes. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <4.4 mmol/L on the dosing day.
^† Patients receiving BAQSIMI aged 4 to <8 years (n=12), 8 to <12 years (n=12), and 12 to <18 years (n=12).
^‡ Patients receiving intra-muscular glucagon aged 4 to <8 years (n=6), 8 to <12 years (n=6), and 12 to <18 years (n=12).
^§ Treatment success was defined as the percentage of patients with a glucose increase of ≥1.1 mmol/L from glucose nadir within 30 minutes of glucagon administration.

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.