BAQSIMI Adverse Reactions in Pediatric Patients
Adverse reactions (%) occurring in pediatric patients with an incidence of ≥5%
Adverse Reactions
|
BAQSIMI 3 mg (n=36) %
|
INJECTABLE GLUCAGON (weight based) (n=24) %
|
|---|---|---|
| Adverse Reactions Gastrointestinal disorders | BAQSIMI 3 mg (n=36) % | INJECTABLE GLUCAGON (weight based) (n=24) % |
| Adverse Reactions Vomiting | BAQSIMI 3 mg (n=36) % 30.6 | INJECTABLE GLUCAGON (weight based) (n=24) % 37.5 |
| Adverse Reactions Nausea | BAQSIMI 3 mg (n=36) % 16.7 | INJECTABLE GLUCAGON (weight based) (n=24) % 33.3 |
| Adverse Reactions General disorders and administration site conditions | BAQSIMI 3 mg (n=36) % | INJECTABLE GLUCAGON (weight based) (n=24) % |
| Adverse Reactions Injection site discomfort | BAQSIMI 3 mg (n=36) % 0 | INJECTABLE GLUCAGON (weight based) (n=24) % 20.8 |
| Adverse Reactions Nervous system disorders | BAQSIMI 3 mg (n=36) % | INJECTABLE GLUCAGON (weight based) (n=24) % |
| Adverse Reactions Headache | BAQSIMI 3 mg (n=36) % 25.0 | INJECTABLE GLUCAGON (weight based) (n=24) % 12.5 |
| Adverse Reactions Respiratory, thoracic and mediastinal disorders | BAQSIMI 3 mg (n=36) % | INJECTABLE GLUCAGON (weight based) (n=24) % |
| Adverse Reactions Nasal discomfort | BAQSIMI 3 mg (n=36) % 8.3 | INJECTABLE GLUCAGON (weight based) (n=24) % 0 |
| Adverse Reactions Nasal congestion | BAQSIMI 3 mg (n=36) % 5.6 | INJECTABLE GLUCAGON (weight based) (n=24) % 0 |
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
http://pi.lilly.com/ca/baqsimi-ca-pm.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 1-888-545-5972.