FDA Approval Status for Children
Baqsimi (nasal glucagon) is approved by the FDA for treating severe hypoglycemia in patients aged 4 years and older. It is not approved for children under 4.[1][2]
Clinical Data in Pediatric Patients
Safety and effectiveness were studied in children aged 4 and older, including a trial with 14 participants aged 4-11. No serious adverse reactions occurred, and the most common side effects—headache, nausea, and vomiting—matched those in adults. The nasal delivery avoided injection risks like needle phobia in kids.[2][3]
Common Side Effects Kids Experience
Children may face the same issues as adults: upper respiratory irritation, nausea (up to 15%), vomiting (up to 10%), headache (up to 10%), and runny nose. These are usually mild and short-lived.[2]
Risks and Precautions for Young Patients
Use caution in kids under 18 due to higher rates of respiratory issues or vomiting, which could lead to aspiration. It's contraindicated in pheochromocytoma or insulinoma cases. Always seek emergency help after use, as effects last 1-2 hours.[1][2] No long-term pediatric safety data exists beyond trials.
How It Compares to Injectable Glucagon for Kids
Baqsimi offers needle-free administration, preferred for children scared of shots. Both reverse hypoglycemia similarly, but Baqsimi's nasal form succeeds in 90% of pediatric cases within 20 minutes.[3]
Who Makes Baqsimi and Availability
Eli Lilly manufactures Baqsimi. It's prescription-only, available in single-dose nasal sprays.[1]
[1]: FDA Label for Baqsimi
[2]: Drugs.com - Baqsimi
[3]: Eli Lilly Prescribing Information