Pediatric Adverse Reaction
BAQSIMI adverse reactions in pediatric patients
Adverse Reactions (%)
|Spontaneous Adverse Reactions||BAQSIMI 3 mg1|
|Glucagon for injection2|
|Upper Respiratory Tract Irritation*||16.7%||0%|
Questionnaire-Solicited Adverse Reactions1,2
Treatment-emergent nasal and ocular symptoms to be aware of were identified using a questionnaire. BAQSIMI included Watery Eyes (47.2%), Nasal Congestion (41.7%), Nasal Itching (27.8%), Runny Nose (25.0%), Sneezing (19.4%), Itchy Eyes (16.7%), Redness of Eyes (13.9%), Itching of Throat (2.8%), and Itching of Ears (2.8%). Glucagon for injection included Nasal Itching (4.2%), Sneezing (4.2%), Itchy Eyes (12.5%), and Itching of Throat (4.2%); Watery Eyes, Nasal Congestion, Runny Nose, Redness of Eyes, and Itching of Ears were not reported.†
*Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing.
†Subjects were asked to report whether they have the symptom after glucagon administration. The frequency was based on severity increased over baseline.
SELECT IMPORTANT SAFETY INFORMATION
BAQSIMI is contraindicated in patients with pheochromocytoma because of risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.
- Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
- Data on File, Amphastar Pharmaceuticals, Inc.