BAQSIMI adverse reactions in adult patients
Pooled Results for Study 1 and Study 2 | ||
---|---|---|
Spontaneous Adverse Reactions | BAQSIMI 3 mg1 (n=153) | Glucagon for injection 1 mg2 (n=151) |
Spontaneous Adverse Reactions: Nausea | Pooled Results for Study 1 and Study 2 BAQSIMI 3 mg1 (n=153): 26.1% | Glucagon for injection 1 mg2 (n=151): 33.8% |
Spontaneous Adverse Reactions: Headache | Pooled Results for Study 1 and Study 2 BAQSIMI 3 mg1 (n=153): 18.3% | Glucagon for injection 1 mg2 (n=151): 9.3% |
Spontaneous Adverse Reactions: Vomiting | Pooled Results for Study 1 and Study 2 BAQSIMI 3 mg1 (n=153): 15.0% | Glucagon for injection 1 mg2 (n=151): 13.9% |
Spontaneous Adverse Reactions: Upper Respiratory Tract Irritation* | Pooled Results for Study 1 and Study 2 BAQSIMI 3 mg1 (n=153): 12.4% | Glucagon for injection 1 mg2 (n=151): 1.3% |
Questionnaire-Solicited Adverse Reactions1,2
Treatment-emergent nasal and ocular symptoms to be aware of were identified using a questionnaire. BAQSIMI included Watery Eyes (58.8%), Nasal Congestion (42.5%), Nasal Itching (39.2%), Runny Nose (34.6%), Redness of Eyes (24.8%), Itchy Eyes (21.6%), Sneezing (19.6%), Itching of Throat (12.4%), and Itching of Ears (3.3%). Glucagon for injection included Watery Eyes (2.0%), Nasal Congestion (6.0%), Nasal Itching (4.6%), Redness of Eyes (2.6%), Itchy Eyes (1.3%), Itching of Throat (1.3%), and Itching of Ears (0.7%); Sneezing and Runny Nose were not reported.†
Most BAQSIMI adverse reactions were transient, resolving within 3 hours3,‡
*Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis.
†Subjects were asked to report whether they have the symptom after glucagon administration. The frequency is based on severity increase over baseline.
‡In Study 1, where event duration was reported in terms of minutes and hours.
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
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.
References:
- Baqsimi. Prescribing Information. Lilly USA, LLC.
- Data on File, Lilly USA, LLC, DOF-GN-US-0005.
- Data on File, Lilly USA, LLC, DOF-GN-US-0009.