BAQSIMI adverse reactions in pediatric patients

Adverse Reactions (%)

Spontaneous Adverse Reactions BAQSIMI 3 mg1
(n=36)
Glucagon for injection2
weight-based (n=24)
Spontaneous Adverse Reactions:
Vomiting
BAQSIMI 3 mg1
(n=36):
30.6%

Glucagon for injection2
weight-based (n=24):
37.5%
Spontaneous Adverse Reactions:
Headache
BAQSIMI 3 mg1
(n=36):
25.0%

Glucagon for injection2
weight-based (n=24):
12.5%
Spontaneous Adverse Reactions:
Nausea
BAQSIMI 3 mg1
(n=36):
16.7%

Glucagon for injection2
weight-based (n=24):
33.3%
Spontaneous Adverse Reactions:
Upper Respiratory Tract Irritation*
BAQSIMI 3 mg1
(n=36):
16.7%

Glucagon for injection2
weight-based (n=24):
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

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:

  1. Baqsimi. Prescribing Information. Lilly USA, LLC.
  2. Data on File, Lilly USA, LLC, DOF-GN-US-0006.

INDICATION

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above.

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.

Warnings and Precautions

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction.

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Adverse Reactions

Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. BAQSIMI may increase the anticoagulant effect of warfarin.

GN HCP ISI NOV2020

Please see Full Prescribing Information including Patient Information provided. Please see Instructions for Use included with the device.