BAQSIMI demonstrated noninferiority to glucagon for injection in treating insulin-induced hypoglycemia in Adults*1


Treatment Success for BAQSIMI and glucagon for injection

bar chart showing 100% treatment success for BAQSIMI versus glucagon for injection

Treatment success was the proportion of participants achieving either an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes of receiving the study glucagon.

*In study 1, the mean nadir blood glucose was 54.5 mg/dL for BAQSIMI and 55.8 mg/dL for glucagon for injection. In study 2, the mean nadir blood glucose was 44.1 mg/dL for BAQSIMI and 47.1 mg/dL for glucagon for injection.1,2

Study Design
  • Two randomized, multicenter, open-label, 2-period crossover trials compared a 3 mg dose of nasally administered BAQSIMI to a 1 mg dose of glucagon for injection (IM) for treatment of insulin-induced hypoglycemia
  • Study 1 included 70 adult patients with type 1 diabetes. Study 2 included 83 adult patients with type 1 or type 2 diabetes; 80 patients were included in the efficacy analysis
  • Primary efficacy measure was the proportion of patients achieving treatment success
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Contraindications
BAQSIMI is contraindicated in patients with pheochromocytoma, insulinoma, 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 dramatic 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.

Mean plasma glucose concentrations over time with BAQSIMI and glucagon for injection1

Study 1 - Mean Plasma Glucose Concentrations

line chart showing BAQSIMI raising mean plasma glucose as early as 5 minutes
Study Design
  • A randomized, multicenter, open-label, 2-period crossover trial compared a 3 mg dose of nasally administered BAQSIMI to a 1 mg dose of glucagon for injection (IM) for treatment of insulin-induced hypoglycemia in 66 patients with type 1 diabetes
  • Treatment success was the proportion of participants achieving either an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes of receiving the study glucagon
  • Plasma glucose and glucose concentrations were measured prior to administration of glucose (t=0, glucose concentration<60 mg/dL) and at 5-, 10-, and 30-minute intervals until 90 minutes after administration4

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Warnings and Precautions (continued)
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.

Common cold with nasal congestion did not impact absorption of BAQSIMI3

Glucose Concentrations Over Time Following BAQSIMI Administration

line chart showing glucose concentrations of BAQSIMI in patients with nasal congestion

References: 1. Baqsimi [Prescribing Information], Indianapolis, IN: Lilly USA, LLC. 2. Data on File, Lilly USA, LLC, DOF-GN-US-0003. 3. Guzman CB, Dulude H, Piché C, et al. Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: a randomized clinical trial. Diabetes Obes Metab. 2018;20(3):646-653.

Study Design
  • A randomized, single-center, open-label, repeated-measures, parallel-design, phase I study examining the safety and PK/PD of a single BAQSIMI 3 mg dose in otherwise healthy adult participants with nasal congestion resulting from common cold3
  • Adult patients in cohort 1 (n=18) received 2 doses BAQSIMI 3 mg: one while experiencing nasal congestion and another after recovery from cold symptoms3
  • Adult patients in cohort 2 (n=18), who also had colds with nasal congestion, received a single dose of BAQSIMI 3 mg two hours after treatment with the decongestant oxymetazoline3
  • Blood glucagon and glucose concentrations were measured before and at 5-, 10-, and 30-minute intervals until 180 minutes after BAQSIMI administration3

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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.

INDICATION AND IMPORTANT SAFETY INFORMATION
Indication and Important Safety Information

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

Important Safety Information
Contraindications
BAQSIMI is contraindicated in patients with pheochromocytoma, insulinoma, 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 dramatic 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 24JUL2019

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