Administering BAQSIMI: A simulated rescue study


Users were assessed on ability to administer BAQSIMI2

Successful Administration* (%)

chart showing successful administration rates for BAQSIMI versus glucagen hypokit

*Successful administration analysis includes those who located the device and attempted administration. It was defined as the delivery of a complete dose of study glucagon with all critical administration steps fulfilled.

GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S.

Study Design

  • A randomized, single-center, crossover, 2-cohort user-experience study that compared successful administration rates, time to and experience of administering BAQSIMI versus injectable glucagon during simulated severe hypoglycemia
  • Patient-trained users (n=33) received instructions by associated persons with diabetes on how to use either BAQSIMI or injectable glucagon. One week later, users were asked to administer the device on a manikin in a simulated severe hypoglycemia emergency
  • Untrained users (n=33) were not associated with a person with diabetes and were shown the device immediately before simulation
  • After 1 week, processes for both groups were repeated with the other glucagon device. All users and associated patients with diabetes were adults
  • The primary endpoint was the proportion of trained users who successfully administered the study glucagon (complete dose and critical steps performed)
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions (continued)
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.

Nasal administration of a rescue treatment for severe hypoglycemia

Nasal delivery of glucagon

BAQSIMI is absorbed passively through the mucosal membrane of the nose3,4

line drawing of a nose

The nasal mucosa is highly penetrable due to its large surface area and rich vascularization5,6

line drawing of a line chart showing absorption rates

Lipophilic drugs like nasal glucagon are well absorbed from the nasal cavity3,4

line drawing of glucagon powder in the bloodstream

When BAQSIMI permeates the nasal mucosa, it is distributed into the bloodstream

How all formations of glucagon work

Glucagon binds to and activates hepatic glucagon receptors

line drawing of a liver

This stimulates glycogen breakdown and release of glucose from the liver3

line drawing of an arrow

This in turn produces an antihypoglycemic effect3

SELECT IMPORTANT SAFETY INFORMATION

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.


References: 1. Baqsimi [Instructions For Use], Indianapolis, IN: Lilly USA, LLC. 2. Data on File, Lilly USA, LLC, DOF-GN-US-0011. 3. Baqsimi [Prescribing Information], Indianapolis, IN: Lilly USA, LLC. 4. 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. 5. Yuba E, Kona K. Nasal delivery of biopharmaceuticals. In: das Neves J, Sarmento B, eds. Mucosal Delivery of Biopharmaceuticals—Biology, Challenges and Strategies. New York, NY: Springer Publishing Co; 2014:197-220. 6. Bitter C, Suter-Zimmermann K, Surber C. Nasal drug delivery in humans. Curr Probl Dermatol. 2011;40:20-35.

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.