[GLOBAL ON SCREEN THROUGHOUT VIDEO:] Please see the Important Safety Information within this video and the Full Prescribing Information including Patient Information and Instructions for Use by clicking the links provided.
Hello, and thank you for taking the time to view this video. My name is Michael Davidson, and I’m an adult endocrinologist at Wentworth Health Partners Endocrinology and Diabetes Consultants.
Today, I would like to introduce you to BAQSIMI, the first and only glucagon with nasal administration.
In this video, we will cover key product features, clinical trial data, and the usage and administration of BAQSIMI.
This program is sponsored by, and presented on behalf of, Lilly USA, LLC. It is being presented consistent with the FDA guidelines and is not approved for continuing education credit.
Please see the Important Safety Information within this video and the Full Prescribing Information including Patient Information and Instructions for Use by clicking the links provided.
BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above.
Before moving on, let’s review some Important Safety Information from the BAQSIMI prescribing 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.
First, let’s review the key product features of BAQSIMI.
BAQSIMI is designed to be simple in a severe hypoglycemia rescue.
Unlike other forms of glucagon, BAQSIMI is not an injection. It is a dry nasal powder form of glucagon that is absorbed passively in the nose, with no inhalation required.
BAQSIMI is supplied in a single, fixed 3 milligram dose that is ready to use, with no reconstitution or priming.
BAQSIMI also offers wide temperature-stable portability. It does not need to be refrigerated and patients can carry it with them throughout the day, in hot or cold conditions, and store it up to 86 degrees Fahrenheit. BAQSIMI can even be carried in freezing temperatures. In a study, BAQSIMI was exposed to freezing temperatures as low as -4°F (or -20° centigrade) with no adverse effects to the physical, chemical, or performance characteristics of the product.
Now, let’s discuss BAQSIMI clinical trial data in adult patients.
Two randomized, multicenter, open-label, 2-period crossover trials compared a 3 milligram dose of nasally administered BAQSIMI to a 1 milligram dose of intramuscular glucagon for injection for the treatment of insulin-induced hypoglycemia.
Study 1 included 70 adults with type 1 diabetes, of which 66 were included in the efficacy analysis. Study 2 included 83 adults with type 1 or type 2 diabetes, of which 80 patients were included in the efficacy analysis.
The primary efficacy measure was the proportion of patients achieving treatment success, which was defined as an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from the glucose nadir within 30 minutes of receiving the study glucagon.
In both clinical studies, BAQSIMI demonstrated comparable efficacy to glucagon for injection.
100% of patients achieved treatment success in study 1.
98.8% and 100% achieved treatment success in the BAQSIMI and glucagon for injection arms, respectively, in study 2.
In the same studies, plasma glucose concentrations were measured before the administration of glucagon and at various time intervals until 90 minutes after administration.
Mean plasma glucose concentrations over time with BAQSIMI and glucagon for injection in patients in study 1 are shown here. In study 1, the mean time to treatment success was 11.6 minutes for BAQSIMI and 9.9 minutes for glucagon for injection. Across studies, the mean time to treatment success for BAQSIMI was a range of 11.6 to 15.9 minutes.
Common cold with nasal congestion, tested with or without the use of a decongestant, did not impact the absorption of BAQSIMI.
A single-center, open-label phase 1 study examined the safety profile and pharmacokinetic/pharmacodynamic properties of a single 3 milligram dose of BAQSIMI in otherwise healthy participants with nasal congestion resulting from the common cold. A total of 36 adult patients were enrolled in this study, 18 in each cohort.
The primary efficacy measure was the glucose response within the first 30 minutes.
At 30 minutes, the glucose response was similar among the cohorts.
This table shows adverse reactions that occurred in adult patients in study 1 and study 2, including nausea, headache, vomiting, and upper respiratory tract irritation. Most adverse reactions were transient, resolving within 3 hours.
Data from a patient-solicited questionnaire are also shown, which predominately describe nasal and ocular symptoms associated with BAQSIMI.
Now that we have discussed efficacy and safety, let’s review the usage and administration of BAQSIMI.
Here is some important information to know:
Do not remove the shrink wrap or open the tube until you are ready to use it.
Do not push the plunger until you are ready to give the dose.
If the tube has been opened, BAQSIMI could be exposed to moisture. This could cause BAQSIMI not to work as expected.
The process to use BAQSIMI is as follows.
First, remove the shrink wrap by pulling on the red stripe. Open the lid and remove the device from the tube.
In order to administer BAQSIMI, hold the device between your fingers and thumb. Do not push the plunger yet.
Insert the tip gently into one nostril until your finger or fingers touch the outside of the nose.
Push the plunger firmly all the way in. The dose is complete when the green line disappears.
Instruct patients to read the Instructions for Use for BAQSIMI before using it. They should also make sure they show their caregivers, family, and friends where they keep BAQSIMI and explain how to use it by sharing these instructions. They need to know how to use BAQSIMI before an emergency happens.
After giving BAQSIMI, emergency medical help should be called right away. If the person is unconscious, they should be turned on their side. The device and tube should be thrown away.
Encourage the person to eat as soon as possible. When they are able to safely swallow, give the person a fast-acting source of sugar, such as juice. Then encourage the person to eat a snack, such as crackers with cheese or peanut butter.
If the person does not respond after 15 minutes, another dose may be given, if available. Please ensure you review BAQSIMI’s Instructions for Use with your patients and with those around them.
To summarize, BAQSIMI offers wide temperature-stable portability, comparable efficacy to glucagon for injection, and the simplicity of nasal administration in a severe hypoglycemia emergency.
Help prepare your patients and those around them by prescribing BAQSIMI.
[Warnings and Precautions]
BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate the 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.
[Scrolling ISI appears.]