Designed to be simple in a severe hypoglycemia rescue

Product features¹:

Dry nasal powder form of glucagon
No inhalation required—absorbed passively in the nose
Single, fixed, 3 mg dose
Ready to use with no reconstitution or priming
Does not need to be refrigerated, store at temperatures up to 86°F (30°C) in the shrink-wrapped tube provided

BAQSIMI can be used for 2 years from the date of manufacture. Instruct patients to check the expiration date on the BAQSIMI tube and carton before use.^1,3

Child administering BAQSIMI emergency glucagon on an adult

INDICATION

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

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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.

In a severe hypoglycemia emergency, BAQSIMI offers:

Treatment success^† for BAQSIMI and glucagon for injection

Two bar graphs show measures of treatment success for BAQSIMI (3 milligrams) and for glucagon for injection (1 milligram). In Study 1, 100 percent of patients treated with BAQSIMI and 100 percent of patients treated with glucagon for injection achieved treatment success as defined in the study. In Study 2, 98.8 percent of patients treated with BAQSIMI and 100 percent of patients treated with glucagon for injection achieved treatment success as defined in the study.

^*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 44.2 mg/dL for BAQSIMI and 47.2 mg/dL for glucagon for injection.

^†Treatment success was defined as 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.

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; 66 patients were included in the efficacy analysis. 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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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.

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References:

Baqsimi. Prescribing Information. Lilly USA, LLC.
Pack BW, Melnick J, Breen C, Allen R. Portability of nasal glucagon for the rescue of severe hypoglycemia: stability and performance evaluation across a broad range of temperatures. Diabetes. 2021; 70(suppl 1).
Data on File, Lilly USA, LLC, DOF-GN-US-0019.
Baqsimi. Instructions For Use. Lilly USA, LLC.

IMPORTANT SAFETY 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.

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 14SEP2022

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

INDICATION

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

Designed to be simple in a severe hypoglycemia rescue

Product features¹:

In a severe hypoglycemia emergency, BAQSIMI offers:

Treatment success^† for BAQSIMI and glucagon for injection

Be prepared with BAQSIMI. The first and only dry nasal spray to treat low blood sugar emergencies

Before BAQSIMI is needed:

Important information to know:

Preparing the dose:

Giving the dose:

After giving BAQSIMI:

Continue to Adult Clinical Trials →

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Adverse Reactions

Drug Interactions

INDICATION

Designed to be simple in a severe hypoglycemia rescue

Product features1:

In a severe hypoglycemia emergency, BAQSIMI offers:

Expand accordion 1. Comparable efficacy to glucagon for injection in adults1,*

Treatment success† for BAQSIMI and glucagon for injection

Expand accordion 2. Portable dry nasal spray glucagon1,2

Be prepared with BAQSIMI. The first and only dry nasal spray to treat low blood sugar emergencies

Expand accordion 3. Simplicity of nasal administration2,4

Before BAQSIMI is needed:

Important information to know:

Preparing the dose:

Giving the dose:

After giving BAQSIMI:

Continue to Adult Clinical Trials →

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Adverse Reactions

Drug Interactions

INDICATION

Product features¹:

Treatment success^† for BAQSIMI and glucagon for injection