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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.

BAQSIMI delivery device and carrying case

Designed to be simple in severe hypoglycemia rescue

BAQSIMI1:


  • 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

In a severe hypoglycemia emergency, BAQSIMI offers:

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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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.

BAQSIMI portable rescue device
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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.

Before BAQSIMI is needed:

  • Read the Instructions for Use for BAQSIMI before using it.
  • You should make sure you show your caregivers, family and friends where you keep BAQSIMI and explain how to use it by sharing these instructions. They need to know how to use BAQSIMI before an emergency happens.

Important information to know:

  • Do not remove the Shrink Wrap or open the Tube until you are ready to use it.
  • If the Tube has been opened, BAQSIMI could be exposed to moisture. This could cause BAQSIMI not to work as expected.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.

Preparing the dose:

Removing shrink-wrap from BAQSIMI device

Remove the Shrink Wrap by pulling on the red stripe.

BAQSIMI device out of tube

Open the Lid and remove the Device from the Tube.

Caution: Do not press the Plunger until ready to give the dose.

Giving the dose:

BAQSIMI device in hand

Hold Device between fingers and thumb.

Do not push Plunger yet.

BAQSIMI device in nose

Insert Tip gently into one nostril until finger(s) touch the outside of the nose.

BAQSIMI device sprayed in nose

Push Plunger firmly all the way in.

Dose is complete when the Green Line disappears.

After giving BAQSIMI:

  • Call for emergency medical help right away.
  • If the person is unconscious turn the person on their side.
  • Throw away the used Device and Tube.
  • 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.
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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 [Prescribing Information], Indianapolis, IN: Lilly USA, LLC. 2. Data on File, Lilly USA, LLC, DOF-GN-US-0003. 3. Baqsimi [Instructions For Use], Indianapolis, IN: Lilly USA, LLC.

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.