For Consumers

Using Baqsimi

Using BAQSIMI: The simplicity of nasal administration1


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:

Remove the Shrink Wrap by pulling on the red stripe.
Preparing the dose
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

Hold Device between fingers and thumb. Do not push Plunger yet.
Insert Tip gently in one nostril until finger(s) touch the outside of the 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.
  • When they are able to safely swallow food or drink, give the person a fast-acting source of sugar, such as a regular soft drink or fruit juice and a long-acting source of sugar (such as crackers with cheese or peanut butter). If the person does not respond after 15 minutes, another dose of BAQSIMI from a new device may be given, if available while waiting for emergency services.
Click here to read the Safety Instructions

SELECT IMPORTANT SAFETY INFORMATION

Contraindications

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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.

Glucagon is delivered to the bloodstream via nasal administration

BAQSIMI is absorbed passively through the mucosal membrane of the nose2,3

The nasal mucosa is highly penetrable due to its large surface area and rich vascularization4,5
Lipophilic drugs like BAQSIMI are well absorbed from the nasal cavity2,3
When BAQSIMI permeates the nasal mucosa, it is distributed into the bloodstream

How all formulations of glucagon work

Glucagon binds to and activates hepatic glucagon receptors

This stimulates glycogen breakdown and release of glucose from the liver2
This in turn produces an antihypoglycemic effect2

References:

  1. Baqsimi. Instructions For Use. Amphastar Pharmaceuticals, Inc.
  2. Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
  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.
  4. 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.
  5. Bitter C, Suter-Zimmermann K, Surber C. Nasal drug delivery in humans. Curr Probl Dermatol. 2011;40:20-35.

Safety Summary

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. 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.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

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.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

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.

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 1 year and above.

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. 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.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

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.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

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.

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 1 year and above.

Baqsimi
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