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.
  • 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.

SELECT IMPORTANT SAFETY INFORMATION

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.

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.

Indications and Important Safety Information

Clinical use:
BAQSIMI has not been studied in pediatric patients less than 4 years old.

Limited clinical trial experience has not identified difference in responses between elderly (≥65 years of age) and younger patients.


Contraindications:

  • Hypersensitivity to glucagon or to any ingredient in the formulation or container
  • Pheochromocytoma
  • Insulinoma

 


Most serious warnings and precautions:
Lack of response: BAQSIMI should be given only in patients where impaired consciousness precludes oral carbohydrates. After intranasal administration of BAQSIMI, the patient will normally respond within 15 minutes. If the patient does not respond within 15 minutes, intravenous glucose must be administered as soon as IV access can be established.

States of starvation, adrenal insufficiency or chronic hypoglycemia: Because glucagon is of little or no help in these cases, intravenous glucose should be used for the treatment of hypoglycemia in these conditions.


Other relevant warnings and precautions:

  • Cardiovascular effects
  • Driving and operating machinery
  • Pheochromocytoma
  • Insulinoma
  • Sensitivity and resistance to glucagon
  • Pregnant women
  • Breast-feeding
  • Pediatrics (<4 years of age)
  • Geriatrics (≥65 years of age)
  • Use in patients with Type 2 diabetes taking sulfonylureas
  • Use with alcohol
  • Monitoring and laboratory tests

 


For more information:
Consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00074561.PDF for additional important information relating to warnings and precautions, adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-423-4136.

Indications and Important Safety Information

Clinical use:
BAQSIMI has not been studied in pediatric patients less than 4 years old.

Limited clinical trial experience has not identified difference in responses between elderly (≥65 years of age) and younger patients.


Contraindications:

  • Hypersensitivity to glucagon or to any ingredient in the formulation or container
  • Pheochromocytoma
  • Insulinoma

 


Most serious warnings and precautions:
Lack of response: BAQSIMI should be given only in patients where impaired consciousness precludes oral carbohydrates. After intranasal administration of BAQSIMI, the patient will normally respond within 15 minutes. If the patient does not respond within 15 minutes, intravenous glucose must be administered as soon as IV access can be established.

States of starvation, adrenal insufficiency or chronic hypoglycemia: Because glucagon is of little or no help in these cases, intravenous glucose should be used for the treatment of hypoglycemia in these conditions.


Other relevant warnings and precautions:

  • Cardiovascular effects
  • Driving and operating machinery
  • Pheochromocytoma
  • Insulinoma
  • Sensitivity and resistance to glucagon
  • Pregnant women
  • Breast-feeding
  • Pediatrics (<4 years of age)
  • Geriatrics (≥65 years of age)
  • Use in patients with Type 2 diabetes taking sulfonylureas
  • Use with alcohol
  • Monitoring and laboratory tests

 


For more information:
Consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00074561.PDF for additional important information relating to warnings and precautions, adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-423-4136.