Pediatric Administration/Usage

BAQSIMI: Simple to administer

Caregivers should refer to all steps of the Patient Medication Information

Important:

  • Do not remove the shrink wrap or open the tube until ready to use
  • Do not press the plunger before insertion into the nose. Otherwise, the single dose in the device will be lost.

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
Do not test before use.

Caution: Do not press the plunger until ready to give the dose

Keep tube sealed until ready to use.

Giving the dose

Hold Device between fingers and thumb. Do not push Plunger yet. Otherwise, the single dose in the device will be lost.
Insert Tip gently in one nostril until finger(s) touch the outside of the nose.
Push Plunger firmly all the way in.

The dose is complete when the green line is no longer showing

Keep BAQSIMI in the shrink-wrapped tube until ready to use. If the tube has been opened, BAQSIMI may have been exposed to moisture. This could cause it to not work as expected.

After Giving the Dose:

  • Remove the tip from the nose and throw away the used device and tube.
  • Call for emergency medical help right away. If the person with low blood sugar is unconscious, turn the person on their side.
  • Medical help should be called immediately in the event of a serious allergic reaction to BAQSIMI, such as:
    • Rash
    • Difficulty Breathing
    • Swollen face, lip, tongue, or throat

Patients usually respond within 15 minutes. Encourage the person to eat as soon as they can safely swallow. Give the person a fast-acting source of sugar, like juice or regular soda. Then give the person a long-acting source of sugar, like crackers and cheese or a sandwich with meat.

Caution: The used BAQSIMI should be replaced right away so that a new BAQSIMI will be available in case it is needed.

Watch the following video to learn how to administer BAQSIMI

Simulated severe hypoglycemia rescue study*

Successful administration (% of participants who were able to deliver a full dose)

BAQSIMIINJECTABLE GLUCAGON
Trained caregivers (n=16)94%13%
Untrained individuals (n=15)93%0%
Mean time to administration by caregivers (minutes).271.89
*A study of administration rates, time to administration, and experience of administering BAQSIMI vs. injectable glucagon to a mannequin, by trained and untrained users, during a simulated severe hypoglycemia event. Trained caregivers received BAQSIMI and injectable glucagon administration instructions from the person with diabetes for whom they were caregivers. Untrained users were not associated with a person with diabetes, had no prior experience with glucagon, and were shown what each glucagon treatment looked like immediately before simulation. Data on file. Amphastar Pharmaceuticals, Inc.
p<0.001.

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.