Baqsimi glucagon

Get an overview of BAQSIMI (glucagon powder), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Baqsimi can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Baqsimi.

Drug Basics

Brand Name: Baqsimi

Generic Name: GLUCAGON

Drug Type: HUMAN PRESCRIPTION DRUG

Route: NASAL

Dosage Form: POWDER

Packager: Eli Lilly and Company

Data Current As Of: 2021-08-30

Indications & Usage

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

BAQSIMI™ is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above. (1)

Drug Interactions

  • Beta-blockers: Patients taking beta-blockers may have a transient increase in pulse and blood pressure. (7.1)
  • Indomethacin: In patients taking indomethacin BAQSIMI may lose its ability to raise glucose or may produce hypoglycemia. (7.2)
  • Warfarin: BAQSIMI may increase the anticoagulant effect of warfarin. (7.3)

beta-blockers

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.

indomethacin

In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia.

warfarin

BAQSIMI may increase the anticoagulant effect of warfarin.

Patient Counseling Information

Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Recognition of Severe Hypoglycemia:

Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Administration:

Review the Patient Information and Instructions for Use with the patient and family members or caregivers.

Serious Hypersensitivity:

Inform patients that allergic reactions can occur with BAQSIMI. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

Literature revised: October 2020

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2019, 2020, Eli Lilly and Company. All rights reserved.

BAQ-0002-USPI-20201027

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: July 2019

PATIENT INFORMATION
BAQSIMI™ (BAK-see-mee)
(glucagon) nasal powder
What is BAQSIMI?
BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.
It is not known if BAQSIMI is safe and effective in children under 4 years of age.
Do not use BAQSIMI if you:
  • have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • have a tumor in your pancreas called insulinoma.
  • are allergic to glucagon, or any other ingredients in BAQSIMI. See the end of this Patient Information for a complete list of ingredients in BAQSIMI.
Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:
  • have a tumor in your pancreas.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your healthcare provider should decide if you can use BAQSIMI while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use BAQSIMI?
  • Read the detailed Instructions for Use that comes with BAQSIMI.
  • Use BAQSIMI exactly how your healthcare provider tells you to use it.
  • Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
  • Your healthcare provider will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only 1 dose of medicine and cannot be reused.
  • BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.
  • After giving BAQSIMI, the caregiver should call for emergency medical help right away.
  • If the person does not respond after 15 minutes, another dose may be given, if available.
  • Tell your healthcare provider each time you use BAQSIMI.
What are the possible side effects of BAQSIMI?
BAQSIMI may cause serious side effects, including:
  • High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.
  • Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.
  • Serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including:
  • rash
  • difficulty breathing
  • low blood pressure
The most common side effects of BAQSIMI include:
  • nausea
  • vomiting
  • headache
  • runny nose
  • discomfort in your nose
  • stuffy nose
  • redness in your eyes
  • itchy nose, throat and eyes
  • watery eyes
These are not all the possible side effects of BAQSIMI. For more information, ask your healthcare provider.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store BAQSIMI?
  • Store BAQSIMI at temperatures up to 86ºF (30ºC).
  • Keep BAQSIMI in the shrink wrapped tube until you are ready to use it.
Keep BAQSIMI and all medicines out of the reach of children.
General Information about the safe and effective use of BAQSIMI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about BAQSIMI that is written for healthcare professionals.
What are the ingredients in BAQSIMI?
Active Ingredient: glucagon
Inactive Ingredients: betadex and dodecylphosphocholine
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
www.baqsimi.com
Copyright © 2019, Eli Lilly and Company. All rights reserved.
For more information, call 1-800-LillyRx (1-800-545-5979) or go to the following website: www.baqsimi.com.

BAQ-0001-PPI-20190724

INSTRUCTIONS FOR USE

BAQSIMI™

(glucagon) nasal powder

3 mg

Read the Instructions for Use for BAQSIMI before using it. BAQSIMI is used to treat very low blood sugar (severe hypoglycemia) that may cause you to need help from others. 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.

Tube and Device Parts
baqsimi ifu 1 v1.jpg

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.
  • Do not push the plunger or test BAQSIMI before you are ready to use it.
  • BAQSIMI contains 1 dose of glucagon nasal powder and cannot be reused.
  • BAQSIMI is for nasal (nose) use only.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.

Preparing the Dose

baqsimi ifu 2 v1.jpg
  • Remove the Shrink Wrap by pulling on red stripe.
baqsimi ifu 3 v1.jpg
  • 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 ifu 4 v1.jpg

  • Hold Device between fingers and thumb.
  • Do not push Plunger yet.

baqsimi ifu 5 v1.jpg

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

baqsimi ifu 6 v1.jpg

  • 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.

Storage and Handling

  • Do not remove the Shrink Wrap or open the Tube until you are ready to use it.
  • Store BAQSIMI in the shrink wrapped Tube at temperatures up to 86º F (30ºC ).
  • Replace BAQSIMI before the expiration date printed on the Tube or carton.
baqsimi ifu 7 v1.jpg

Other Information

  • Caution: Replace the used BAQSIMI right away so you will have a new BAQSIMI in case you need it.
  • Keep BAQSIMI and all medicines out of the reach of children.

For Questions or More Information about BAQSIMI

  • Call your healthcare provider
  • Call Lilly at 1-800-Lilly-Rx (1-800-545-5979)
  • Visit www.baqsimi.com

BAQSIMI is a trademark of Eli Lilly and Company.

Marketed by: Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2019, Eli Lilly and Company. All rights reserved.

BAQSIMI Device meets all applicable requirements defined in ISO 20072

This Instructions for Use has been approved by the U.S. Food and Drug Adminstration
Issued: July 2019
BAQ-0001-IFU-20190724

logo.jpg

Package Label – Baqsimi 3 Mg Nasal Powder Two Pack

NDC 0002-6145-27

baqsimiTM

(glucagon) nasal powder

3 mg

For Treatment of Severe Low Blood Sugar

For Nasal Use Only

Contains 2 nasal devices.

Keep tubes sealed until ready to use.

Rx only

BAQSIMI Two PackTM

www.baqsimi.com

Lilly

baqsimi carton 006 00.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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