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BAQSIMI- glucagon powder


  1. Patient Information
  2. Recognition Of Severe Hypoglycemia:
  3. Administration:
  4. Serious Hypersensitivity:
  5. Do Not Use Baqsimi If You:
  6. Baqsimi May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Baqsimi Include:
  8. How Should I Store Baqsimi?
  9. Active Ingredient:
  10. Inactive Ingredients:

Patient Information 

Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient InformationandInstructions 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
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.
    • Read the detailedInstructions for Usethat 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 waybeforeyou need their help.
    • Your healthcare provider will tell you how and when to use BAQSIMI.
    • BAQSIMI contains only 1 dose of medicine andcannotbe 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.

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 orget medical help right awayif 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 86 F (30 C).
  • 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.

Active Ingredient: 

glucagon

Inactive Ingredients: 

betadex and dodecylphosphocholineMarketed 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
Figure

Important Information to Know

  • Do notremove 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 andcannotbe 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

Figure
  • Remove the Shrink Wrap by pulling on red stripe.
Figure
  • 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

Figure

  • Hold Devicebetween fingers and thumb.
  • Do notpush Plunger yet.

Figure

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

Figure

  • Push Plungerfirmly 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 86 F (30 C ).
  • Replace BAQSIMI before the expiration date printed on the Tube or carton.
Figure

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

Figure



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