Baqsimi (Page 4 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, white powder.
- BAQSIMI One Pack™ carton contains 1 intranasal device (NDC 0002-6145-11)
- BAQSIMI Two Pack™ carton contains 2 intranasal devices (NDC 0002-6145-27)
- Store at temperatures up to 86°F (30°C) in the shrink wrapped tube provided.
- Keep BAQSIMI in the shrink wrapped tube until ready to use. If the tube has been opened, BAQSIMI may have been exposed to moisture and may not work as expected.
- Discard BAQSIMI and tube after use.
17 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:
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Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:
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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?
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What are the possible side effects of BAQSIMI? BAQSIMI may cause serious side effects, including:
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The most common side effects of BAQSIMI include: | ||
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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?
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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: glucagonInactive 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 |
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
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Giving the Dose
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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.
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 2019BAQ-0001-IFU-20190724
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