Patient information: uses, side effects, how to take - Baqsimi

What is BAQSIMI?

BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 1 year and above.

It is not known if BAQSIMI is safe and effective in children under 1 year 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.
have had an allergic reaction to glucagon, or any of the ingredients in BAQSIMI. See the end of this Patient Information leaflet for a complete list of ingredients in BAQSIMI.

Talk with your healthcare provider before taking this medicine if you have any of these conditions.

Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:

have adrenal gland problems.
have a tumor in your pancreas.
have not had food or water for a long time (prolonged fasting or starvation).
have low blood sugar that does not go away (chronic hypoglycemia).
are pregnant or plan to become pregnant. It is not known if BAQSIMI will harm your unborn baby.
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 and those around you know where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
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.
Act quickly. Having very low blood sugar for a period of time may be harmful.
After giving BAQSIMI, the caregiver should call for emergency medical help right away.
When you are able to safely swallow food or drink, your caregiver should give you a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
If the person does not respond after 15 minutes, another dose of BAQSIMI from a new device may be given, if available while waiting for emergency services.
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 called insulinomas 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
hives
cough

difficulty breathing
trouble swallowing
swelling of face, lips, or tongue

low blood pressure
feeling dizzy or faint
fast heartbeat

The most common side effects of BAQSIMI include:

nausea
vomiting
headache
runny nose

discomfort in your nose
stuffy nose
cough
nose bleed

watery eyes
redness in your eyes
itchy nose, throat, and 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.
Throw away (discard) BAQSIMI and tube after use. Used BAQSIMI may be placed in household trash.

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 health professionals.

What are the ingredients in BAQSIMI?

Active Ingredient: glucagon

Inactive Ingredients: betadex and dodecylphosphocholine

Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730, U.S.A.

www.baqsimi.com

For more information, call 1-800-423-4136 or go to the following website: www.baqsimi.com.

698351AMD

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 will 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 not 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

	Remove the Shrink Wrap by pulling on red stripe.
	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 into 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 passed out (unconscious) turn the person on their side.
Encourage the person to eat as soon as possible. When they can 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 ).
Throw away (discard) BAQSIMI and Tube after use. Used BAQSIMI may be placed in household trash.
Caution: Replace the used BAQSIMI right away so you will have a new BAQSIMI in case you need it.
Replace BAQSIMI before the expiration date printed on the Tube or carton.

Keep BAQSIMI and all medicines out of the reach of children.

For Questions or More Information about BAQSIMI

Call your healthcare provider
Call Amphastar Pharmaceuticals, Inc. at 1-800-423-4136
Visit www.baqsimi.com

BAQSIMI is a registered trademark of Amphastar Pharmaceuticals, Inc.

Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730, U.S.A

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

Revised: March, 2025

678351AMC/3-25