For Healthcare Providers

Pediatric Patients

Designed to be simple in a severe hypoglycemia rescue

Product features1:

  • Dry nasal powder form of glucagon
  • No inhalation required—absorbed passively in the nose
  • Single, fixed, 3 mg dose
  • Ready to use with no reconstitution or priming
  • Does not need to be refrigerated, store at temperatures up to 86°F (30°C) in the shrink-wrapped tube provided

BAQSIMI can be used for 2 years from the date of manufacture. Instruct patients to check the expiration date on the BAQSIMI tube and carton before use.1,4

Contraindications

BAQSIMI is contraindicated in patients with pheochromocytoma because of risk of substantial increase in blood pressure , insulinoma because of risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

In a severe hypoglycemia emergency, BAQSIMI offers:

1. 100% of pediatric patients achieved treatment success with BAQSIMI 1,*

Treatment success† for BAQSIMI and glucagon for injection

Show Description

This bar graph shows measures of treatment success for BAQSIMI (3 milligrams) and for glucagon for injection (1 milligram) in a study of pediatric patients. One hundred percent of pediatric patients treated with BAQSIMI and 100 percent of pediatric patients treated with glucagon for injection achieved treatment success as defined in the study.

*The mean nadir blood glucose across different age cohorts was 67-73 mg/dL for BAQSIMI and 69-72 mg/dL for glucagon for injection.2

†Treatment success was defined as an increase in plasma glucose of ≥20 mg/dL from the nadir glucose concentration within 30 minutes of glucagon dosing.

Study Design

  • A randomized, multicenter study that evaluated the PK/PD, safety, and efficacy of BAQSIMI compared with glucagon for injection in children and adolescents aged 4 to <17 years with type 1 diabetes (n=48) divided into 3 cohorts.2
  • Young children (ages 4 to <8 years, n=18) and children (ages 8 to <12 years, n=18) were randomized 2:1 to receive either BAQSIMI 2 mg or 3 mg at visit 1 and the alternative BAQSIMI dose at visit 2, or weight-based glucagon for injection at a single study visit. Adolescents (ages 12 to <17, n=12) were randomized 1:1 to receive BAQSIMI 3 mg or glucagon for injection 1 mg with crossover to alternate glucagon at dosing visit 2. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL.2
Learn more about the clinical trials

SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

2. Portable dry nasal spray glucagon

Be prepared with BAQSIMI. The first and only dry nasal spray to treat low blood sugar emergencies

BAQSIMI offers temperature-stable portability.

Patients can carry it with them throughout the day, in hot or cold conditions, and store at up to 86°F (30°C).

BAQSIMI can be taken with you, even in freezing temperatures.

In a study, BAQSIMI was exposed to freezing temperatures as low as -4°F (-20°C) with no adverse effects to the physical, chemical, or performance characteristics of the product.

BAQSIMI can be stored for two years from date of manufacture in the shrink-wrapped tube provided, at temperatures up to 86°F (30°C). Always check the expiration date on the BAQSIMI tube and carton before use.1,4

3. Simplicity of nasal administration

Before BAQSIMI is needed:

  • Read the Instructions for Use for BAQSIMI before using it.
  • 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.

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.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.

Preparing the dose:

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.

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 in 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 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

Discover the simplicity of nasal administration with BAQSIMI

Continue to Pediatric Clinical Trials

References:

  1. Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
  2. Sherr JL, Ruedy KJ, Foster NC, et al. Glucagon nasal powder: a promising alternative to intramuscular glucagon in youth with type 1 diabetes. Diabetes Care. 2016;39(4):555-562.
  3. Pack BW, Melnick J, Breen C, Allen R. Portability of nasal glucagon for the rescue of severe hypoglycemia: stability and performance evaluation across a broad range of temperatures. Diabetes. 2021; 70(suppl 1).
  4. Data on File, Amphastar Pharmaceuticals, Inc.
  5. Baqsimi. Instructions For Use. Amphastar Pharmaceuticals, Inc.

Safety Summary

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in 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 doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

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 doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all 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 doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor 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 doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one 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 doctor each time you use 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.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is 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.

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in 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 doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

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 doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all 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 doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor 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 doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one 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 doctor each time you use 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.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is 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.