For Healthcare Providers

Pediatric Adverse Reaction

BAQSIMI adverse reactions in pediatric patients

Adverse Reactions (%)

Spontaneous Adverse ReactionsBAQSIMI 3 mg1
(n=36)		Glucagon for injection2
weight-based (n=24)
Vomiting30.6%37.5%
Headache25.0%12.5%
Nausea16.7%33.3%
Upper Respiratory Tract Irritation*16.7%0%

Questionnaire-Solicited Adverse Reactions1,2

Treatment-emergent nasal and ocular symptoms to be aware of were identified using a questionnaire. BAQSIMI included Watery Eyes (47.2%), Nasal Congestion (41.7%), Nasal Itching (27.8%), Runny Nose (25.0%), Sneezing (19.4%), Itchy Eyes (16.7%), Redness of Eyes (13.9%), Itching of Throat (2.8%), and Itching of Ears (2.8%). Glucagon for injection included Nasal Itching (4.2%), Sneezing (4.2%), Itchy Eyes (12.5%), and Itching of Throat (4.2%); Watery Eyes, Nasal Congestion, Runny Nose, Redness of Eyes, and Itching of Ears were not reported.†

*Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing.

†Subjects were asked to report whether they have the symptom after glucagon administration. The frequency was based on severity increased over baseline.

SELECT IMPORTANT SAFETY INFORMATION

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.

Continue to Using BAQSIMI

References:

  1. Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
  2. Data on File, 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.