For Consumers

Adult Patients

Designed to be simple in a severe hypoglycemia rescue

Needle-free BAQSIMI features1:

  • No injection needed: The first and only dry nasal powder form of glucagon
  • Easy to administer: Absorbed passively in the nose
  • Temperature-stable portability: Can be carried in hot or cold conditions, and stored at up to 86°F (30°C)
  • For any weight, ages 1 year and older: Single, fixed, 3 mg dose
  • Ready to use: No reconstitution or priming

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.1,3

INDICATION

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 1 year and above.

SELECT IMPORTANT SAFETY INFORMATION

Contraindications

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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:

References:

  1. Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
  2. 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).
  3. Data on File, Amphastar Pharmaceuticals, Inc..
  4. Baqsimi. Instructions For Use. Amphastar Pharmaceuticals, Inc..

Safety Summary

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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.

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.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction.

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

Adverse Reactions

Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. BAQSIMI may increase the anticoagulant effect of warfarin.

Please see Full Prescribing Information including Patient Information provided. Please see Instructions for Use included with the device.

Indication

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 1 year and above.

BAQSIMI is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and prior hypersensitivity reaction 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.

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.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction.

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

Adverse Reactions

Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, and itchy nose, throat and eyes.

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
  • Hypoglycemia in Patients with Insulinoma
  • Serious Hypersensitivity Reactions
  • Lack of Efficacy in Patients with Decreased Hepatic Glycogen

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. BAQSIMI may increase the anticoagulant effect of warfarin.

Please see Full Prescribing Information including Patient Information provided. Please see Instructions for Use included with the device.

Indication

BAQSIMI® is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 1 year and above.

Baqsimi
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