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Pediatric Clinical Trials

Following insulin-induced glucose reduction, 100% of patients achieved treatment success with BAQSIMI1,*

Treatment Success† for BAQSIMI and glucagon for injection

*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
  • Study I8R-MC-IGBO; An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients with Type 1 Diabetes Aged 1 to <4 years.2

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.

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.

Mean plasma glucose concentrations over time with BAQSIMI2

Mean Glucose Concentration Over Time With BAQSIMI 3 mg in Ages 4 to <17 Years Old

Compare BAQSIMI to glucagon for injection for cohorts

Mean Time to Treatment Success (minutes)

Age GroupBAQSIMI 3mg n=12IMG* n=6
Young Children (4 to <8 years old)10.810.8
Children (8 to <12 years old)11.312.5
Age GroupBAQSIMI 3mg n=12IMG* n=12
Adolescents (12 to <17 years old)14.212.5

*0.5 mg or 1 mg of IMG (based upon body weight)

Study Design2

  • 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.
  • 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 years, 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.
  • 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.

Common cold with nasal congestion did not impact absorption of BAQSIMI3

Glucose Concentrations Over Time Following BAQSIMI Administration

Study Design3

  • A randomized, single-center, open-label, repeated-measures, parallel-design, phase I study examining the safety and PK/PD of a single BAQSIMI 3 mg dose in otherwise healthy adult participants with nasal congestion resulting from common cold.
  • Adult participants in cohort 1 (n=18) received 2 doses of BAQSIMI 3 mg: one while experiencing nasal congestion and another after recovery from cold symptoms.
  • Adult participants in cohort 2 (n=18), who also had colds with nasal congestion, received a single dose of BAQSIMI 3 mg 2 hours after treatment with the decongestant oxymetazoline.
  • Blood glucagon and glucose concentrations were measured before and at various time intervals until 180 minutes after BAQSIMI administration.

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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