BAQSIMI

AbsorptionGlucagon absorption via the intranasal route, achieved mean peak plasma levels of 6130 pg/mL at around 15 minutes.

DistributionThe apparent volume of distribution was approximately 885 L.

EliminationThe median half-life was approximately 35 minutes.

MetabolismGlucagon is known to be degraded in the liver, kidneys, and plasma. Specific Populations Pediatrics In pediatric patients (aged 1 to less than 17 years), glucagon via the intranasal route, achieved mean peak plasma levels betw...

14.1 Adult Patients with Type 1 or Type 2 Diabetes Mellitus Study 1 ( NCT03339453 ) was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with type 1 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mg dose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to <60 mg/dL. Seventy patients were enrolled, with a mean age of 41.7 years and a mean diabetes duration of 20.1 years. Twenty-seven (39%) were female. The primary efficacy outcome measure was the proportion of patients achieving treatment success, wh...

The following clinically significant adverse reactions are described elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . Lack of Efficacy in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] . Most common (≥10%) adverse reactio...

BAQSIMI is contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions ( 5.1 )] Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include ana...

Substantial Increase in Blood Pressure in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because BAQSIMI may stimulate the release of catecholamines from the tumor. ( 5.1 ) Hypoglycemia in Patients with Insulinoma : In patients with insulinoma, administration may produce an initial increase in blood glucose; however, BAQSIMI may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after...

7 DRUG INTERACTIONS Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin : In patients taking indomethacin BAQSIMI may lose its ability to raise glucose or may produce hypoglycemia. ( 7.2 ) Warfarin : BAQSIMI may increase the anticoagulant effect of warfarin. ( 7.3 ) 7.1 Beta-blockers Patients taking beta-blockers may have a ...