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BAQSIMI(glucagon)nasal powder(三)
e after 15 minutes, an additional 3 mg dose of BAQSIMI from a new device may beadministered while waiting for emergency assistance.
3 DOSAGE FORMS AND STRENGTHS
Nasal Powder:
3 mg glucagon: as a white powder in an intranasal device containing one dose of glucagon
4 CONTRAINDICATIONS
BAQSIMI is contraindicated in patients with:
Pheochromocytoma [see Warnings and Precautions (5.1)]
Insulinoma [see Warnings and Precautions (5.2)]
Known hypersensitivity to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have beenreported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [seeWarnings and Precautions (5.3)]
5 WARNINGS AND PRECAUTIONS
5.1 Catecholamine Release in Patients with Pheochromocytoma
BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release ofcatecholamines from the tumor [see Contraindications (4)]. If the patient develops a dramatic 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.
5.2 Lack of Efficacy in Patients with Insulinoma
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 exaggeratedinsulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with
insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI,give glucose orally or intravenously.
5.3 Hypersensitivity and Allergic Reactions
Allergic reactions have been reported with glucagon, these include generalized rash, and in some casesanaphylactic shock with breathing difficulties and hypotension. BAQSIMI is contraindicated in patients with a priorhypersensitivity reaction [see Contraindications (4)].
5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen
BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states ofstarvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogenfor BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
• Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3)].
6.1 Clinical Trial Data
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflectthe rates observed in practice.
Adverse Reactions in Adult Patients
Two similarly designed comparator-controlled trials, Study 1 and Study 2, eva luated the safety of a single dose ofBAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes [see ClinicalStudies (14)].
Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and
Study 2.
Table 1: Pooled Adverse Reactions (≥2%) in Adult Patients with Type 1 and Type 2 Diabetes in Study 1 and
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