HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useBAQSIMI safely and effectively. See full prescribing informationfor BAQSIMI.
BAQSIMI(glucagon)nasal powder
Initial U.S. Approval: 1960
INDICATIONS AND USAGE
BAQSIMI™ is an antihypoglycemic agent indicated for the treatment ofsevere hypoglycemia in patients with diabetes ages 4 years andabove. (1)
DOSAGE AND ADMINISTRATION
• BAQSIMI is for intranasal use only. (2.1)
• The recommended dose of BAQSIMI is 3 mg administered as oneactuation of the intranasal device into one nostril. (2.2)
• Administer BAQSIMI according to the printed instructions on theshrink-wrapped tube label and the Instructions for Use. (2.1)
• Administer the dose by inserting the tip into one nostril andpressing the device plunger all the way in until the green line is nolonger showing. The dose does not need to be inhaled. (2.1)
• Call for emergency assistance immediately after administering thedose. (2.1)
• When the patient responds to treatment, give oral carbohydrates.(2.1)
• Do not attempt to reuse BAQSIMI. Each BAQSIMI device containsone dose of glucagon and cannot be reused. (2.1)
• If there has been no response after 15 minutes, an additional 3 mgdose may be administered while waiting for emergency assistance.(2.2)
DOSAGE FORMS AND STRENGTHS
Nasal powder: intranasal device containing one dose of glucagon 3 mg(3)
CONTRAINDICATIONS
• Pheochromocytoma (4)
• Insulinoma (4)
• Known hypersensitivity to glucagon or to any of the excipients (4)
WARNINGS AND PRECAUTIONS
• Catecholamine Release in Patients with Pheochromocytoma:
Contraindicated in patients with pheochromocytoma because
BAQSIMI may stimulate the release of catecholamines from thetumor. (4, 5.1)
• Lack of Efficacy in Patients with Insulinoma: In patients withinsulinoma, administration may produce an initial increase in bloodglucose; however, BAQSIMI may stimulate exaggerated insulinrelease from an insulinoma and cause hypoglycemia. If a patientdevelops symptoms of hypoglycemia after a dose of BAQSIMI,give glucose orally or intravenously. (4, 5.2)
• Hypersensitivity and Allergic Reactions: Allergic reactions havebeen reported and include generalized rash, and in some casesanaphylactic shock with breathing difficulties, and hypotension. (4,5.3)
• Lack of Efficacy in Patients with Decreased Hepatic Glycogen:BAQSIMI is effective in treating hypoglycemia only if sufficienthepatic glycogen is present. Patients in states of starvation, withadrenal insufficiency or chronic hypoglycemia may not haveadequate levels of hepatic glycogen for BAQSIMI to be effective.Patients with these conditions should be treated with glucose. (5.4)
ADVERSE REACTIONS
Most common (≥10%) adverse reactions associated with BAQSIMI arenausea, vomiting, headache, upper respiratory tract irritation (i.e.,rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis),watery eyes, redness of eyes, itchy nose, throat and eyes. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lillyand Company at 1-800-LillyRx (1-800-545-5979) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Beta-blockers: Patients taking beta-blockers may have a transientincrease in pulse and blood pressure. (7.1