Medication Monitor

Generic Name (Trade Name—Company)
July 30, 2019

Glucagon nasal powder

(Baqsimi—Eli Lilly)
FDA approves glucagon nasal powder for severe hypoglycemia

FDA approved Baqsimi nasal powder, the first glucagon therapy that can be administered without an injection for emergency treatment of severe hypoglycemia. It is indicated for patients with diabetes aged 4 years and older. The agent will come in a single-use dispenser.

Injectable glucagon has been approved for use in the United States for several decades. Efficacy and safety of Baqsimi nasal powder to treat severe hypoglycemia was evaluated in two studies of 83 and 70 adults with diabetes, comparing a single dose of Baqsimi to a single dose of glucagon injection in causing a blood glucose response to insulin-induced hypoglycemia. Baqsimi adequately increased blood glucose levels. Similar results were observed in a pediatric study of 48 patients with type 1 diabetes who were older than 4 years.

Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas. The agent should not be taken by patients with a known hypersensitivity to glucagon or the inactive ingredients found in Baqsimi, as allergic reactions may occur. Baqsimi also carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia, because these conditions result in low levels of releasable glucose in the liver.

The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Adverse effects of Baqsimi are similar to those of injectable glucagon, with the addition of nasal and eye-related symptoms (e.g., watery eyes and nasal congestion) because of the way the drug is administered.