In July, FDA approved glucagon nasal powder (Baqsimi—Eli Lilly), the first glucagon therapy that can be administered without an injection for emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older. The agent comes in a single-use dispenser containing one dose of glucagon 3 mg, which is administered into one nostril. Because inhalation is not required, the drug can be successfully administered by another person if the receiver is unconscious. “[U]ntil now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process,” noted Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “This new way to administer glucagon may simplify the process, which can be critical during an episode [of severe hypoglycemia], especially since the patient may have lost consciousness or may be having a seizure.” Injectable glucagon has been approved for use in the United States for several decades. Efficacy and safety of glucagon nasal powder to treat severe hypoglycemia was evaluated in two studies of 83 and 70 adults with diabetes. The studies compared a single 3-mg dose of glucagon nasal powder to a single 1-mg dose of I.M. glucagon injection in causing a blood glucose response to insulin-induced hypoglycemia. Glucagon nasal powder 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. In addition, a Phase I study determined that absorption of glucagon nasal powder was not impaired by nasal congestion resulting from the common cold with or without the use of decongestants. Counsel patients and their family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia. Tell them to administer a dose of glucagon nasal power by inserting the device tip into one nostril and pressing the plunger all the way in until the green line is no longer showing. Explain that the medication does not need to be inhaled and will work even if the receiver has a cold or is using cold medication. Family members or caregivers should call emergency assistance immediately after administering the dose. If there has been no response after 15 minutes, an additional 3-mg dose may be administered while waiting for emergency assistance. Be sure to explain that each device contains one dose of glucagon and cannot be reused, so they must use a new dispenser if an additional dose is required. When the receiver responds to treatment, the family member or caregiver should provide oral carbohydrates. Glucagon nasal powder (Baqsimi)Manufacturer: Eli LillyDrug class: AntihypoglycemicIndication: Emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and olderDosage: 3 mg administered as one actuation of the I.N. device into one nostrilOf note: The agent 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). Manufacturer: Eli Lilly Drug class: Antihypoglycemic Indication: Emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older Dosage: 3 mg administered as one actuation of the I.N. device into one nostril Of note: The agent 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). Explain that the most common adverse reactions associated with glucagon nasal powder are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Adverse effects 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. Inform patients and their family members or caregivers that allergic reactions can occur and to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. The agent 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. Patients who are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed should discuss use with their doctor. Inform patients that it is not known if the agent passes into breast milk.