Nasal Glucagon Approved – Time to Breathe a Sigh of Relief

The FDA just approved Baqsimi, a nasal glucagon powder to treat severe hypoglycemia in people with diabetes ages four and older. This first non-injectable form of glucagon should be available by the end of August. The U.S. list price for a Baqsimi one-pack is $280.80 and for a two-pack is $561.60.* This priceing is comparable to injected glucagon.

For people with diabetes and their loved ones, witnessing and treating severe hypoglycemia is scary. This new nasal treatment offers a fast and effective intervention for people at risk for severe hypoglycemia.

“This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”

said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of Baqsimi was evaluated in three studies; two with adults and one with pediatrics over the age of four with type 1 diabetes. The participant’s glucose levels increased sufficiently after the powdered glucagon was nasally administered.

Baqsimi comes in a single-use dispenser and does not need to be inhaled, which means it can be effectively administered to a person who is unconscious due to severe hypoglycemia.

Precautions
Baqsimi is not indicated in people with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas.
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. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms, such as watery eyes and nasal congestion, because of the way the drug is administered.

*Eligible commercially insured people with diabetes can pay $25 for up to two BAQSIMI devices (1 two-pack or 2 one-packs) with a savings card. This prescription is generally filled on an annual basis.  Lilly may also be able to help people who don’t have commercial insurance coverage. Interested persons and healthcare professionals with questions about BAQSIMI can visit www.BAQSIMI.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

More info on Baqsimi approval at FDA Website – Click here


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