Glucagon: FDA Approves New Changes!

Glucagon: dusting off that old rescue kit to see what’s new!

Soon we might have more options for guarding against dangerous lows than the old red and orange boxes!

I always ask a question of new patients that I work with who use insulin “ Do you have a glucagon kit, and who is trained to use it?” All too often the answer is “gluco what?” Glucagon is a life saving rescue for people who use insulin, or a medication that increases their insulin output. Glucagon can save us from life threatening hypoglycemia. A glucagon kit may sit on the shelf unused, but better than needing it and not having it! Get your glucagon prescription from your prescriber every year when you get your insulin and other supply orders renewed. You can get it from your local or mail order pharmacy just like you get your insulin.

Also, check the dates on those kits! They don’t last long. Room temp shelf life is 18 months, refrigerated 36 months. And when you get a new one to replace an expired kit, send us the expired one, we use them to train people on how to save lives!

These kits have not changed much in the last 30 years or so, but they are in for some potentially huge changes. IN the last couple months we have seen two completely new glucagon products submitted for FDA approval.

Xeris Pharmaceuticals has submitted for new drug approval from the FDA following successful stage 3  clinical trials of its ready to use auto injector for glucagon. The G-pen pen works very much like an “Epi-pen”. The user removes the cap and presses the auto-injector to the skin for subcutaneous injection. Usability studies showed that over 99% of users were able to successfully administer the pen with no training. Clinical studies showed 100% efficacy in raising blood sugars above 70mg/dl within 30 minutes. This makes the G-pen as effective as current rescue kits but with a far more usable delivery method.

Lilly also submitted for FDA approval of its inhaled glucagon product. This is a ultra-fine glucagon powder in a ready to use aerator. The small pump is inserted at the nostril and the powder is sprayed into he nose. It can be used even if the victim has nasal congestion or is not breathing. The glucagon is absorbed through the nasal mucosa. Clinical trials showed results on par with other glucagon rescue kits with patients reaching a blood sugar of 70 or higher within 30 minutes.

The most important thing about both of these glucagon rescue systems is the ease of use. Current glucagon kits require that a rescuer inject sterile water into a vial of powdered glucagon, mix the solution, draw it and inject it into the victim. Each of these stems can be done incorrectly.  Far more disconcerting is that persons not specifically trained in glucagon administration are often unable to unwilling to administer this life saving medication, siting: fear of injury to the victim, fear of embolizing the victim by injecting air, fear of being stuck with the needle and inability to use the syringe. Many patients, loved ones, and care givers lack the physical dexterity that might be needed to manipulate the multiple pieces of glucagon rescue kit. Having multiple ready to use two step products is a huge advance in improving safety of people with diabetes.

It is also always a relief to see additional manufacturers enter any area of the diabetes market. To date only Novo Nordisk and Eli Lilly make glucagon rescue kits. The addition of Xeris Pharmaceuticals to the marketplace encourages further innovation and competitive pricing.