Xeris Pharmaceuticals announced this week that the company has filed an NDA (new drug application) to the FDA for its Glucagon Rescue Pen. If and when the pen is approved, it will be the first ready-to-use autoinjector of life saving glucagon to treat severe low blood sugar (hypoglycemia).
The Glucagon Rescue Pen is stable at room temperature and can be administered without any preparation or reconstitution of ingredients. These improvements in ease of use make this life-saving tool more easily administered by a range of people with minimal training.
Current glucagon formulations require the user to mix a liquid and powder in a syringe before injection. Read more about the process and make sure you’re prepared to administer glucagon here.
When it initially began clinical testing several years ago, the Xeris G-Pen was immediately dubbed the next big thing in glucagon treatment. And rightfully so. Both patients and the market have long been awaiting a quick and easy glucagon applicator to treat hypoglycemia and hypoglycemic episodes.
The Chicago-based company recently reported clinical trial data from two phase 3 studies at the American Diabetes Association’s (ADA) Scientific Sessions earlier this summer. Now, the G-Pen is nearing FDA approval and widespread market availability.
If it only allows you to inject the entire pen though, instead of picking a certain amount of units, then for me I would want to put it into an empty vial so I can take what I want. Sterile empty vials are cheap and easy to get.
I never need the full 100 units in a standard glucagon kit. Even if I am out cold, 50 units brings me back very quickly. My wife knows the drill.
My understanding is that this company is working on three methods of administering their glucagon. The first (this one) is designed like an epi-pen. So single dose, simple injection process, designed so anyone can do it, potentially even the person experiencing the severe low. The other is a “mini-dose” pen that allows a variable dose to be dialed in, just like an insulin pen. And the third is designed to be used in a pump cartridge.
I’m super excited for this autoinjetor. I hope that they are seeking Health Canada approval. If not, this is one product I would actually go see a doctor down in the US (or bring my own prescription, if that would be accepted) to acquire before it gets to Canada.
Yeah, but we got Lantus, OmniPod, Dexcom, Minimed 670G years after you guys. We’re still waiting on Symlin and Afrezza and I wouldn’t be surprised if they never come…
I just checked and there is nothing in the Health Canada database of submissions. Hopefully soon!! I have been waiting for this for years already!
Ha, ha. Maybe I’m a little too excited. But I live alone and I travel for work a lot. Both cases in which no one around me would know how to use the traditional glucagon kits if I went low. Heck, I don’t even know if my parents remember how to use it when I stay at their place a couple times a year.
So I feel like this is something a friend, neighbour, or colleague would be able to use without much trouble, even with no training. Or something that I may be able to use on myself if I’m on the verge of passing out (which seems to happen about once a year or so).
I live close to the border, so I’m sure it would be easy for me to drive across, visit a doctor, and get a prescription. Although I’m nervous about what such a thing might cost. I’m not sure if my own endocrinologist could write a prescription that I could fill. I know people who used to drive across the border to get Lantus years before it was available here, but I don’t know how it worked in terms of who prescribed it.
It’s gotta be something that does not look like an insulin pen.
That would be my one concern with anyone injecting me with something, that they don’t give me insulin by mistake. I hope they design it in such a way that it is unmistakable.
Well, I don’t think it will be very difficult re-purpose the emergency supply into mini-glucs. If you only use 15 units per dose, the 100 units would provide 6+ low-BG corrections. I would try to get two kits to start.
The mini-dose pen will be ideal. I wonder how the insurance syndicate will handle this new application for an older medication.
I don’t think it would be easy to re-purpose. Keep in mind it’s in an autoinjector format, like an epi-pen. So it has mechanical parts inside, including a needle that is triggered by pressing on the end of the autoinjector. I suppose if you wanted to try taking it apart you could risk triggering the needle into your thumb (and subsequently injecting all the glucagon into your thumb, since triggering the needle triggers delivery of the medication). Not a risk I’d take, though. I’d stick with the current kits for mini-dosing, or else wait until the company comes out with their pen versions (which I have seen trials for, so it can’t be too far behind).
To an untrained eye, I’m guessing they would look similar. However, I solve this issue by keeping my emergency supplies in a separate location in my bag in a bright red case that I tell people about. I have my insulin and other non-emergency supplies in another kit in my bag that only I access. Plus, to use the mini-dose version I’m pretty sure a needle has to be screwed onto the end and you have to dial up a dose… It would be pretty clear that it’s not the autoinjector.
An autoinjector is usually just a two-step process: pull off cap or safety (or both), push against thigh. That’s it. The needle is already attached and comes out automatically, the medication is pre-measured and injects automatically (there is no plunger to push down), and the needle is even sometimes automatically covered when the device is used. The person using it really doesn’t have to know anything except be able to follow two- or three-step directions printed on the side.
Before anyone gets to giddy over the prospect of this, you might want to wait to see how stupid-expensive it will be. Even with insurance, Glucagon on the market currently, in the US, is super expensive for all but the well-heeled.
How much is it? In Canada it’s around $100, about the same price as an epi-pen. I’d expect the new version to be about the same (well, if/when it comes here). I didn’t realize glucagon had also gone up so much in price.
Cash price at US pharmacies is $250-$300 for a standard Glucagon kit. Yes like a lot of things it has skyrocketing in price. The “30-day supply” in the quote below is of course a misnomer. I’ve had many glucagon kits over the years but all expired before they ever got used. The only time I ever had glucagon it was the EMT’s kit - my last kit I had myself expired probably 5 years ago.
BTW - I remember when the Glucagon kit came in a WOODEN box. I think it was the early 1980’s last time I had that box. If anyone can find a picture of one of these old kits I would love it!
Too bad for me that my Medicare and UHC doesn’t cover it that well.
I’ve spent hundreds of dollars “just in case”, and haven’t used the many kits I’ve bought, going all the way back to the 1980’s. Once I went on a pump in 1996 I for sure haven’t used any Glucagon. I forgot exactly what year prior to that, was my last use of Glucagon. IIRC, I used it either 3 or 4 times. Back then it wasn’t too pricey, either. Despite my not having used it in decades, we always keep it on hand on the off-chance of a severe low.
Have you not had any severe lows during all that time? If so, that is really impressive! I have at least one low a year where I’m close to passing out. The last one happened about six months ago downtown. A stranger approached me to ask if I needed help (which I declined), because even after treating I was stumbling around unable to see and hardly able to walk. If I had a glucagon autoinjector, I totally would have stabbed myself in the leg in a situation like that.
I’ve had maybe 30 glucagon kits in the past 35 years as a diabetic. All expired before I ever used them. I really don’t think my relatives would ever think of using them on me either. Maybe just maybe I could get my wife to check my bg - I taught her once but that was a long time ago.
I’ve had several ER trips and one ambulance call for hypos. Most they’ve given me a glucose or dextrose drip rather than glucagon. The one time they gave me glucagon I discovered that I am EXTRA SUPER NAUSEOUS for a whole day after glucagon. Obviously I’m glad that it saved my life but full-dose glucagon is not something I’d like to undergo regularly.
Perhaps I’m over confident that I could access the glucagon in an emergency kit styled like an epi-pen injector. I have not seen one of those. I’ll need to look at it, of course.
Some of my confidence comes from the recent discovery the G6 restart options by our community. I think at least four methods were documented within the first few weeks. And none of them involved modifying or breaking any parts.
This could be one workaround.
We’ll see what it looks like when it becomes available. I think the largest consideration will be what it costs me out of pocket. If my cost is too high, then using mini-glucs for garden variety lows will be uneconomical. Waiting for the second iteration packaged like an insulin pen may be what will work for me. Time will tell.
I am happy that this product is emerging on the scene. It will help many people, especially rescuers who get confused with the current mixing process when they’re under the stress of the moment.
Yes, the biggest thing is if it really is now possible to make it shelf-stable. We don’t really know much about how it will work until we see it, but definitely a step in the right direction and opening up new avenues for treatment.
I know some people are afraid of glucagon, but I always say it is the forgotten half of the pancreas. It is perfectly natural, and every single non-diabetic in the world “takes” both glucagon and insulin, so why shouldn’t we?
I’m not sure if my own endocrinologist could write a prescription that I could fill. I know people who used to drive across the border to get Lantus years before it was available here, but I don’t know how it worked in terms of who prescribed it.
