The wait is finally over for an EpiPen-like auto-injector that can boost blood sugars instantly in case of a diabetes emergency.
The much-anticipated Gvoke HypoPen made by Chicago-based Xeris Pharmaceuticals is now available, after a July 2020 launch. This comes within a year of U.S. regulatory clearance for this product that follows a prefilled syringe version launched in 2019.
While the HypoPen is an auto-injector containing a 6mm needle, you’ll never see the needle in action as the pen is self-contained for quick one-time use and disposal.
This form factor is positively revolutionary compared to the traditional emergency glucagon kits — red or orange plastic containers housing a vial of dry glucagon powder and liquid-filled syringe that have to be mixed and administered on the spot. The process is intimidatingly complex, especially in the midst of an emergency trying to revive someone who’s fallen unconscious, and the oversized syringe is quite frightening, to say the least.
Now, the HypoPen brings an easy, ready-to-use device with a simple two-step process: Pull off the red cap and push the pen down on the skin for 5 seconds until the window turns red. That’s it!
The HypoPen is, in fact, the second alternative to traditional rescue glucose to hit the market in the past year. The first was the world’s first nasal spray version, Eli Lilly’s Baqsimi, in August 2019.
While this compact Gvoke HypoPen is the first alternative glucose injection that’s ready to use in emergencies, its potential to be a game-changer in glucagon products is dampened by the current price tag, which will likely make it inaccessible to most people. (More about that later.)
First, here’s my personal experience trying it out, by inducing two hypoglycemic events at home. (NOTE: This was done safely in the presence of my wife’s watchful eye, plus careful tracking with my continuous glucose monitor.)
The HypoPen comes packaged in an easy-to-open protective pouch, which we’re told to keep on the device until the time of use.
In order to test it, I induced a low blood sugar on two occasions by taking extra insulin calculated to bring my blood glucose (BG) levels down to ideally in the 40-50 mg/dL range — safe enough to where I wouldn’t pass out, but low enough to prompt treatment. In the first case, my wife, Suzi, did the injection. In the second case, I did it myself.
It burned for a brief moment after pushing the HypoPen into my skin, but it wasn’t painful and did not leave a mark of any sort on my skin. The experience also didn’t leave me feeling physically or emotionally scarred — as I have felt in the past after someone has had to use a traditional glucagon kit on me during an emergency.
Blood sugar effects
In both cases, I dosed extra insulin to induce my Low but made sure there was no active insulin on board by the time of the HypoPen injection. I watched my CGM diligently to make sure my BG was heading downward, but not too dramatically. I also avoided any food in the 2 hours before and after using the HypoPen, as not to interfere with its BG effect.
Test 1: Even though I was shooting for 40-50, my BG ended up hovering at a “mild low” of 60-70 mg/dL. This was enough of a Low for purposes of my review, as I was starting to feel the symptoms (shivering, shaking). I had my wife use the HypoPen on my upper arm.
Keeping in mind that there’s a built-in lag on CGM readings, I saw my sugars start rising within 7 minutes. Within 10 minutes, I was hitting the 90s.
Twenty minutes later, I was at 114 mg/dL with an up arrow on my CGM.
Just over an hour post-HypoPen, I’d leveled off at around 240 mg/dL and shortly before the 90-minute mark, I started to see a slight dip as the glucagon wore off.
Test 2: The second time around, I got to a much lower “Urgent Low” state of 55 mg/dL with a sideways down arrow (indicating a slow decline).
This time I injected the pen myself, into my upper thigh. In just over 5 minutes, I started seeing a bump in BG levels. I rose much faster this time around, ending up leveling off at close to 300 mg/dL 1.5 hours later before my BGs started dipping a bit as the HypoPen’s glucagon began to wear off.
Overall, I saw a similar trajectory in how the HypoPens raised my BG, boosting me up to “safe” levels within minutes and then raising them quite high over the next 90 minutes.
Usability is certainly the big selling point for the HypoPen, and Xeris recognizes that. In a call with company leadership in mid-2020, their execs cited the statistic that only 31 percent of those with the emergency glucagon kits used them correctly.
Well-known Atlanta-based endocrinologist Dr. Bruce Bode, who’s been involved in promoting Gvoke, says everyone should be trained on using this far-simpler Gvoke pen, if possible.
A full list of advantages of the product include:
- Ready-to-go: HypoPen’s plastic auto-injector is very easy to use. All you have to do is unscrew the red cap and press the yellow part onto your skin for 5 seconds.
- Less panic for others: It’s also exponentially easier for those who’d be likely injecting us with glucagon, compared to the traditional kits. This is by far the biggest selling point for HypoPen. (See my wife’s point of view below).
- No bad side effects: There are no noticeable negative side effects like nausea, as I’ve experienced with traditional glucagon injections. Although personally I did develop a minor headache due to my blood sugars rising so quickly.
- Portability: The pen can be easily carried and kept safe in its protective pouch. Nice, too, that it’s stored at room temp and doesn’t require any refrigeration (which traditional glucagon kits also don’t need, despite common beliefs to the contrary).
- Insurance coverage: My Blue Cross Blue Shield plan unexpectedly covered it with only a small co-pay. That was nice for me, but may not be the case for everyone.
Here are the downsides:
- It’s still an injection: It still uses a needle (even if not seen) versus a more non-invasive treatment method like the nasal inhaler Baqsimi offers. No matter how you slice it, injections can be anxiety-inducing.
- Felt the burn: Both injections caused a slight burn at the injection site after I’d used the HypoPen, and in my thigh, it lasted for a good half hour after using it.
- Red window: Despite the simple operation, we were a bit confused when the little window didn’t turn completely red but only filled partially even after 5 seconds. This raised questions about whether I had received the full amount.
- Temperature: While it doesn’t require refrigeration, the HypoPen does have a heat ceiling of 77 degrees. So it likely would be at risk in a vehicle during the hot summer months or when out hiking in the heat for any duration. You’re also not supposed to freeze it, so extreme winter temps could be an issue too.
- No mini-dosing: Sorry, folks. Not possible. I tried holding the pen plunger for 2 seconds rather than longer, and it still injected what seemed to be the full dosage. Xeris working on a future product that will allow mini-dosing, but that’s likely a couple of years out at least.
- Pricing: Affordability is key, of course, and the HypoPen’s $300 price tag is a show-stopper.
This is what my wife had to say about the usability of this HypoPen:
“Whenever you are giving someone else a shot of anything, it’s unnerving as it’s not something you are used to doing — especially when it’s something that is designed to ‘instantly save their life.’
“With that being said, this Gvoke HypoPen is much easier to use compared to the traditional glucagon kit’s injection. There was no mixing. You can just give the shot and move on. Nor did I have to pinch the skin, as we do on a regular insulin shot. It’s a quick, ready-to-go pen that doesn’t require any preparation.”
Importantly, she added: “If my husband was unconscious or in a state of confusion during a Low blood sugar, of course, I’d be more at ease using and injecting him with this than the traditional glucagon kit!”
For us, this is a huge point given my history of aggressive and sometimes-violent behavior during severe hypoglycemic episodes.
“Having this on hand might stop me from needing to phone the paramedics in advance, out of fear that I wouldn’t be able to prepare the mix and stab him with the needle as quickly as I’d need to,” she shared.
“What I didn’t like about HypoPen is that you don’t necessarily know how much was dispensed, even with the window that turns red after injection. When I used it, the full window only partially turned red — whereas, with the normal glucagon kit and shot, the entire syringe was clear so you could give a partial dose if needed.”
Xeris has envisioned glucagon as a hypoglycemia treatment that can move beyond emergency situations. DiabetesMine attended two of their patient community forums in late 2018 and early 2019 when the conversations were largely focused on changing the perspective of how glucagon is used only as a “break-the-glass” emergency option.
With the Gvoke products, Xeris has marketed the ready-to-go usability and portability along with the fact that these are actual FDA-cleared medical treatments. They’ve pushed for glucagon to be viewed as the go-to trusted treatment versus everyday affordable items like juice boxes, frosting, candy, or whatever else folks might use to raise BGs quickly.
Given the high pricing of this prescription item, and the fact that “everyday candy” is quite easy to use as well, the HypoPen may face an uphill battle gaining customers.
Unfortunately, this new HypoPen will be largely inaccessible to most people with diabetes despite its potential to shift the paradigm on how we use glucagon, beyond just for emergencies.
That’s due to the nearly $300 list price (on par with other existing glucagon products, Xeris says). While I was lucky that my insurance plan did cover it with an affordable co-pay, too many others won’t have equivalent coverage to get their hands on the HypoPen.
The same goes for Lilly’s Baqsimi. A single pack currently costs about $280, making it out of reach for most patients on top of all the other diabetes bills, let’s be honest.
We’re calling upon these Pharma companies to do better for patients. That includes the next-gen glucagon-manufacturer Zealand Pharmaceuticals in Texas, which is developing its own ready-to-use auto-injector that’s currently under review with the FDA.
Let’s hope that cost isn’t an afterthought, and the first move to address it involves offering financial assistance — because you already know it’s not priced for the masses. If you start out that way, you’re creating “concierge” medical products for the privileged right out of the gate.
Mike Hoskins is managing editor of DiabetesMine. He was diagnosed with type 1 diabetes at age 5 in 1984, and his mom was also diagnosed with T1D at the same young age. He’s written for daily, weekly, and specialty news publications before joining DiabetesMine. He lives in Southeast Michigan with his wife, Suzi, and their black lab, Riley.