Reversal Agent for Eliquis and Xarelto Receives FDA “Fast-track” Approval

 

This is great news for people with atrial fibrillation (AF) who take the newer anticoagulants Eliquis or Xarelto. According to a recent article in Cardiology News the FDA, in early May 2018, approved Andexxa (Portola Pharmaceuticals), the first reversal agent for the popular newer anticoagulants Eliquis and Xarelto.

I think runners and mountain bikers, correctly, worry about problems with excessive bleeding while on anticoagulants because we are certainly at increased risk of falls or of being hit by a car, and many have hesitated to transition from warfarin (Coumadin) because of the lack of a reliable reversal agent.

Pradaxa (dabigatran) and warfarin both already have reversal available reversal agents.

Andexxa acts as a decoy molecule and essentially binds to the drug preventing it from interacting with clotting factors.

Terrific news, right?

According to drugs.com “In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.” 

But wait – there’s catch!

Andexxa has been approved but as the writing of this blog post (May 23, 2018) it is not yet available. It exists, but you can’t get it!

I called one of the pharmacists at our hospital (Sky Lakes Medical Center) and asked if it was going to be readily available at our hospital – that’s when I discovered that it wasn’t yet being distributed – but she told me that our hospital plans to have it in stock and available for use.

She also said that once Andexxa is actually available our hospital would then develop guidelines for usage of the new drug. These have not yet been declared but she expects that it will be similar for guidelines pertaining to the reversal agents for Pradaxa and warfarin which are 1.) Patients with serious, life threatening bleeding and 2.) Patients who need emergency surgery.

I think that means that people having elective surgery (like a knee replacement) will not be eligible and will have to taper off their anticoagulant and bridge with Lovenox, just like they do now. I imagine that emergency surgery refers to surgery that is necessary to save your life, not necessarily surgeries like fracture repair, where it would be possible to wait a few days.

As far as my personal experience – I take warfarin and don’t intend to change. I had taken Pradaxa for several years and was very happy with it until I had a mini-stroke and a trans-esophageal echocardiogram revealed that I had a blood clot in my left atrium.

The next big question, of course, is how much will Andexxa cost? I have no idea and I can’t find any information about cost – but I’m guessing it will be really expensive. But then again – people who are anti coagulated and have life threatening bleeding or need emergency life-saving surgery can just go ahead and get Andexxa and worry about how to pay for it later.

 

Any comments are appreciated! Thanks for reading.

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6 thoughts on “Reversal Agent for Eliquis and Xarelto Receives FDA “Fast-track” Approval

  1. Thank you so much for this information!

    I read that you switched to warfarin after you had the mini-stroke. Is warfarin a superior anticoagulant? If so, I think I might like to switch to it. How often do you have to go in and have your blood tested?

    With warfarin, if you had a fall and needed surgery for a fracture repair, not an emergency, but an urgency, would they use the reversal agent for warfarin, since it is less expensive? Even though it’s not an emergency if a person falls and needs a hip replacement, or if a person has appendicitis, it is a pain in the rear having to lie in the hospital for a few days prior to surgery. A lot can happen during that time.

    So if warfarin is considered a superior anticoagulant, and the reversal agent is more readily given, I might consider switching to it. I would just need to know how often I would have to go in to get my blood checked. I have a friend that has to go in once a week, and that sounds like a real inconvenience.

    • I couldn’t say that warfarin is better than Eliquis or Pradaxa, or whatever. What I can say is that people metabolize drugs differently, and I think I’m a person who metabolizes more than others. When I used to drink beer, for example, I could always drink much more than others.

      The advantage of Eliquis, Xarelto, and Eliquis is that you don’t have to test; but in a way that’s also a disadvantage. I have no idea how anti-coagulated I actually was with Pradaxa, but I can say I didn’t notice significant increase in bleeding when, for example, I scratched myself or crashed my mountain bike.

      I have my INR tested (a measure of how anti coagulated I am with respect to warfarin) once per month.

      the criteria for using the warfarin reversal agent is what I outlined above – life threatening bleeding or need for emergency surgery. For non-emergency surgery you would discontinue warfarin for five days and bridge with Lovenox injections (a type of heparin) twice per day. The lovenox is short acting so you just skip the injection the morning of the surgery and you are not anti-coagulated. Then you have to restart the warfarin after the surgery and continue the lovenox until the INR is back up to a therapeutic level.

      Also – it is possible to test your INR level at home.A lot of popped do that now.

      My recommendation is that you talk it over with your doctor.

      • Thank you so much for the great explanation. I will talk this over with my cardiologist. I actually have to find a new one. The cardiologist I’ve had for the past several years is moving. So when I have a new patient appointment, this is going to be at the top of my list.

        I’m wondering what surgeons consider urgent surgery. If someone falls and breaks a hip, it’s not an emergency but I’ve known people who had her lie in the hospital for many days waiting for the anticoagulant to wear off and it’s painful and you get weaker and weaker.

        This is the reason I really hate being on an anti-coagulant. Another friend had appendicitis it wasn’t about to burst so they kept him in the hospital for five days before operating. If he hadn’t been it, he could have been home the same day.

  2. Most surgeries aren’t emergency surgeries – think gunshot wound or auto wreck with excess bleeding. Surgeons and patients alike are frustrated about people having to lie in bed for five days waiting to get their femur fracture repaired. Not taking anticoagulants, remember, really increases your likelihood of having a stroke – and that’s much worse than waiting five days to get yr leg fixed.

    • Yes, intellectually I know that. But I still hate being on this anticoagulant. Especially since it’s been years since I’ve been in sustained atrial fibrillation. I guess I assumed once the reversal agent became available, it would be used for any urgent surgery such as fracturing your femur. I would be glad to pay for it out of my own pocket. If I were ever in that situation.

  3. I was diagnosed with A-Fib 2 years ago about 2 years after I got back into competitive ultra running and obstacle course racing. After a multiple day episode my A-Fib seemed to have gone away on its own, even after high mileage and hard training. In November of 2017 I injured my knee which kept me out of training until April. I have been back training the past two months and just recently had another multi day episode of A-Fib. I am 39 years old and have resisted going on medication but have noticed may spikes in my HR during training the past month that probably led to me staying in AF. As someone who races at a high level, I’m not ready to hang up the shoes. I have lots of questions, please reach out via my email if you are willing to discuss.

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