First Antidote to Blood Thinner Pradaxa Now Approved

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Praxbind (idarucizumab) was approved on October 16, 2015 as the first drug to reverse the effects of one of the newer blood thinning medications, Pradaxa (dabigatran).

You may be prescribed a blood thinner for various reasons, including blood clot, heart attack, or stroke.

Coumadin (warfarin or Jantoven) is a common “first-line” blood thinner. It’s been around for a long time, and it’s one of the first options your doctor will try. However, there are many newer blood thinners now available, including Pradaxa, Xarelto, and Eliquis.

Why might one of the newer options be better? Warfarin requires regular blood tests to make sure your dose is correct, and comes with dietary restrictions. The newer blood thinners don’t have as many requirements.

The disadvantage of the newer drugs is that their blood thinning effects aren’t easily reversed if you have trouble with bleeding, or need emergency surgery. Warfarin, on the other hand, can easily be reversed in an outpatient setting with oral Vitamin K, also known as Mephyton. You can read more about the differences between the current options here.

What exactly is Praxbind used for?
Praxbind is used to reverse the effects of Pradaxa when needed—for example, if you need emergency surgery or an urgent procedure, or in a life-threatening or uncontrolled bleeding situation.

Is there anything unique about Praxbind?

Yes. Praxbind is the first agent approved specifically for the reversal of Pradaxa (it is not approved to reverse the effects of any of the other blood thinners).

Praxbind was approved faster than usual under the FDA’s accelerated approval program because no other medications existed that could reverse the effects of Pradaxa. It was shown in clinical trials that Praxbind could achieve complete blood thinning reversal of Pradaxa with a single 5-minute infusion and continue working for more than 24 hours.

How is Praxbind used?
Praxbind is given through an IV in 5 gram doses. It is available as a sterile, preservative-free injectable solution and it comes packaged in two single-use 2.5 g/50 mL vials (for a total dose of 5 grams).

When will Praxbind be available?
Praxbind, is expected to become available as quickly as possible, but it will be for hospital use only. You can see this press release from the manufacturer for more information.

Are there side effects associated with Praxbind?

Yes. Praxbind’s side effects can include headache, low potassium, confusion, constipation, fever, and pneumonia.

Still want to find out more about Praxbind?

The FDA announcement has more details here.

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