RIDGEFIELD, Conn. — Boehringer Ingelheim announced that Praxbind (idarucizumab), a specific reversal agent for Pradaxa (dabigatran etexilate mesylate), is now stocked in 3,200 hospitals in all 50 states.
This represents a significant increase in the availability of Praxbind since March 2016, when it was stocked in 2,200 institutions. Healthcare providers and patients can quickly search for institutions in the U.S. where Praxbind is stocked by using a zip code locator tool available at Praxbind.com.
“Emergency situations are unpredictable and access to a reversal agent is important for the rare events when the anticoagulant effect of Pradaxa must be reversed,” said Thomas Seck, vice president, clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We hope patients are reassured in knowing that a specific reversal agent for a NOAC is widely available.”
The U.S. Food and Drug Administration approved Praxbind as a specific reversal agent for Pradaxa in October 2015 under accelerated approval—followed by full approval in April 2018—for use in the event of an urgent procedure/emergency surgery or uncontrollable/life-threatening bleeding.
Praxbind is the first and only specific reversal agent for a novel oral anticoagulant (NOAC), and provides immediate reversal of the anticoagulant effect of Pradaxa. It is highly specific to Pradaxa and offered in a hospital in one, ready-to-administer dose for all Pradaxa patients.
The safety and efficacy of Praxbind in reversing the anticoagulant effect of Pradaxa has been demonstrated through the phase III RE-VERSE AD study, the largest study to investigate a reversal agent for a NOAC. The final results of this study were published in the New England Journal of Medicine in July 2017. Additionally, the ongoing RE-VECTO program evaluates usage patterns of Praxbind in the clinical practice setting.
There are serious risks to consider when treating patients with Praxbind, including warnings and precautions for thromboembolic risk, re-elevation of coagulation parameters, hypersensitivity reactions and risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient. The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (5%). The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).
Praxbind is distributed by U.S. hospital pharmacy distributors ASD, Cardinal Health, MPB, HD Smith and Morris Dickson. Orders can generally be filled or restocked within 24 hours.