Praxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:
PRAXBIND has been specifically developed to reverse the anticoagulant effects of dabigatran, the active ingredient in PRADAXA® (dabigatran etexilate).1,2
There are serious risks and adverse reactions 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. Please see the Important Safety Information and Adverse Reactions sections below.
*Accurate as of 01/03/20, based on the current information provided to Boehringer Ingelheim Pharmaceuticals, Inc. The company cannot guarantee the availability of PRAXBIND at all facilities in every state.
†Median age was 78 years and median creatinine clearance (CrCl) was 53 mL/min. Approximately 62% of patients in Group A and 62% of patients in Group B had been treated with dabigatran 110 mg BID.
‖Based on determination for dTT or ECT.
¶The time to the cessation of bleeding could not be assessed in the 98 patients with intracranial bleeding, because there is dissociation between the clinical course and the extent of bleeding.
Clinical relevance of findings from
Group A and B is undetermined.
aPTT=activated partial thromboplastin time; ECT=ecarin clotting time; dTT=dilute thrombin time; ULN=upper limit of normal
‡Determined by mean clotting time below the ULN as measured by ECT and aPTT.
§Blood samples were obtained at baseline, after the first infusion, at 10-30 min after the second infusion, and at 1, 2, 4, 12, and 24 hours.4
In the RE-VERSE AD™ (RE-VERSal Effects of idarucizumab on Active Dabigatran) trial, a total of 503 dabigatran-treated patients were administered idarucizumab either because they required an emergency surgery or urgent procedure, or because they presented with life-threatening or uncontrolled bleeding. The adverse reactions reported in ≥5% of patients were constipation (33/503, 7%) and nausea (23/503, 5%).
Of the 503 dabigatran-treated patients in the entire study period, 101 patients died, 19 within the first day after idarucizumab dosing; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
In the RE-VERSE AD trial, 33 of 503 patients reported thrombotic events, 11 patients within 5 days after treatment with idarucizumab and 22 patients 6 days or more after treatment with idarucizumab. Most of these patients were not on antithrombotic therapy at the time of the event, and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient.
Patients being treated with PRADAXA therapy have underlying disease states that predispose them to thromboembolic events. Reversing PRADAXA therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.1
PRADAXA treatment can be re-initiated 24 hours after administration of PRAXBIND.
Pyrexia, bronchospasm, hyperventilation, rash, and pruritus have been reported in clinical trials with idarucizumab.
As with all proteins, there is a potential for immunogenicity with idarucizumab. Treatment-emergent possibly persisting anti-idarucizumab antibodies with low titers were observed in 4% (10/224) of healthy subjects and 2% (8/501) of patients treated with idarucizumab.1
There are serious risks and adverse reactions 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. Please see more complete details of these risks in the Important Safety Information below.