Indications for: PRAXBIND
Reversal of the anticoagulant effects of dabigatran in emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
The safety and effectiveness of PRAXBIND was investigated in three randomized placebo-controlled healthy volunteer trials, Trials 1321.1, 1321.2 and 1321.5 (NCT01688830, NCT01955720, NCT02028780), and in RE-VERSE AD (RE-VERSal Effects of idarucizumab on Active Dabigatran) trial (NCT02104947), a single cohort case series trial with dabigatran-treated patients who have life-threatening or uncontrolled bleeding, or who require emergency surgery or urgent procedure.
In RE-VERSE AD, 5 grams of idarucizumab was administered to patients treated with dabigatran who presented with dabigatran-related life-threatening or uncontrolled bleeding (Group A) or who required emergency surgery or urgent procedures (Group B). The primary endpoint was the maximum percentage reversal of the pharmacodynamic anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dTT or ECT.
Among evaluable patients, idarucizumab immediately reversed the anticoagulant effect of Pradaxa. Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%), activated partial thromboplastin time (aPTT 93%) or diluted thrombin time (dTT 99%). In addition, there was a low rate of thrombotic events and no new safety events were reported. Findings were similar for Groups A and B.
For IV use only. Administer 5g (2 vials) as 2 consecutive infusions or as bolus injection of both vials consecutively via syringe. Other additional dose: see Warnings/Precautions.
Thromboembolic risk; consider resuming anticoagulant therapy as soon as medically appropriate; can initiate dabigatran 24hrs after Praxbind administration. In patients having a reappearance of bleeding with elevated coagulation parameters or those requiring a second emergency surgery/urgent procedure and have elevated coagulation parameters, consider repeat administration of Praxbind 5g dose. Discontinue immediately if hypersensitivity reactions occur and treat appropriately. Hereditary fructose intolerance. Pregnancy. Nursing mothers.
Humanized monoclonal antibody fragment.
Headache, constipation, nausea; hypersensitivity reactions.
Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4%), an initial half-life of 47 minutes (gCV 11.4%), and a terminal half-life of 10.3 h (gCV 18.9%). After intravenous administration of 5 g idarucizumab, 32.1% (gCV 60.0%) of the dose was recovered in urine within a collection period of 6 hours and less than 1% in the following 18 hours. The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Generic Drug Availability: