Praxbind - The specific reversal agent of Pradaxa
When rapid reversal of the anticoagulant effects of Pradaxa is required, Praxbind offers immediate reversal. Pradaxa is the first non vitamin K antagonist oral anticoagulant (NOAC) with a specific reversal agent. Together, Pradaxa and Praxbind set a new standard in anticoagulation care.
For the rapid reversal of the anticoagulation effects of Pradaxa in:
- Emergency surgery/urgent procedures1,2
- Life-threatening or uncontrolled bleeding1,2
Contra indications and adverse reactions
- There are no contra indications
- No adverse reactions have been identified in clinical studies
Pradaxa with Praxbind provides added confidence and keeps you more in control.
How do I administer Praxbind?
Praxbind is given as 2 separate vials each containing 2.5 g/50 mL in a ready-to-use solution1
The full 5 g dose is administered intravenously as:1
Two consecutive intravenous infusions over 5-10 minutes each
A bolus injection, by 2 injecting both vials consecutively one after another
A pre-existing intravenous line may be used1
- No other infusion should be administered in parallel via the same intravenous access
Other supportive measures can be used alongside Praxbind, including mechanical compression, surgical hemostasis, fluid replacement (colloids if needed), packed red blood cells if needed, fresh frozen plasma (as plasma expander), platelet substitution (if platelet count ≤60 x 109/L).1
How does Praxbind work?
Praxbind specifically binds to Pradaxa to completely reverse the anticoagulation effect.1
Pradaxa is almost completely covered making it unable to interact with thrombin.3
- Praxbind potently and rapidly binds to Pradaxa, with a high affinity (350-fold more potent than the binding affinity of Pradaxa for thrombin).3
- Available data suggest that Praxbind has a low immunogenic potential and can be re-administered (i.e. no antibodies formed against Praxbind).
Praxbind is a humanized monoclonal antibody fragment (Fab).1
Praxbind has no procoagulant or anticoagulant effects.
Has Praxbind been studied?
Yes. REVERSE-ADTM is an ongoing global, Phase III, multicenter, prospective study investigating the effectiveness and safety of Praxbind in patients treated with Pradaxa. The study was designed to reflect potential real-world situations in which patients may require rapid emergency reversal of the anticoagulant effect of Pradaxa e.g. those with life-threatening or uncontrolled bleeding, requiring urgent medical intervention or, who required emergency surgery or intervention.5
The study met its primary endpoint, achieving 100% median maximum reversal of Pradaxa across all patients (95% CI 100 to 100).
- Reversal was evident immediately after administration of the first vial of Praxbind and was complete in all but 1 patient.
- 4 and 12 hours after administration of Praxbind, laboratory tests showed normal coagulation levels in almost 90% of patients.
- Normal blood clotting (hemostasis) during surgery was reported in 92% of patients that required surgery or invasive procedures.
Can I restart treatment with Pradaxa after Praxbind?
Yes. Treatment with Pradaxa can be restarted 24 hours after administration of Praxbind, providing the patient is clinically stable and adequate hemostasis has been achieved. Other antithrombotic therapy (e.g. low-molecular weight heparin) can be given immediately after the administration of Praxbind.1
Can I administer a second 5g dose of Praxbind?
Based on the pharmacokinetic properties of Praxbind and its high specificity in binding to Pradaxa, clinically relevant interactions with other drugs are unlikely however, no formal interaction studies have been performed.
There are no known contraindications with Praxbind.1
Can I prescribe Praxbind in my patients with renal impairment?
The administration of a second 5 g dose may be considered in the following situation
- Recurrence of clinically relevant bleeding together with prolonged clotting time, or
- if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or
- patients require a second emergency surgery/urgent procedure and have prolonged clotting times
Praxbind has a shelf life of 24 months and comes as vials of ready-to-use solution and must be kept refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. Prior to use, the unopened vial may be kept at room temperature 25°C (77°F) for up to 48 hours, if stored in the original package in order to protect from light, or up to 6 hours when exposed to light.
- Once Praxbind has been removed from the vial, administration should begin promptly or within 1 hour
- Parenteral drug products should be inspected visually for particulate matter and abnormal discoloration prior to administration
- If a pre-existing intravenous line is used to administer Praxbind, this must be flushed with sterile sodium chloride 9 mg/ml (0.9%) solution prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access
- Do not mix or co-administer with other medications
- Praxbind is for single-use only, as the product contains no preservatives
- No incompatibilities between Praxbind and polyvinyl chloride, polyethylene, polyurethane or polyolefin infusion sets have been observed
- Praxbind Summary of Product Characteristics 2016. Boehringer Ingelheim.
- Pollack CV Jr et al. N Engl J Med 2015;373(6):511–520.
- Schiele F et al. Blood 2013;121:3554-3562.
- Glund S et al. ASH 2014: abst 334.
- Pollack Jr CV et al. Thromb Haemost 2015;114(1):198-205.