Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216, Ingelheim am Rhein, Germany
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:
Restricted to hospital use only.
The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).
Administration of a second 5 g dose of Praxbind may be considered in the following situations:
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
A maximum daily dose has not been investigated.
Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2).
No dose adjustment is required in patients with hepatic injury (see section 5.2).
No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2).
Paediatric population
The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established. No data are available.
Intravenous use.
Praxbind (2x2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
For additional instructions for use and handling see section 6.6.
There is no clinical experience with overdoses of Praxbind.
The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Shelf life: 3 years.
After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light. The solution should not be exposed to light for more than 6 hours (in unopened vial and/or in-use).
For storage conditions after opening of the medicinal product, see section 6.3.
50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
Pack size of 2 vials.
Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.
Praxbind must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of Praxbind. The line must be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
Praxbind is for single-use only and does not contain preservatives (see section 6.3).
No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
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