The recommended dose of PRAXBIND is 5 g (2 x 2.5 g/50 ml).
PRAXBIND (2x2.5 g/50 ml) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
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 Pharmacology under Actions).
Administration of a second 5 g dose of PRAXBIND may be considered in the following situations: recurrence of clinically relevant bleeding together with prolonged clotting times, 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.
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see Pharmacology under Actions).
A maximum daily dose has not been investigated.
Instructions for use/ handling: Parenteral drug products 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 sterile sodium chloride 9 mg/ml (0.9 %) solution prior to and at the end of infusion. No other infusion should be administered parallel via the same intravenous access.
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. Once solution has been removed from the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature. The solution should not be exposed to light for more than 6 hours.
PRAXBIND is for single-use only and does not contain preservatives.
No incompatibilities between PRAXBIND and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Traceability: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Restarting Antithrombotic Therapy: PRADAXA (dabigatran etexilate) treatment can be initiated 24 hours after administration of PRAXBIND, if the patient is clinically stable and adequate hemostasis 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 hemostasis has been achieved.
Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Patients with renal impairment: No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab (see Pharmacology: Pharmacokinetics under Actions).
Patients with hepatic impairment: An impact of hepatic impairment, assessed by hepatic injury as determined by elevated liver function tests, on the pharmacokinetics of idarucizumab has not been observed. No dose adjustment is required in patients with hepatic injury (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is required in elderly patients aged 65 years and above (see Pharmacology: Pharmacokinetics under Actions).
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.