Restricted to hospital use only.
Posology: 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 Pharmacology: Pharmacodynamics 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: Pharmacodynamics under Actions).
A maximum daily dose has not been investigated.
Restarting Antithrombotic Therapy: 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.
Patients with renal impairment: No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab.
Patients with hepatic impairment: No dose adjustment is required in hepatically impaired patients (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.
Method of Administration: 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 Special precautions for disposal and other handling under Cautions for Usage.