Praxbind Dosage/Direction for Use

Restricted to hospital use only.
The recommended dose of Idarucizumab (Praxbind) is 5 g (2 x 2.5 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.
Administration of a second 5 g dose of Idarucizumab (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).
A maximum daily dose has not been investigated.
Restarting Antithrombotic Therapy: Dabigatran etexilate (Pradaxa) treatment can be re-initiated 24 hours after administration of Idarucizumab (Praxbind), if the patient is clinically stable and adequate haemostasis has been achieved.
After administration of Idarucizumab (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.
Elderly: No dose adjustment is required in elderly patients aged 65 years and above.
Paediatric population: The safety and efficacy of Idarucizumab (Praxbind) in children below the age of 18 years have not yet been established. No data are available.
Method of administration: Intravenous use.
Idarucizumab (Praxbind) (2 x 2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.