Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate. It will not reverse the effects of other anticoagulants (see section 5.1). Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. Praxbind (2 vials of 2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.įor additional instructions for use and handling see section 6.6. Currently available data are described in section 5.1.

The safety and efficacy of Praxbind in children below the age of 18 years have not been established. No dose adjustment is required in patients with hepatic injury (see section 5.2). Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2). No dose adjustment is required in renally impaired patients. No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2). low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.Ībsence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition. Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.Īfter administration of idarucizumab, other antithrombotic therapy (e.g.

Relevant coagulation parameters are activated partial thromboplastin time (aPTT), diluted thrombin time (dTT) or ecarin clotting time (ECT) (see section 5.1).Ī maximum daily dose has not been investigated. patients require a second emergency surgery/urgent procedure and have prolonged clotting times.if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or.recurrence of clinically relevant bleeding together with prolonged clotting times, or.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).Īdministration of a second 5 g dose of idarucizumab may be considered in the following situations: The recommended dose is 5 g idarucizumab (2 vials of 2.5 g/50 mL).

Praxbind prescribing information