Symptoms: Overdose following administration of PRADAXA may lead to haemorrhagic complications due to its pharmacodynamic properties. Doses of PRADAXA beyond those recommended expose the patient to increased risk of bleeding.
Therapy: In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
Depending on the clinical situation appropriate standard treatment, e.g. surgical haemostasis as indicated and blood volume replacement, should be undertaken.
For situations when rapid reversal is required the specific reversal agent (PRAXBIND, idarucizumab) antagonising the pharmacodynamics effect of PRADAXA is available (see Surgery and Interventions, Preoperative Phase under Precautions).
In addition, consideration may be given to the use of fresh whole blood or fresh frozen plasma.
Coagulation factor concentrations (activated or non-activated) or recombinant Factor VIIa may be taken into account. There is some experimental evidence to support the role of these agents in reversing the anticoagulant effect of dabigatran but their usefulness in clinical settings has not yet been systematically demonstrated. Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet drugs have been used. All symptomatic treatment has to be given according to the physician's judgement.
As protein binding is low, dabigatran is dialysable, however there is limited clinical experience in using dialysis in this setting (see Pharmacology: Pharmacokinetics: PK in special populations under Actions).