MANAGEMENT OF BLEEDING COMPLICATIONS
Should a bleeding complication arise in a patient receiving LIXIANA®, the next LIXIANA® administration should be delayed or treatment should be discontinued as appropriate. LIXIANA® has a half-life of approximately 10 to 14 hours
- Management should be individualised according to the severity and location of the haemorrhage. Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
- For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 iU/kg has been shown to reverse the effects of LIXIANA® 30 minutes after completing the infusion
- Recombinant factor VIIa (r-FVIIa) can also be considered. However, there is limited clinical experience with the use of this product in individuals receiving LIXIANA®
- Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings
- Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of LIXIANA®
- There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving LIXIANA®. There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (desmopressin, aprotinin) in individuals receiving LIXIANA®. Due to the high plasma protein binding LIXIANA® is not expected to be dialysable