All licenced anticoagulants deliver a positive benefit risk profile. However, all anticoagulants can increase the risk of bleeding.1 Some patients are at greater risk than others. At present there is no approved reversing agent for Xarelto, but familiar, consensus-based bleeding management protocols can be generally applied.1
The following recommendations reflect current published clinical trials, consensus publications, regulatory statements and the growing clinical experience with Xarelto, which now includes treatment of over 39 million patients worldwide, across 7 licensed indications.a,3,4
Recommended strategies for the management of bleeding events2
FFP , fresh frozen plasma; PCC , prothrombin complex concentrate; rFVIIa, recombinant factor VIIa.
General management of acute bleeding1
Individualise according to the severity and location of the haemorrhage.
Delay or discontinue ongoing treatment with Xarelto2,4
Employ symptomatic treatment measures, appropriate to bleed severity:
- Mechanical compression
- Surgical haemostasis with bleeding-control procedures
- Fluid replacement and haemodynamic support
- Blood products (packed red cells and or fresh frozen plasma)
Severe, life-threatening bleed-management recommendations1
PCC as a first choice using the same dose of PCC as recommended for reversal of VKA -induced bleeding (25–50 IU per kg body weight) may be considered.
Activated PCC (FEIBA) and recombinant factor VIIa have also been tested in experimental settings.
Managing overdose of Xarelto2,4
Activated charcoal may be helpful to reduce absorption if used within 2 hours of suspected overdose.
Due to high protein binding, dialysis is ineffective.
If overdose is accompanied by bleeding, the general management methods above should be followed.
Once bleeding has ceased1
Re-assess thrombotic risk and restart Xarelto at the relevant dose when appropriate.
a Calculation based on IQVIA MIDAS Database: Quarterly Sales Q4 2017.