Bleeding Management of Xarelto®

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

Managing Bleeding on Xarelto, Recommended strategies for the management of bleeding eventsManaging Bleeding on Xarelto, Recommended strategies for the management of bleeding events

FFP FFP
Fresh frozen plasma (= FFP). The fluid portion of human blood that has been put in a machine known as centrifuge, then separated and frozen solid.
, fresh frozen plasma; PCC PCC
Prothrombin complex concentrate (= PCC). This is a human clotting factor complex derived from human plasma. PCC is used to reverse the effects of oral anticoagulation if major bleeding occurs or urgent surgery is required.
, prothrombin prothrombin
Inactive version of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots. Factor Xa stimulates the conversion of prothrombin to thrombin.
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 VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
-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.