Education Blog for Healthcare Professionals

FDA Approval of New Drug to Treat Major Bleeding on Warfarin – Kcentra

Stephan Moll, MD writes…  A new drug for the urgent reversal of warfarin was approved by the FDA today, April 29th, 2013 (announcement by the FDA is here), called Kcentra.  The drug is derived from pooled plasma from healthy blood donors and contains the coagulation factors that are low in warfarin-treated patients, i.e. factors II, VII, IX, and X.  It is also referred to as a 4-factor concentrate, or non-activated Prothrombin Complex Concentrate (PCC).  The drug prescribing information (package insert) is here.

Up until now only 3-factor concentrates (PCC) and fresh frozen plasma (FFP) were available in the U.S. in addition to vitamin K to urgently reverse warfarin and to treat major bleeding in warfarin-treated patients.  The new drug is a welcome addition to the armamentarium when having to treat warfarin-associated major bleeding.  Where until now I used to give 3-factor PCCs, I will now give the 4-factor PCC.

 

Bleeding and the new oral anticoagulants

A question that will now be raised is whether this new drug is also suitable to treat major bleeding on one of the new oral anticoagulants, i.e. Xarelto, Pradaxa, or Eliquis.  It is not known whether Kcentra would be beneficial in that situation.  However, as some hospitals and clinicians presently have 3-factor PCCs on their reversal algorithm, it is fair to consider a review and possible modification of the hospital treatment guidelines on the management of major bleeding not only on warfarin, but also on the new oral anticoagulants.

 

 Reference

Sarode R et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding. A randomized, plasma-controlled, phase IIIb study. Circulation 2013;128:1234-1243.

 

Disclosure: I have consulted for CSL Behring, the comapny making Kcentra.

Last updated: Dec 13th, 2013

 

 

 

 

 

Tags: , ,

Comments are closed.