Patient Education Blog

Kcentra – FDA Approval of New Drug for Reversal of Warfarin

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 the plasma of multiple healthy blood donors and contains the clotting 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 treat major bleeding in warfarin-treated patients or reverse warfarin in case major surgery was urgently needed.  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 from now on give the 4-factor PCC, Kcentra.

 

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.

 

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

 

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