From Gabor Varadi, Einstein Healthcare:
Hello George, I would like to ask your opinion about using 4-component prothrombin complex concentrate (PCC) for rivaroxaban and dabigatran-induced life-threatening bleeding. Any scientific data to support using this product? Thank you.
Hello, Dr. Varadi, and thank you for your question. Kcentra, from CLS Behring, has been available since 2009 under the trademark Beriplex in Europe, and was USA FDA-cleared for reversal of warfarin overdose in the spring of 2013. Kcentra is a 4-factor PCC, indicating it provides therapeutic levels of factors II, VII, IX, and X, whereas current PCCs provide little VII. Though its use for neutralizing the direct oral anticoagulants (DOACs) is off-label, it appears to partially reverse rivaroxaban and apixaban overdose-generated bleeding per the attached meta-analysis, Kreuziger LMB, Keenan JC, Morton CT, Dries DJ. Management of the bleeding patient receiving new oral anticoagulants: a role for prothrombin complex concentrates. BioMed Res Intl 2014, http://dx.doi.org/10.1155/2014/583794. Kcentra appears to offer no reduction to dabigatran overdose-induced bleeding. I hope this is helpful.
Another recent opinion from the journal Blood:
“In additi
Another recent opinion from the journal Blood:
“In addition to the maximum supportive measures described above, nonspecific reversal therapies may be considered based on available, but limited, evidence. activated protein C complex (APCC, 80 U/kg) is weakly preferred over PCC for dabigatran-associated bleeding, whereas 4-factor PCC (50 U/kg) is weakly preferred over APCC for rivaroxaban- or apixaban-associated bleeding; however, use of either agent is based on poor-quality data and as such should not be considered a requirement in the setting of severe or life-threatening bleeding.”
Siegal DM, Garcia DA, Crowther MA. How I treat target-specific oral anticoagulant-associated bleeding. Blood. 2014;123:11528.
http://www.bloodjournal.org/content/123/8/1152.long?sso-checked=true