In general, vitamin K is recommended with KCentra in warfarin-related bleeds to rapidly reverse INR (Le Roux et al.
Before 2015, reversal of dabigatran was limited to the use of FFP, rVIIa, and PCC (marketed in the United States as KCentra [CSL Behring]).
Anonactivated, 4-factor prothrombin complex concentrate (4F-PCC) known as Kcentra (CSL Behring, Kankakee, Illinois) has been approved in the United States for the reversal of vitamin K antagonist (VKA) anticoagulation in patients with major acute hemorrhage, or in patients who require urgent surgical intervention.
For instance, the analogue to Kcentra is Beriplex (CSL Behring, Marburg, Germany), a product widely used in Europe.
Kcentra contains factors II, VII, IX, and X in addition to the natural anticoagulants protein C and protein S (1) (see Table 2 for additional details on the contents of 4F-PCCs and FFP).
Kcentra has been approved in the United States for the reversal of VKA anticoagulation in patients with major acute hemorrhage, or in patients who require urgent surgical intervention.
Hemostatic efficacy at an earlier time point (4 hours) was studied only in patients with visible and/ or musculoskeletal bleeds; Kcentra was determined in those cases (and at that time point) to be superior to FFP.
9) In our experience, there are some patients who may meet one of these exclusion criteria and for whom Kcentra is requested.
For VKA reversal, Kcentra is dosed to correct INRs of 2.
The US Food and Drug Administration (FDA) has granted approval to CSL Behring's Kcentra (Prothrombin Complex Concentrate Human ) for an enlarged indication - immediate reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.
Approved by the FDA in April this year,for the immediate reversal of warfarin therapy in adult patients with critical major bleeding, Kcentra, is the sole non-activated 4-factor prothrombin complex concentrate (4F-PCC) indicated in the US for these uses.
Kcentra is an important new option for such cases; it does not require blood-type matching or thawing, and restores clotting factors more quickly than plasma.