Kcentra Administration

After the inclusion of Kcentra to the armamentarium for acute reversal of anticoagulation, a few practical issues have come up that are worth sharing.

1) Product contents:
Depending on the products previously used at a given institution (here it was Profilnine), there are several differences in the contents compared to Kcentra. One particular of note is that Kcentra contains approximately 40 units of heparin for every 500 FIX units.  Therefore a patient could receive anywhere from 200 to 400 units of heparin per dose of Kcentra.  Because of this, there is a risk of exacerbation/reactivation of HIT. In fact, Kcentra is contraindicated in patients with history of HIT (per PI).  Thus, the prospect of actually removing an item from formulary when adding an alternative may not be possible, since keeping Profilnine is necessary for patients with history of HIT. Alternatively, FEIBA contains no heparin, but may have higher relative risk of thrombosis (theoretically).

2) Administration and dilution:
Kcentra is supplied as a lyophilized powder which requires reconstitution with SWFI.   However, no further dilution is recommended. Normally not a problem for small doses (less than 50 mL volume) can be infused via syringe pump. But larger volumes require empty evacuated containers for administration. Conceptually, this may not be an issue, but practically, it is. In a hospital pharmacy, trying to find an evac bag (which are on shortage), or reconstituting the drug at the bedside (where evac bags do not exist), administration issues/delays can occur. There is no information I can find as to why it cannot be diluted further in say, 100mL of NS, but potential studies are in the works.

3) INR recheck:
It seems that the critical INR recheck 15 min after the end of the infusion is simply not being done. Partially as a result of poor education for all parties involved (pharmacy, nursing, PA, physician, lab), and partially because of poor communication at the time of the order to ensure that, “no this isnt a duplicate order, we need another INR 15min after the infusion.”

Lastly, the still “unpublished” data comparing Kcentra to FFP which led to the FDA approval is still… unpublished. I am growing more and more concerned as to why, and fearing there is more to the significant 6.1% increase in the incidence of death in the Kcentra arm vs FFP…

More to come on the evolution of the Kcentra, PCC, FEIBA, Novoseven saga.

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2 thoughts on “Kcentra Administration

  1. Great information on Kcentra! I have some further questions which you may be able to assist in. I work in a community hospital ED (no trauma) and this is the first PCC on our formulary. The package insert states to “Administer Vitamin K concurrently” – how do you interpret this? Does a patient need 2 peripheral lines to facilitate this process or can Kcentra be administered first, followed immediately by Vitamin K. What if a patient has an INR of < 2, are they still considered candidates for Kcentra and if so, what dose?Does your institution round to the nearest vial? Are you estimating 500 units of factor IX per vial or the actual factor IX units (our present stock is 537 units/vial). For example, say there is a 90 kg patient with INR 2-4, so per the recommendations this is dosed at 25 mg/kg (= 2250 units of factor IX). So how many vials would you give? If you consider each vial as 500 units, do you give 4.5 vials (or do you round and if so, do you round up or down?). If you consider the actual content of 537 units/vial, then this is about 4.2 vials, do you give the exact dose or do you round down to 4 vials (considering the expense). Our hospital has always rounded to the nearest vial for the various individual factor products (such as factor VII), but I am unsure if we should be doing this for Kcentra. Since this is our only PCC on formulary, what are your thoughts on using it to reverse other oral anticoagulants (Xarelto, Eliquis, Pradaxa). I know the evidence is limited but I know that I will be put into that difficult situation at some point and I need to be ready…would love to hear your thoughts…Great Blog! I am officially addicted 🙂

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  2. Thanks for reading!Kcentra should be administered with vitamin k in patients who were previously on warfarin (not necessary for any other anticoagulant). Any patient receiving Kcentra should probably already have two large bore (resuscitation) IV lines, but it is not necessary to administer the vitamin k at (literally) the same time. As long as they receive it ASAP. Vitamin K isnt essential for the PCC to work, but it is required to overcome vitamin K antagonism from warfarin.If the INR is less than 2 and they are bleeding, depending on the situation they may be candidates for the PCC. This is a very gray area.We do round to the nearest vial size, treating it similar to all of the other factor products. If the dose is 49% or less to the next vial dose, the dose can be rounded down. If the dose is 50% or more to the next vial dose, the dose can be rounded up. There is data with beriplex and other 4fPCCs that demonstrates it may reverse (partially) the anti-Xa drugs, but nothing seems to work reliably for dabigatran. With that said, we still will use this PCC at a dose of 50u/kg. If dabigatran, dialysis can remove the drug- just be alert for rebound and redistribution of the drug after dialysis. Importantly, we have to make sure that the patient is actually a candidate for PCC- ie, they may not tolerate the volume of FFP, they can't wait for FFP/cryoprecipitate, they are actually having a major or life threatening bleed. Thank you again for reading! We are looking to add more content soon!

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