anyone have experience with Kcentra?

[nap$ter]

we have a drug rep dinner coming up - anyone used it? have an opinion on it? looks like studies are sparse but sounds like a great product not only for coumadin reversal but maybe also intraop coagulopathy...

i'm sure it will be prohibitively expensive, but FFP ain't exactly cheap either.

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[urge]

Isn't that a reportable event per Sunshine Act?

I think you are better off taking your wife for dinner. Too much headache.

 

[nap$ter]

Isn't that a reportable event per Sunshine Act?

I think you are better off taking your wife for dinner. Too much headache.

sure - it's reportable (unless i only drink water).

i'll bite - why should i care if the pharm company reports my dinner tab?

 

[Planktonmd]

It is a good option for emergent reversal of Warfarin in patients who could not handle the extra volume load from FFP.
Basically a patient with a very low EF who needs emergency surgery might be a good candidate

 

[BLADEMDA]

Kcentra (prothrombin complex concentrate [human]) and FEIBA (factor eight inhibitor bypassing activity) are the two 4-factor PCCs currently available in the U.S. (TABLE 2).14,15 FEIBA is the only commercially available activated 4-factor PCC, as it contains factor VII primarily in the activated form.20 Kcentra was approved by the FDA in April 2013.14 The primary concern with using activated PCC is the subsequent increased thrombotic risk.20 The safety and efficacy of 4-factor PCCs in hemorrhagic patients has not been assessed in large systematic studies. - See more at: http://www.uspharmacist.com/content/d/feature/c/46254/#sthash.VnSlVBAH.dpuf

 

[BLADEMDA]

http://depts.washington.edu/anticoa...c Spontaneous Intraparenchymal Hemorrhage.pdf

While not approved for the new anticoagulants like Pradaxa, Xarelto, Eliquis, etc. I would use KCentra in an emergency situation where immediate reversal was required.

 

[BLADEMDA]

Pharma is developing reversal agents for Factor Xa inhibitors: http://www.medpagetoday.com/Cardiology/Prevention/45371


John Curnutte, MD, PhD, executive vice president for research and development at Portola Pharmaceuticals, was one of three pharma executives who presented overviews of reversal agents currently in development. Portola's andexanet, a lyophilized reversal agent for all Factor Xa inhibitors and likely also low molecular weight heparin, is the one that has been most closely followed. It is, however, not an antidote for dabigitran, which is a direct thrombin inhibitor.


The Portola agent was granted breakthrough therapy status by the FDA and is currently in a Phase III trial.

Curnutte said that Phase II trials of the drug "near complete reversal" of Factor Xa inhibition, with gradual clearance of the reversal agent over 1-2 hours. In addition to removing the Factor Xa inhibitor from plasma, he said andexanet pulls the inhibitor from the tissue.

 

[deleted547339]

I've used it a handful of times in the ER. Seemed to work well.

Once in a GI bleed with bad CHF.

Other times were GI bleeds that were bleeding to death.

 

[deleted126335]

sure - it's reportable (unless i only drink water).

i'll bite - why should i care if the pharm company reports my dinner tab?

Like Caesar's wife doctors are supposed to be above reproach and avoid even the appearance of impropriety.

I have used it once. Wasn't terribly concerned about the cost. Was very concerned about the potential for thrombotic complications. Worked well. No complications. It is expensive.

 

[jwk]

Isn't that a reportable event per Sunshine Act?

I think you are better off taking your wife for dinner. Too much headache.

Not sure what, if any, reporting is required from the physician end, but my wife (an infusion company rep) has to provide detailed weekly reports to her corporate office, who is responsible for tracking the costs of anything and everything she provides a physician and their office staff. A dozen donuts for the office at $1 each? If the physician eats one, that $1 expense is supposed to be tracked for that individual physician. If anyone in the physician's family eats one, it goes against the physician's limit. The office staff can eat all the rest and it doesn't matter. When they get to 80% of their dollar limit (which I think is some weird number like $385/yr) they get a notice from the office telling them they're near the limit and should stop taking stuff.

 

[urge]

sure - it's reportable (unless i only drink water).

i'll bite - why should i care if the pharm company reports my dinner tab?

I don't think a 10 oz steak and a glass of wine factor favorably against a paper trail with unknown (but most likely machiavellic) repercussions.

 

[bigdan]

It is a good option for emergent reversal of Warfarin in patients who could not handle the extra volume load from FFP.
Basically a patient with a very low EF who needs emergency surgery might be a good candidate

PCC are not only a good option, but the suggested agent for urgent reversal of warfarin. For everyone. Per Chest guidelines:
9.3. For patients with VKA-associated major bleeding, we suggest rapid reversal of anticoagulation with four-factor prothrombin complex concentrate (PCC) rather than with plasma.

 

[BLADEMDA]

Vitamin K antagonists (VKAs), such as warfarin, are widely used for prevention and treatment of arterial and venous thrombosis. Although oral or intravenous vitamin K and fresh frozen plasma are often used to reverse the anticoagulant effects of warfarin in patients who are bleeding, this approach has important limitations. Restoration of hemostasis with vitamin K relies on the hepatic synthesis of vitamin K–dependent procoagulant proteins, factors II (prothrombin), VII, IX, and X, a process that takes >6 hours. Fresh frozen plasma provides an immediate source of functional vitamin K–dependent clotting proteins, but large volumes are often required to normalize the international normalized ratio (INR). This can be problematic because it takes time to match blood type and thaw and infuse fresh frozen plasma, and the large volumes can lead to fluid overload, particularly in patients with compromised cardiac or renal function.

Current guidelines recommend 4-factor PCC for situations where rapid reversal of VKA-induced coagulopathy is needed, such as in patients who require urgent surgery or in those with a life-threatening bleed.1,3–5 If 4-factor PCC is unavailable, 3-factor PCC can be used, and some clinicians supplement it with fresh frozen plasma or small amounts of recombinant activated factor VII (factor VIIa) as a source of factor VII. Nonactivated PCC is preferred over activated PCC, which contains factor VIIa, as well as factors II, IX and X, or recombinant factor VIIa, because there is likely to be a lower risk of thromboembolic events with nonactivated products.6,7 In addition, recombinant factor VIIa only replaces 1 of the 4 vitamin K–dependent procoagulant proteins.


http://circ.ahajournals.org/content/128/11/1179.full

 

[BLADEMDA]

Fresh frozen plasma (FFP) is the
most widely used coagulation factor replacement product in
North America for VKA reversal (7–9). However, FFP is not optimal
for immediate correction of VKA-associated coagulopathy because
it may transmit infectious agents, it causes allergic reactions
and volume overload, it rarely completely corrects the International
Normalised Ratio (INR) and unless a supply of thawed
plasma is kept on hand, and its administration is delayed as it
requires thawing and slow administration (10).
Unlike FFP, PCCs are stored as lyophilized powders, and are not
blood-group specific. In addition, PCCs contain a high clotting
factor concentration which can be administered quickly in small
volumes. As a result of these advantages, PCCs are thought to correct
VKA-related coagulopathy more rapidly than FFP (7). Several
international guidelines support PCCs as the treatment of choice
for reversal of the anticoagulant effect of VKAs (11)

 

[BLADEMDA]

Originally developed as a source of factor IX for treatment of patients with hemophilia B, 3-factor PCC contains factors II, IX, and X but little or no factor VII. In contrast to 3-factor PCC, 4-factor PCC also contains significant amounts of factor VII. Both 3- and 4-factor PCC contain protein C and protein S, and some may also contain small amounts of heparin, which is added to prevent activation of the clotting proteins.

 

[deleted547339]

PCCs are great for fixing the number and, like I said above, I've had good personal experience. However, if I remember correctly, they do not improve any patient centered outcome and may have a trend torwards higher mortality.

 

[BLADEMDA]

The safety profiles of PCC and fresh frozen plasma were comparable, as were the rates of thromboembolic events (7.8% and 6.4%, respectively), mean number of units of packed red blood cells transfused (1.4 and 1.2, respectively), and the median length of hospital stay. Patients in the PCC group had a lower rate of treatment-related adverse events than those given plasma (9.7% and 21.1%, respectively). There were 10 deaths in the PCC group and 5 in the group given fresh frozen plasma, but only 1 death was deemed to be treatment related.

Second, the 7% to 8% overall rate of thromboembolic events and the 3% to 4% rate of treatment-related thromboembolism reported in this study underscore the importance of appropriate use of PCC in patients with VKA-associated coagulopathy. Although direct evidence that PCC or fresh frozen plasma causes thrombosis is lacking, there is substantial evidence that reversal of antithrombotic therapy in patients at risk is associated with an increase in thromboembolic events. Consequently, it seems prudent to restrict the use of PCC or fresh frozen plasma to patients with major or life-threatening bleeding or to those requiring urgent surgery.

 

[bcat85]

I actually used this for the first time about 2 weeks ago, though it was in a slightly different context. We had a heart/arch repair that had refractory coagulopathic bleeding after a very long bypass run. We gave all of the usual stuff plus Novo-7 and we were still bleeding so we gave some Kcentra. It actually seemed to help, as the patient dried up pretty well over the next 10 minutes or so. Went to a talk on this a few months ago, and it seems that some institutions have started using this as part of their massive transfusion protocols as well.

N=1 though.

 

[urge]

I have used it several times with good results.

 

[nimbus]

Necrobump.....damn