KCentra Contents and Dosing

kcentra dose and contents

 

#1

Kcentra: coumadin reversal in acute major bleeding or need for urgent surgery:  

  • Pretreatment INR: 2 to <4: Administer 25 units/kg; maximum dose: 2,500 units
  • Pretreatment INR: 4 to 6: Administer 35 units/kg; maximum dose: 3,500 units
  • Pretreatment INR: >6: Administer 50 units/kg; maximum dose: 5,000 units

*Dosage expressed in units of factor IX activity
*give concurrent vitamin K
*Repeat dosing is not recommended (has not been studied).

 

#2

Life-threatening hemorrhage with DOACs: (off label)

Optimal dosing not established

European Heart Rhythm Association, 50 units/kg (+25 units/kg if clinically necessary) recommended based on limited evidence in healthy volunteers

ICH due to various antithrombotic agents (NCS/SCCM [Frontera 2016]):

  • apixaban, edoxaban, rivaroxaban:
    • 50 units/kg if ICH within 3 to 5 terminal half-lives of drug exposure or when liver failure co-exists.
  • argatroban, dabigatran [if idarucizumab unavailable], bivalirudin, desirudin:
    • 50 units/kg if administered within 3 to 5 half-lives prior and no renal failure or there is renal impairment leading to drug exposure beyond 3 to 5 half-lives

 

FIXED vs. VARIABLE DOSE

Advantages of fixed dose KCentra:

  1. eliminates need for dose calculation based on patient-specific variables
  2. earlier start of hemostasis – limits hematoma enlargement?
  3. easier administration, no complex tables, reduction of door-to-needle time
  4. ?better clinical outcome

Retrospective study from Netherlands – fixed dose 1000 IU fIX PCC, ffd by 500 IU if INR>1.5, used Cofact (Sanquin BV) which contains FII FVII FIX FX and PrC and PrS, no activated factors or heparin. CONCLUSION:  that fixed dose required further dose/s to achieve target INR.  Door-to-needle time shorter, but not significant.  ?clinical outcome unknown.

Bottom line:  For now, calculate dose based on weight and INR.

 

 

 

 

 

References

“Prothrombin complex concentrate, 4-factor, unactivated, from human plasma”. Uptodate.com. Accessed 13 Dec. 2016.

Kcentra product insert.

Abdoellakhan, Rahat Amadkhan et al. “Fixed Versus Variable Dosing Of Prothrombin Complex Concentrate In Vitamin K Antagonist-Related Intracranial Hemorrhage: A Retrospective Analysis”. Neurocritical Care 26.1 (2016): 64-69.

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