Prothrombin complex concentrates: Difference between revisions

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*Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial
*Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial
*Common Trade Names: Kcentra
*Common Trade Names: Kcentra
*3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC
*4 factor PCC (Factors II, VII, IX, and X)


==Adult Dosing==
==Adult Dosing==
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**INR 4-6: 35units/kg, not to exceed 3500 units
**INR 4-6: 35units/kg, not to exceed 3500 units
**INR >6: 50units/kg, not to exceed 5000 units
**INR >6: 50units/kg, not to exceed 5000 units
*Consider rechecking INR after 15 minutes to determine need for redosing
*Fixed dose Kcentra equivalent to weight based (while being easier to administer and less expensive)<ref>Bitonti MT et al. Prospective Evaluation of a Fixed-Dose 4-Factor Prothrombin Complex Concentrate Protocol for Urgent Vitamin K Antagonist Reversal. J Emerg Med 2019;X(XX). https://doi.org/10.1016/j.jemermed.2019.10.013</ref><ref> Fixed-Dose PCC Dosing for Vitamin K Antagonist-Associated Hemorrhage: Is it Safe and Effective? by Kayvan Moussavi http://www.emdocs.net/fixed-dose-pcc-dosing-for-vitamin-k-antagonist-associated-hemorrhage-is-it-safe-and-effective/</ref>
**Baseline INR ≤7.5 and ≤100 kg: 1500 units of Kcentra
**Baseline INR >7.5 or >100 kg: 2000 units of Kcentra


==Pediatric Dosing==
==Pediatric Dosing==
Safety and efficacy not established
*Safety and efficacy not established


==Special Populations==
==Special Populations==
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===Serious===
===Serious===
*thromboembolism
*Patients receiving PCC for reversal of a vitamin K antagonist ([[Warfarin]]) due to life-threatening bleeding have a rate of thromboembolism which is similar to the rate in patients who receive [[Fresh frozen plasma]] (7.3% v 7.1%).<ref>Milling, TJ Jr et al. Thromboembolic events after vitamin K antagonist reversal with 4-factor prothrombin complex concentrate: exploratory analyses of two randomized, plasma-controlled studies. Ann Emerg Med. 2016 Jan;67(1):96-105.  PMID: 26094105</ref>
*blood product (hepatitis, HIV)
 
===Common===
===Common===
*thromboembolic events (8.7%)
*Thromboembolic events
*[[headache]] (7.8%)
*[[Headache]]  
*[[hypotension]] (4.9%)
*[[Hypotension]] (4.9%)
*[[nausea/vomiting]]
*[[Nausea/vomiting]]
*arthralgia
*Arthralgia
*[[ICH]] (2.9%)
*[[ICH]] (2.9%)
*mental status change (2.9%)
*Mental status change
*hypertension (2.9%)
*Hypertension (2.9%)


==Pharmacology==
==Pharmacology==
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==See Also==
==See Also==
*[[Blood transfusions]]
*[[Anticoagulant reversal for life-threatening bleeds]]
*[[Dabigatran (Pradaxa) Reversal]]
*[[Anti-platelet agent reversal]]
*[[Blood products]]
*[[Warfarin reversal]]


==References==
==References==
<references/>
<references/>
[[Category:Pharmacology]]
[[Category:Pharmacology]]
[[Category:Heme/Onc]]

Revision as of 15:43, 16 June 2020

General

  • Type: Hemostatics, blood components
  • Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial
  • Common Trade Names: Kcentra
  • 3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC
  • 4 factor PCC (Factors II, VII, IX, and X)

Adult Dosing

  • Based on pretreatment INR, units based on factor 9 content
    • INR 2-4: 25units/kg, not to exceed 2500 units
    • INR 4-6: 35units/kg, not to exceed 3500 units
    • INR >6: 50units/kg, not to exceed 5000 units
  • Consider rechecking INR after 15 minutes to determine need for redosing
  • Fixed dose Kcentra equivalent to weight based (while being easier to administer and less expensive)[1][2]
    • Baseline INR ≤7.5 and ≤100 kg: 1500 units of Kcentra
    • Baseline INR >7.5 or >100 kg: 2000 units of Kcentra

Pediatric Dosing

  • Safety and efficacy not established

Special Populations

  • Pregnancy Rating: C
  • Lactation: Unknown, breast feeding not advised
  • Renal Dosing
    • Adult-N/A
    • Pediatric-N/A
  • Hepatic Dosing
    • Adult-N/A
    • Pediatric-N/A

Contraindications

  • Allergy to class/drug
  • DIC
  • known HIT (Heparin induced thrombocytopenia)

Serious

  • Patients receiving PCC for reversal of a vitamin K antagonist (Warfarin) due to life-threatening bleeding have a rate of thromboembolism which is similar to the rate in patients who receive Fresh frozen plasma (7.3% v 7.1%).[3]

Common

Pharmacology

  • Half-life: 4-60 hours, depending on clotting factor
  • Metabolism:
  • Excretion:
  • Mechanism of Action: 4 factor PCC contains factors II, VII, XI, X, protein C and S

See Also

References

  1. Bitonti MT et al. Prospective Evaluation of a Fixed-Dose 4-Factor Prothrombin Complex Concentrate Protocol for Urgent Vitamin K Antagonist Reversal. J Emerg Med 2019;X(XX). https://doi.org/10.1016/j.jemermed.2019.10.013
  2. Fixed-Dose PCC Dosing for Vitamin K Antagonist-Associated Hemorrhage: Is it Safe and Effective? by Kayvan Moussavi http://www.emdocs.net/fixed-dose-pcc-dosing-for-vitamin-k-antagonist-associated-hemorrhage-is-it-safe-and-effective/
  3. Milling, TJ Jr et al. Thromboembolic events after vitamin K antagonist reversal with 4-factor prothrombin complex concentrate: exploratory analyses of two randomized, plasma-controlled studies. Ann Emerg Med. 2016 Jan;67(1):96-105. PMID: 26094105