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What is KCENTRA?

Urgent warfarin reversal with fast and sustained action vs plasma*

The only 4-Factor Prothrombin Complex Concentrate (4F-PCC) indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with:

  • Need for urgent surgery/invasive procedure or
  • Acute major bleeding
Trusted experience 10+ years in the US; 20+ years as Beriplex outside the US

*Effective hemostasis measured up to 24 hours for the Acute Major Bleeding trial and until the end of procedure (up to 24 hours) for the Urgent Surgery/Invasive Procedures trial. Rapid INR reduction to ≤1.3 at 0.5 hours after end of infusion.3,4

Guidelines recommend PCC for urgent warfarin reversal

ACG-CAG

American College of Gastroenterology-Canadian Association of Gastroenterology—
20225

  • For patients presenting with acute GI bleeding and on warfarin–we suggest PCC compared with plasma administration

ACG-CAG

American College of Gastroenterology-Canadian Association of Gastroenterology—
20225

  • For patients presenting with acute GI bleeding and on warfarin–we suggest PCC compared with plasma administration

AHA/ASA

American Heart Association/American Stroke Association—
20226

  • 4-F PCC is recommended in preference to plasma in patients with VKA-associated spontaneous ICH and INR ≥2.0, to achieve rapid correction of INR and limit HE.
  • It may be reasonable to use PCC to achieve rapid correction of INR and limit HE in patients with VKA-associated spontaneous ICH with INR of 1.3 to 1.9.
  • In patients with direct factor Xa inhibitor–associated spontaneous ICH, a 4-F PCC or activated PCC (aPCC) may be considered to improve hemostasis.
  • In patients with dabigatran-associated spontaneous ICH, when idarucizumab is not available, aPCC or PCCs may be considered to improve hemostasis.

AHA/ASA

American Heart Association/American Stroke Association—
20226

  • 4-F PCC is recommended in preference to plasma in patients with VKA-associated spontaneous ICH and INR ≥2.0, to achieve rapid correction of INR and limit HE.
  • It may be reasonable to use PCC to achieve rapid correction of INR and limit HE in patients with VKA-associated spontaneous ICH with INR of 1.3 to 1.9.
  • In patients with direct factor Xa inhibitor–associated spontaneous ICH, a 4-F PCC or activated PCC (aPCC) may be considered to improve hemostasis.
  • In patients with dabigatran-associated spontaneous ICH, when idarucizumab is not available, aPCC or PCCs may be considered to improve hemostasis.

ACC

American College of Cardiology (ACC)—
20207

For reversal of warfarin, administer 4F-PCC:

  • INR 2 to <4, 25 units/kg
  • INR 4-6, 35 units/kg
  • INR >6, 50 units/kg

Or low fixed-dose option:

  • 1000 units for any non-intracranial major bleed
  • 1500 units for ICH

ACC

American College of Cardiology (ACC)—
20207

For reversal of warfarin, administer 4F-PCC:

  • INR 2 to <4, 25 units/kg
  • INR 4-6, 35 units/kg
  • INR >6, 50 units/kg

Or low fixed-dose option:

  • 1000 units for any non-intracranial major bleed
  • 1500 units for ICH

ACEP

American College of Emergency Physicians—
20198

  • Non-bleeding patients: 2.5-25 mg PO to decrease INR, Major bleeding: 5 to 10 mg slow IV injection, in addition to 4-factor PCC

ACEP

American College of Emergency Physicians—
20198

  • Non-bleeding patients: 2.5-25 mg PO to decrease INR, Major bleeding: 5 to 10 mg slow IV injection, in addition to 4-factor PCC

ACS

American College of Surgeons (ACS)—
20189

  • Administer vitamin K and 4-factor PCC to patients with an elevated INR secondary to warfarin who are actively bleeding and/or require urgent operation.

ACS

American College of Surgeons (ACS)—
20189

  • Administer vitamin K and 4-factor PCC to patients with an elevated INR secondary to warfarin who are actively bleeding and/or require urgent operation.

ASH

American Society of Hematology (ASH)—
201810

  • For patients with life-threatening bleeding during VKA treatment of VTE who have an elevated INR, the ASH guideline panel suggests using 4-F PCCs rather than plasma
  • For patients with life-threatening bleeding during oral direct Xa inhibitor treatment of VTE, the ASH guideline panel suggests using either 4-factor PCC administration as an addition to cessation of oral direct Xa inhibitor or cessation of oral direct Xa inhibitor alone.

ASH

American Society of Hematology (ASH)—
201810

  • For patients with life-threatening bleeding during VKA treatment of VTE who have an elevated INR, the ASH guideline panel suggests using 4-F PCCs rather than plasma
  • For patients with life-threatening bleeding during oral direct Xa inhibitor treatment of VTE, the ASH guideline panel suggests using either 4-factor PCC administration as an addition to cessation of oral direct Xa inhibitor or cessation of oral direct Xa inhibitor alone.

NCS + SCCM

Neurocritical Care Society and Society of Critical Care Medicine—
201611

  • Recommend administering 3-factor or 4-factor PCC rather than plasma to patients with VKA-associated intracranial hemorrhage and INR ≥1.4.

NCS + SCCM

Neurocritical Care Society and Society of Critical Care Medicine—
201611

  • Recommend administering 3-factor or 4-factor PCC rather than plasma to patients with VKA-associated intracranial hemorrhage and INR ≥1.4.

The Circular

Circular Information for the Use of Human Blood and Blood Components—
201712

  • This Circular was prepared jointly by the AABB, the American Red Cross, America's Blood Centers, and the Armed Services Blood Program. The Food and Drug Administration recognizes this Circular of Information as an acceptable extension of container labels.
  • Do not use plasma when coagulopathy can be corrected more effectively with specific therapy, such as vitamin K, cryoprecipitated AHF (antihemophilic factor), prothrombin complex concentrates used to reverse warfarin, or specific coagulation factor concentrates.

The Circular

Circular Information for the Use of Human Blood and Blood Components—
201712

  • This Circular was prepared jointly by the AABB, the American Red Cross, America's Blood Centers, and the Armed Services Blood Program. The Food and Drug Administration recognizes this Circular of Information as an acceptable extension of container labels.
  • Do not use plasma when coagulopathy can be corrected more effectively with specific therapy, such as vitamin K, cryoprecipitated AHF (antihemophilic factor), prothrombin complex concentrates used to reverse warfarin, or specific coagulation factor concentrates.

CHEST

American College of Chest Physicians—
201213

  • For patients with VKA-associated major bleeding, we suggest rapid reversal of anticoagulation with four-factor prothrombin complex concentrate (PCC) rather than with plasma.

CHEST

American College of Chest Physicians—
201213

  • For patients with VKA-associated major bleeding, we suggest rapid reversal of anticoagulation with four-factor prothrombin complex concentrate (PCC) rather than with plasma.

In 2 Head-to-Head Trials, KCENTRA
Demonstrated Superiority to Plasma in

3   of   4

efficacy endpoints