20+
years of clinical experience as Beriplex® outside the US
Kcentra 4F-PCC for urgent warfarin reversal
What is Kcentra?

Urgent warfarin reversal with fast and sustained action*

20+
years of clinical experience as Beriplex® outside the US
Kcentra 4F-PCC for urgent warfarin reversal

Guidelines recommending 4F-PCC for urgent warfarin reversal

Download additional information about the societies supporting PCC and a useful guide for identifying bleed severity below.

  • Neurocritical Care Society (NCS) and Society of Critical Care Medicine (SCCM)–20161

    "Benefits of PCC include its fast preparation and reconstitution time, rapid INR reversal, small volume, and lower risk of infection as compared to [plasma]." "PCC use in VKA-associated intracranial hemorrhage leads to faster INR reversal, less hematoma expansion, and similar or better mortality rates and functional outcomes compared to [plasma]."
  • American College of Cardiology–20172

    "[For patients with VKA-associated major bleeding], administration [of vitamin K] must be accompanied by a repletion strategy (PCCs or plasma only if 4-factor PCC…is unavailable)…PCC can be given in a much smaller volume and at a much faster infusion rate…compared with plasma and is preferred."
  • American College of Chest Physicians (ACCP)–20123

    "For patients with VKA-associated major bleeding, we suggest rapid reversal of anticoagulation with [4-factor PCC] rather than with plasma."
  • American Society for Gastrointestinal Endoscopy (ASGE)–20164

    "For warfarin…reversal, the 4-factor PCC is the appropriate reversal agent."
  • American College of Surgeons (ACS)–20185

    "[For elderly patients with TBI,] aggressive and early reversal of anticoagulant therapy may improve outcome. This result may be accomplished rapidly with the use of [PCC], plasma and vitamin K."
  • Circular of Information for the Use of Human Blood Components–20136

    "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 [FFP] when coagulopathy can be corrected more effectively with specific therapy, such as vitamin K, cryoprecipitated AHF (antihemophilic factor), [PCCs] used to reverse warfarin, or specific coagulation factor concentrates."
Top of Page Important Safety Information
Important Safety Information & Indications

Important Safety Information

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Indications

Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

Please see full prescribing information for Kcentra.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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