About KCENTRA

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About warfarin and warfarin reversal

Warfarin is used to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events after myocardial infarction.1 Unfortunately, the most common adverse reaction to warfarin is hemorrhage,1 which is associated with hospital stays, transfusions, endoscopy, surgery, and intensive care unit (ICU) admission.2

When selecting a warfarin reversal agent, the efficacy and time to international normalized ratio (INR) reduction should be considered.3 While physicians may be comfortable with fresh frozen plasma (FFP),4 FFP has presented its own set of risks, namely fluid overload, which is associated with higher total hospital costs and longer hospital length of stay (LOS) and ICU LOS as compared with individuals without fluid overload.5

As an alternative, KCENTRA offers superior and sustained INR reduction and faster administration, with approximately 85% less volume vs plasma in pivotal trials. In the pivotal trials, there were 9 subjects (4.7%) in the KCENTRA group who experienced fluid overload; all were deemed non–treatment-related. Twenty-five subjects (12.7%) in the FFP group experienced fluid overload; 13 were deemed treatment-related.

KCENTRA offers superior INR reduction to FFP.6,7

The relationship between INR values and clinical hemostasis in patients has not been established.

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What is KCENTRA?

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 need for an urgent surgery/invasive procedure.

KCENTRA is for intravenous use only.

Please see full prescribing information for KCENTRA.
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What are the key benefits?

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KCENTRA is an effective warfarin reversal agent

with lower adverse events vs FFP, including no fluid overload events directly related to KCENTRA in pivotal trials
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KCENTRA is provided at a comparable cost point

when factoring cost components associated with FFP fluid overload8

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

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.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Coumadin. Prescribing information. Bristol-Myers Squibb Company; 2017. 2. Guerrouij M, Uppal CS, Alklabi A, Douketis JD. The clinical impact of bleeding during oral anticoagulant therapy: assessment of morbidity, mortality and post-bleed anticoagulant management. J Thromb Thrombolysis. 2011;31(4):419-423. doi:10.1007/s11239-010-0536-7 3. Frontera JA, Lewin JJ 3rd, Rabinstein AA, et al. Guideline for reversal of antithrombotics in intracranial hemorrhage: executive summary. A statement for healthcare professionals from the Neurocritical Care Society and the Society of Critical Care Medicine. Crit Care Med. 2016;44(12):2251-2257. doi:10.1097/CCM.0000000000002057 4. Data on file. Available from CSL Behring as DOF KCT-004. 5. Magee G, Zbrozek A. Fluid overload is associated with increases in length of stay and hospital costs: pooled analysis of data from more than 600 US hospitals. Clinicoecon Outcomes Res. 2013;5:289-296. doi:10.2147/CEOR.S45873 6. Goldstein JN, Refaai MA, Milling TJ Jr, et al. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015;385(9982):2077-2087. doi:10.1016/S0140-6736(14)61685-8 7. Sarode R, Milling TJ Jr, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013;128(11):1234-1243. doi:10.1161/CIRCULATIONAHA.113.002283 8. Data on file. Available from CSL Behring as DOF KCT-005.

KCENTRA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

KCENTRA® is a registered trademark of CSL Behring GmbH.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

©2022 CSL Behring. The product information presented on this page is intended for US residents only.

KCT-0126-OCT22

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