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10/4/2018

Prothrombin Complex Concentrate (Kcentra)

Reason for the Shortage

    • CSL Behring had short-term delays in product releases.[1]

Available Products

    • Kcentra, CSL Behring, 1000 unit vial, 1 kit, NDC 63833-0387-02
    • Kcentra, CSL Behring, 500 unit vial, 1 kit, NDC 63833-0386-02

Estimated Resupply Dates

    • CSL Behring has Kcentra available.[1]

Safety

    • CSL Behring recalled some Kcentra 1000 unit vials due to potential for breaking during transportation. The affected lots include M9560111E, N1260111A, and N1360111A.

Alternative Agents & Management

    • Reserve supplies of Kcentra for patients on warfarin with life-threatening bleeding. Consider fixed dosing of KCentra to conserve supply.[2]
    • Consider FEIBA (activated 4-PCC) as a potential alternative to Kcentra.[3]
    • Fresh frozen plasma is an alternative, but there is concern of circulatory overload.
    • Supportive care and control of bleeding should always be first line.

References

    1. CSL Behring (personal communication). June 25, August 1 and 15, and October 4, 2018.
    2. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants. J Am Coll Cardiol 2017; Epub Ahead of Print.
    3. Stewart WS, Pettit H. Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin related bleeding. Am J Emerg Med 2013; 1251-1254

Updated

Updated October 4, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 2, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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