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

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