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Raplixa™: A Review in Improving Surgical Haemostasis

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Abstract

Raplixa™ is a novel fibrin sealant containing a blend of human fibrinogen and thrombin in powder form. It is approved in adults to help control bleeding when standard surgical techniques have been insufficient. This article summarizes the product characteristics of Raplixa and provides a narrative review of its clinical use and tolerability. Unlike other available fibrin sealants, including liquid agents and lyophilized powders, the dry-powder, ready-to-use formulation of Raplixa provides potential advantages, including ease of storage and use. In the randomized, phase III FINISH-3 study, Raplixa plus gelatin sponge was superior to gelatin sponge alone in reducing the time to haemostasis in adults who developed mild or moderate bleeding uncontrolled by conventional surgical techniques while undergoing spinal, vascular, hepatic or soft-tissue surgical procedures. Raplixa was well tolerated, with a similar safety profile to that observed in the gelatin-sponge-alone group. Thus, Raplixa provides an easy to store and use option for improving haemostasis in adults when standard surgical techniques are ineffective or impractical.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comments on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. Kate McKeage is a salaried employee of Adis/Springer.

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Correspondence to Kate McKeage.

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The manuscript was reviewed by: T. Cheriyan, Division of Spine Surgery, Department of Orthopaedic Surgery, Hospital for Joint Diseases. New York, NY, USA; K. J. Grubb, Department of Cardiothoracic Surgery, University of Louisville, Louisville, KY, USA; J. Wong, Department of Anesthesia, University Health Network, University of Toronto, Toronto, Canada.

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McKeage, K. Raplixa™: A Review in Improving Surgical Haemostasis. Clin Drug Investig 35, 519–524 (2015). https://doi.org/10.1007/s40261-015-0307-5

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