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.
Similar content being viewed by others
References
Gabay M, Boucher BA. An essential primer for understanding the role of topical hemostats, surgical sealants, and adhesives for maintaining hemostasis. Pharmacotherapy. 2013;33(9):935–55.
Shander A, Kaplan LJ, Harris MT, et al. Topical hemostatic therapy in surgery: bridging the knowledge and practice gap. J Am Coll Surg. 2014;219(3):570–9.e4.
Spotnitz WD. Fibrin sealant: the only approved hemostat, sealant, and adhesive—a laboratory and clinical perspective. ISRN Surg. 2014. doi:10.1155/2014/203943.
European Medicines Agency. Raplixa: summary of product characteristics. 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002807/WC500186418.pdf. Accessed 6 May 2015.
The Medicines Company. Raplixa (Fibrin sealant (human)): US full prescribing information. 2015. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM445346.pdf. Accessed 6 May 2015.
Bochicchio GV, Gupta N, Porte RJ, et al. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015;220(1):70–81.
European Medicines Agency. Summary of the risk management plan (RMP) for Raplixa (human fibrinogen/human thrombin). 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Risk-management-plan_summary/human/002807/WC500180548.pdf. Accessed 3 Jun 2015.
Versteeg HH, Heemskerk JW, Levi M, et al. New fundamentals in hemostasis. Physiol Rev. 2013;93(1):327–58.
Ruitenbeek K, Ayez N, Verhoef C, et al. Safety and efficacy of a novel, dry powder fibrin sealant for hemostasis in hepatic resection. Dig Surg. 2014;31(6):422–7.
Verhoef C, Singla N, Moneta G, et al. Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials. J Surg Res. 2015;194(2):679–87.
Practice guidelines for perioperative blood management: an updated report by the American Society of Anaethesiologists Task Force on Perioperative Blood Management. Anaesthesiology. 2015;122:241–75.
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.
Author information
Authors and Affiliations
Corresponding author
Additional information
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.
Rights and permissions
About this article
Cite this article
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
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40261-015-0307-5