Raplixa™: A Review in Improving Surgical Haemostasis

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.

A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery

“…[1][2][3][4][5]22,23 The safety profile of the current study was similar to the safety profile described in controlled clinical trials of other FS products, including Evicel, 9,24 Tisseel, 10,11 Tachosil, 25,26 and Raplixa. 27 Treatment with FS Grifols did not seem to be related with a higher risk than treatment with MC. The natures of AEs reported are to be expected in patients with severe vascular disease undergoing arterial surgical procedures.…”

Fibrin Sealants: Challenges and Solutions

“…Furthermore, this system was used for the coadministration of drug substances such as fibroblast growth factor 2 to stimulate fibroblast proliferation during tissue regeneration. − Raplixa applies both fibrinogen and thrombin as a powder spray, driven by a gas flow generator with an agitator by which the components are directly deposited onto the injury site. − This powder approach has advantages compared to liquid fibrin glues in that the components are stable at room temperature (Figure ). , Another recently approved product is a fibrin patch for wound sutures called Evarrest (Ethicon, Inc.). It combines bioresorbable suture components (Vicryl and poly­(lactide- co -glycolide)) with a cellulose matrix being coated with both human fibrinogen and human thrombin. − Upon contact with wound fluids, the forming fibrin clot integrates the patch into the wound.…”

“…86−88 This powder approach has advantages compared to liquid fibrin glues in that the components are stable at room temperature (Figure 4). 89,90 Another recently approved product is a fibrin patch for wound sutures called Evarrest (Ethicon, Inc.). It combines bioresorbable suture components (Vicryl and poly(lactide-co-glycolide)) with a cellulose matrix being coated with both human fibrinogen and human thrombin.…”

Manufacturing strategies to develop amorphous solid dispersions: An overview

“…Summary of Hot Melt Extrusion, Kinetisol®, Spray drying, and Fluidized bed Technology processes to formulate amorphous solid dispersions [49,51,88,[117][118][119][120][121][122][123][124][125][126][127].…”