FDA Approves Raplixa to Help Control Bleeding During Surgery

Megan Brooks

April 30, 2015

The US Food and Drug Administration (FDA) has approved the first spray-dried fibrin sealant to control bleeding during surgery.

Raplixa (fibrin sealant, human) is manufactured by ProFibrix BV, a subsidiary of The Medicines Company.

Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature, or cautery, are ineffective or impractical, the FDA notes in a news release.

Raplixa contains purified human plasma-derived fibrinogen and thrombin, which are spray-dried, blended, and packaged in a vial. "When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. It is approved for use in conjunction with an absorbable gelatin sponge," according to the FDA.

"This approval provides surgeons an additional option to help control bleeding during surgery when needed," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in the release.

"The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature," Dr Midthun added.

In approving Raplixa, the FDA reviewed data from a clinical study involving 719 patients undergoing different types of surgical procedures. "The study demonstrated Raplixa's effectiveness by comparing the reduction in the time needed for bleeding to stop when using this fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone," the FDA said.

The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.


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