FRIDAY, May 1, 2015 (HealthDay News) — Raplixa (human fibrin sealant) has been approved by the U.S. Food and Drug Administration to help control bleeding during surgery, the agency said in a news release.
Raplixa’s use is sanctioned when standard surgical techniques — including sutures — are “ineffective or impractical,” the FDA said. The spray-dried product is dissolved in the blood and triggers a reaction that promotes clotting to help stop bleeding.
The product contains fibrinogen and thrombin, two proteins derived from human plasma. Its manufacturing process includes purification designed to render blood-borne viruses inactive, the agency said.
Raplixa, designed to be used with an absorbable gelatin sponge, was clinically evaluated among more than 700 people over 11 months. The most common side effects included surgical pain, nausea, constipation, fever and lower blood pressure.
The product is manufactured by ProFibrix BV, a unit of The Medicines Company, based in Parsippany, N.J.
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