FDA Approves Octaplas
- By BSTQ Staff
Octapharma USA’s Octaplas, a solvent/ detergent-treated pooled human plasma, has been approved by the U.S. Food and Drug Administration to manage preoperative or bleeding patients who require replacement of multiple plasma coagulation factors and patients with coagulation deficiencies due to hepatic disease or who are undergoing cardiac surgery or liver transplantation, as well as for transfusion or plasma exchange in patients with congenital or acquired thrombotic thrombocytopenic purpura.
Solvent/detergent treatment is a well-recognized method for reducing highly infectious enveloped viruses. Octaplas is designed to improve viral safety, avoid transfusion-related acute lung injury and nonhemolytic allergic reactions, and provide standardized levels of coagulation factors equivalent to single donor fresh frozen plasma.
“Plasma pooling, cell filtration and solvent/detergent treatment may neutralize antibodies against white blood cell antigens and reduce bioactive lipids known to mediate the development of transfusion-related acute lung injury, a severe yet underreported cause of transfusion-associated morbidity and mortality,” said Anitha Vijayan, MD, director of the acute dialysis unit and associate professor of medicine at the Washington University School of Medicine in St. Louis.
