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FDA approves Octaplas to treat patients with blood clotting disorders
The FDA today approved Octaplas for treatment of patients with insufficient levels of clotting proteins.
Octaplas (Octapharma) is a sterile, frozen solution of pooled human plasma from several US donors, according to an FDA press release. All donors are screened and tested for diseases transmitted by blood.
The solution is treated with a solvent detergent process that kills certain viruses. Each lot also is tested for composition of key clotting factors, and the solution is only released if levels are determined to be within the acceptable range, according to the FDA.
“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma and provides a reduced risk of certain viral transmissions,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.
To reduce the risk of transfusion reactions, Octaplas should be matched to the recipient’s blood group.
Octaplas, first marketed in 1992, has been used extensively outside the United States. More than 7 million doses have been used to treat more than 2 million people, according to the FDA.
The FDA based its decision to approve Octaplas on its safe use in Europe and other regions, as well as on results of clinical studies that involved patients with liver disease or thrombotic thrombocytopenic purpura, and patients who had undergone liver transplant or heart surgery.
The most common adverse effects reported in the clinical trials included dizziness, shortness of breath, skin itchiness and rashes, chest discomfort, headache and tingling sensations.
The use of Octaplas has not been associated with transfusion-related acute lung injury, a rare adverse effect of transfusion with single plasma units.