The FDA has approved Octaplas (Octapharma), a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

Octaplas is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from U.S. donors who have been screened and tested for diseases transmitted by blood, and determined to be suitable donors. Like Fresh Frozen Plasma, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. Each lot is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.

The licensing of Octaplas was primarily based on clinical studies conducted in patients with liver disease, liver transplant, heart surgery and TTP. Additional data supporting the safe use of Octaplas came from prior use of the products in Europe and other approved markets. 

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