The FDA has approved a pooled plasma blood product (Octaplas) that can be used to replace coagulation factors in patients with certain medical conditions.
The product is a sterile, frozen solution of human plasma from several donors that has been treated with a solvent detergent process to minimize the risk of serious virus transmission.
The plasma used to manufacture Octaplas is collected from US donors who have been screened and tested for diseases transmitted by blood.
“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma [FFP] and provides a reduced risk of certain viral transmissions,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.
Indications and administration
Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. Octaplas can also be
used for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).
Like FFP, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. Each lot of Octaplas is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.
The product is administered by intravenous infusion after thawing, using an infusion set with a filter. An aseptic technique must be used throughout the infusion.
The dosage depends upon the clinical situation and the underlying disorder. But 12-15 mL/kg of body weight is a generally accepted starting dose, and it should increase the patient’s plasma coagulation factor levels by about 25%.
It is important to monitor patient response, both clinically and with measurement of prothrombin time, partial thromboplastin time, and/or specific coagulation factor assays.
Prior experience with Octaplas
The FDA’s approval of Octaplas was primarily based on studies conducted in patients with liver disease, liver transplant, heart surgery, and TTP. The most common adverse reactions observed in these trials were shortness of breath, dizziness, chest discomfort, pruritis/rash, headache, and paresthesia.
Additional data supporting the safe use of Octaplas for the US market came from prior use of the product in Europe and other approved markets, where it has been used extensively.
A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2006. In total, more than 2 million patients outside the US have been treated with more than 7 million doses of Octaplas.
The product is manufactured by Octapharma, located in Vienna, Austria. For more information on Octaplas, visit the Octapharma website.
