Octapharma USA announced that the Food and Drug Administration (FDA) has approved revised product labeling for Octaplas (pooled plasma [human], solvent/detergent treated solution for intravenous infusion) to increase available time between product thawing and patient administration.
The newly approved product label indicates that thawed Octaplas can now be used within 24 hours if refrigerated (between 1°C and 6°C/33.8°F to 42.8°F) or within eight hours if stored at room temperature (between 20°C and 25°C/68°F to 77°F). Previously, the product information stated that the thawed product should be used within 12 hours if stored between 2°C and 4°C (35.6°F to 39.2°F) or within three hours if stored between 20°C and 25°C (68°F to 77°F). It can also be stored frozen, ≤-18°C (-0.4°F), for three years from the date of manufacture compared to the earlier labeling of two years.
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. It is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease, undergoing cardiac surgery, or liver transplant and for plasma exchange in thrombotic thrombocytopenic purpura (TTP).
For more information visit OctaPharma.com.