BETHESDA, MD 18 Jan 2013—FDA on January 17 announced the approval of Octaplas, a solvent–detergent treated pooled human plasma product for use in certain patients with coagulation factor deficiencies.
Octaplas is indicated for the replacement of multiple coagulation factors in patients who have liver disease or are undergoing cardiac surgery or liver transplantation and for plasma exchange in patients with thrombotic thrombocytopenic purpura.
FDA described Octaplas as an alternative to single-donor fresh-frozen plasma. The product is marketed by Vienna, Austria-based Octapharma.
Octapharma has not announced a U.S. launch date or distribution network for Octaplas. A list of Octapharma-authorized distributors is posted on the company's website.
The labeling (PDF) for Octaplas emphasizes that the product must be matched to each patient's ABO blood group before administration.
Octaplas is contraindicated in patients with IgA deficiency, severe protein S deficiency, or a history of hypersensitivity to the product or to fresh frozen plasma, plasma-derived products, or any plasma protein.
Octaplas is prepared from pooled human plasma from multiple U.S. donors who are screened for the presence of blood-transmissible diseases. The solvent–detergent treatment further reduces the risk of transmission of adventitious viruses that may be present in the donor plasma.
The product is administered by i.v. infusion using a weight-based dosage when given for coagulation factor replacement and a volume-based dosage when given for plasma exchange.
Various versions of Octaplas have been used in Europe since 1992, according to FDA. The agency stated that Octaplas use in Europe is not associated with transfusion-related acute lung injury, a rare but serious adverse event that may occur after transfusion with single units of plasma.
According to FDA, the most frequently reported adverse events in clinical studies of Octaplas included shortness of breath, dizziness, chest discomfort, skin itchiness, rashes, headache, and tingling sensations.
Octaplas will be supplied in polyvinyl chloride blood bags containing 200 mL of frozen solution. The product should be stored at ≤18 °C and thawed before use as described in the labeling.
Once thawed, Octaplas should be used within 12 hours if kept at 2–4 °C or within 3 hours if stored at 20–25 °C. Do not refreeze the product.