Octapharma USA: FDA Approves Octaplas™ License Supplement, Increasing Post Thaw Permitted Storage Time
By Business Wire News
By Business Wire News
Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved revised product labeling for Octaplas™ [Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion], which provides a significant increase in available time span between product thawing and patient administration of the biological therapy.1, 2
The newly approved product label indicates 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 8 hours if stored at room temperature (between 20°C and 25°C/68°F to 77°F). Previous product information had directed that 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).1, 2
In January 2013, Octapharma USA, a subsidiary of global human protein products manufacturer Octapharma AG, received approval for Octaplas™, the only FDA-licensed pooled, solvent/detergent (S/D) treated plasma for transfusion. The FDA classifies the therapy as a biologic and, therefore, tests every product batch to ensure quality and consistency measures are met before released for sale.1 – 4
The new labeling also significantly increases the product’s shelf life. Octaplas™ can be stored frozen, ≤-18°C (-0.4°F), for three years from the date of manufacture as opposed to the earlier labeling of two years. Octaplas™ is made from plasma frozen within eight hours of collection in order to preserve labile coagulation factors.1, 2
“This new label is important because medical providers should be aware that once-thawed, Octaplas can be kept refrigerated for up to 24 hours before use,” said Octapharma USA President Flemming Nielsen.
Octaplas™ undergoes multiple manufacturing steps, including plasma pooling, cell filtration and S/D treatment.
“Every batch of Octaplas™ provides a balanced composition of clotting factors, inhibitors and other plasma proteins,” according to Nielsen. “Octaplas™ features a multi-step manufacturing process expressly designed to minimize pathogen transmission and reduce the risk of adverse events such as transfusion related acute lung injury (TRALI), and allergic reactions.” 1 – 4
Between 1992 and the end of 2014, more than 13.5 million bags of Octaplas™ have been transfused to more than 4.5 million patients worldwide across multiple indications without any reported incidences of TRALI during this time. This data includes Octaplas™ predecessor products licensed in Europe as well as S/D-treated plasma products manufactured using the Octapharma process. The number of patients is estimated based on three bags transfused per patient.2
Octaplas™ 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 patients with thrombotic thrombocytopenic purpura (TTP). Please visit www.octaplasus.com for complete product information.
CONTRAINDICATIONS & ADVERSE EVENTS
Octaplas™ [Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion] is contraindicated in patients with immunoglobulin A deficiency; severe deficiency of Protein S; history of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to Octaplas™. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. The most common adverse reactions observed in ≥1% of patients included pruritis, urticaria, nausea, headache and paresthesia.
WARNINGS & PRECAUTIONS
Transfusion reactions can occur with ABO blood group mismatches. High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure. Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin. Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with transfusion rates exceeding 1 mL/kg/min of Octaplas™. Octaplas™ is made from human plasma; therefore, may carry risk of transmitting infectious agents, e.g., viruses, the variant Creutzfelt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell-lines. Octapharma employs approximately 6,000 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com, www.octagamus.net, www.octaplasus.com or www.wilateusa.com.
1. Octaplas™, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion. Complete Prescribing Information. Hoboken, NJ: Octapharma USA; 2015.
2. Octapharma, Data on file. 2015.
3. Bertolini J, Gross N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ; John Wiley & Sons; 2013: chap 25.
4. Hellstern P, Solheim BG. The use of solvent/detergent treatment in pathogen reduction of plasma. Transfus Med Hemother. 2011; 38:65-70.
This news release contains forward-looking statements, which include known and unknown risks, uncertainties, and other factors not under the company’s control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and action by the FDA or other regulatory authorities.
Yankee Public Relations
Fred Feiner, 908-425-4878