HOBOKEN, N.J.--(BUSINESS WIRE)--Global health concerns regarding the Zika virus (ZIKV), a flavivirus, have prompted the U.S. Food and Drug Administration (FDA) to issue guidance for blood donation collection, recommending that donors at risk for the virus defer donations for four weeks. The FDA also noted in its guidance that it is unlikely for the virus to be transmitted through fractionated plasma-derived products, such as intravenous immunoglobulin (IVIG) or von Willebrand factor (VWF) and coagulation factor VIII (FVIII) because of existing viral inactivation and removal methods.
“Regarding measures to help prevent ZIKV transmission through blood products, ZIKV is likely cleared by the existing viral inactivation and removal methods that are currently used to clear viruses in the manufacturing processes for plasma-derived products,” the FDA stated. “These methods are highly effective in clearing lipid-enveloped viruses in plasma-derived products, but are not generally applicable for use in blood and blood components intended for transfusion. However, an S/D treated pooled plasma product has been FDA-licensed and is commercially available.”
Octaplas™ [Pooled Plasma (Human), Solvent/Detergent Treated Solution for IV Infusion] is the only FDA-licensed S/D treated pooled plasma product. Octaplas™ goes through the same viral clearance steps as do the fractionated plasma-derived products.
The Plasma Protein Therapeutics Association (PPTA), a trade association of more than 450 human plasma collection centers and manufacturers, has similarly concluded, “PPTA member companies have considerable experience with the capacity of their production processes to effectively eliminate flaviviruses, in case they were present in the plasma. Based on these experiences, Zika virus is not a concern for the safety of plasma protein therapies.”
From its inception, Octapharma has set a very high standard for patient safety and was the first manufacturer to apply the S/D viral inactivation process to production. The company has long applied a selective donor recruitment process to ensure product quality.
“In its guidance, the FDA noted the availability of Octaplas™, a product which further advances Octapharma’s commitment to quality and safety,” said Octapharma USA President Flemming Nielsen. “Octaplas™ undergoes multiple manufacturing steps, including plasma pooling, cell filtration and S/D treatment. The FDA classifies Octaplas™ as a biologic, requiring every product batch of Octaplas™ to be assessed for quality and consistency before release for sale.”1 - 4
The Zika virus, first identified in Africa in 1947, is a flavivirus that is primarily transmitted by infected Aedes mosquitoes, which can also carry dengue, chikungunya, yellow fever and other viruses, according to the World Health Organization (WHO). However, confirmed cases of virus transmission have been reported from mother to child during pregnancy, transfusion of infected blood, and sexual contact.
Until recently, ZIKV was considered a minor illness where 80% of those infected lack symptoms, which are usually mild, including fever, rash, joint pain and conjunctivitis, lasting two to seven days. Concerns have heightened in recent months as ZIKV has been linked, although not scientifically proven to date, to the birth defect microcephaly and a paralyzing autoimmune disorder, Guillain-Barre Syndrome. With no vaccine available and the prospect of large-scale clinical trials 18 months away, WHO has recently recommended that the countries dealing with the virus focus on various tactics to control the massive mosquito population.
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 prescribing 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.
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.