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Patient blood management strategies have become increasingly important during the COVID-19 pandemic as the medical community has confronted the effects of decreasing blood supply. In fact, the American Red Cross recently declared the nation’s first-ever national blood crisis with the omicron variant surge, placing ever greater demands on blood product supply nationwide.1 This press release features multimedia. View the full release here: As omicron has spread nationally, Octapharma’s fibryga® and Octaplas™ have become Increasingly important replacement therapies. (Photo: Business Wire) Medical providers should consider replacing cryoprecipitate and fresh frozen plasma with Octapharma USA’s Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution. In addressing the tightening supply of blood products, the College of American Pathologists TACT (Transfusion, Apheresis, and Cellular Therapy) Committee has recommended that hospital transfusion services consider replacing products such as cryoprecipitate, if supplies become depleted, with alternative human plasma products.2 Octaplas™ and fibryga® are in good supply and readily available. “The current blood shortage has created a need to utilize alternatives for plasma and cryoprecipitate, such as Octaplas™ and fibryga®,” said Melissa Cushing, M.D., an international expert in perioperative bleeding and patient blood management.3 “I have utilized a proactive approach to patient blood management that includes using these products to replace plasma and cryoprecipitate, as well as strict enforcement of transfusion guidelines and hosting blood drives.” Many factors can impact the blood products supply chain, such as the number of donors, seasonal factors, and the ability of blood services to adequately predict needs throughout the year.4 Awareness of appropriate blood products ordering can help clinicians manage supply chain disruptions. “The availability of Octapharma’s human plasma products affords our critical care partners the confidence to support patient needs,” said Octapharma USA President Flemming Nielsen. “At Octapharma, critical care medicine continues to be an important part of our therapeutic focus − and we are fully committed to supporting our healthcare partners with a reliable and sustainable product supply.” About fibryga® Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use, is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga® is not indicated for dysfibrinogenemia. Contraindications Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga® or its components. Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving fibryga®. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. Fibryga® is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Events The most serious adverse reactions that may be observed with fibryga® are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with fibryga® (>5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis. About Octaplas™ Octaplas™ is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP). Contraindications Octaplas™ is contraindicated in patients with immunoglobulin A (IgA) deficiency; severe deficiency of protein S; history of hypersensitivity to fresh frozen plasma or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to Octaplas™. Warnings and Precautions Transfusion reactions can occur with ABO blood group mismatches. Administration of Octaplas™ must be based on ABO-blood group compatibility. 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 (also named plasmin inhibitor). Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas™ per kg per minute. Octaplas™ is made from human plasma and may carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Reactions The most common adverse reactions observed in ≥ 1% of patients included pruritus, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. 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 more than 10,000 people worldwide to support the treatment of patients in over 115 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 Paramus, N.J. Octapharma operates three 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 octapharmausa.com. REFERENCES 1 - Red Cross Declares First-ever Blood Crisis amid Omicron Surge, January 11, 2022. 2 - The College of American Pathologists. The coronavirus emergency and the US blood supply: College of American Pathologists Transfusion, Apheresis and Cellular Therapy Committee. March 27, 2020. 3 - Melissa Cushing, M.D. is a paid consultant for Octapharma. 4 - Jan Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60:2748–2752.

Recently added to the BioPortfolio report store, 2016 Japanese Coagulation Testing Market: Growth Opportunities and Business Expansion Strategies for Instrument and Reagent Suppliers is a new report from VPG MarketResearch published on 2015-10-15. This 402-page report is available from $4800. Complete report $7,400. DataPack (test volumes, sales forecasts, supplier shares) $4,800. Summary This comprehensive report contains 402 pages, 35 tables, and is designed to help current suppliers and potential market entrants identify and evaluate business opportunities emerging in the Japanese coagulation testing market during the next five years. The report explores business and technological trends in the Japanese coagulation testing market; provides estimates of the test volume, as well as sales and market shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years. Coagulation Tests Activated Clotting Time (ACT) (1), Activated Protein C Resistance, Activated PTT (APTT), Alpha 2-Antiplasmin, Antithrombin III, Bleeding Time, D-Dimer, Factor II, Factor V, Factor V Leiden, Factor VII, Factor VIII, Factor IX, Factor Ixa, Factor X (Stuart Factor), Factor Xa, Factor XI, Factor XII, Factor XIII, Fibrin Degradation Products, Fibrinogen, Fletcher Factor/Pre-Kallikrein Factor Activation, Heparin/Anti-Factor Xa, Heparin-Induced Thrombocytopenia, Plasmin, Plasminogen, Plasminogen Activator Inhib., Platelet Function/Aggregation, Protein C, Protein S, Prothrombin Mutation, Prothrombin Time (PT), Reptilase Time, Thrombin Time, Von Willebrand's Factor Fav/Ag, and others. Sales and Market Share Analysis - Sales and market shares of major instrument and reagent suppliers. Competitive Assessments - Extensive strategic profiles of major suppliers and emerging market entrants. Market Segmentation Analysis - Comprehensive market segmentation analysis, including: - Hospitals - Commercial/Private Laboratories - Test volume forecasts for over 40 major procedures by market segment. Current and Emerging Products - Review of established and emerging procedures. - Comparison of automated and semi-automated analyzers from Diagnostica Stago, Helena, IL, Siemens, Sysmex and other suppliers. Technology Review - Analysis of current and emerging technologies and their potential market applications. - Comprehensive lists of companies developing or marketing new technologies and products by test. Strategic Recommendations - Product development and business expansion opportunities with significant market appeal. - “Ideal” product models with tentative prices and operating characteristics. - Alternative market penetration strategies for instrument and reagent suppliers.