Fibrinogen (Human)(Octapharma)

Critical Care Product Portfolio to be Highlighted During American Society of Anesthesiologists Medical Congress in San Francisco PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco. The symposium will address current gaps in research related to factor concentrates, including prothrombin complex concentrates (PCC) and fibrinogen concentrates (FC), for perioperative bleeding management. Continue Reading Perioperative coagulopathic bleeding is an important driver of morbidity & mortality in patients during major surgery. Tweet this Kamrouz Ghadimi, MD, MHSc, Department of Anesthesiology, Duke University, will discuss, "Perioperative Coagulopathic Bleeding – Definition, Treatment Algorithms, and POC Testing, Oh My!" Keyvan Karkouti, MD, Department of Anesthesiology, Toronto General Hospital, will discuss, "What's New in Research with PCC and Fibrinogen Concentrates in Surgery?" The presenters will review the role of PCC and FC in surgical patients and discuss best practices for bleeding management. As global practices in coagulation factor replacement for perioperative bleeding vary, the presenters will review recently published data, guidelines, ongoing studies, and strategies to help standardize bleeding management. The symposium will explore: The role of factor concentrates and blood products for management of bleeding in surgery; The latest research and current practice guidelines for factor concentrates in perioperative bleeding; and Individualized bleeding management strategies in cardiac surgery, with patient case presentations. "Perioperative coagulopathic bleeding is an important driver of morbidity and mortality in patients undergoing major surgery," said Dr. Ghadimi, one of the symposium presenters. "Over the past decade, the use of hemostasis algorithms that utilize factor concentrates has emerged as a key strategy to reduce transfusion burden in these patients." The educational breakfast symposium will be offered to ASA attendees October 15 at 6:30 am PST. To register, please visit connect.octapharmausa.com/events/asa23/index.html. "We look forward to presenting this important symposium in conjunction with the ASA Annual Meeting and connecting with the healthcare community to advance critical care medicine," said Octapharma USA President Flemming Nielsen. "Octapharma is committed to providing patients with life-saving and life-enhancing therapies for critical care medicine. Our team will be on hand during ASA to share the latest developments in the Octapharma critical care product portfolio." In July, Octapharma received U.S. Food and Drug Administration (FDA) approval for Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. The Octapharma USA critical care portfolio also includes fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, a therapy indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. The Octapharma critical care booth (#461) at ASA will provide attendees with information on the full product portfolio. The ASA Annual Meeting will be held October 13 – 17 at San Francisco's Moscone Center. For more information, please visit asahq.org/annualmeeting. About Balfaxar® Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events. Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months. For complete boxed warning and full prescribing information, please visit Balfaxar.com. 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. For complete prescribing information, please visit fibrygausa.com/pi. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. BALF-0111-PPR SOURCE Octapharma

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.