Acquired coagulation factor deficiency

Octapharma is Committed to Supplying Hospitals and Medical Providers with New Prothrombin Complex Concentrate PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is 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 urgent surgery or invasive procedures. Continue Reading Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers. Post this Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro®. "The availability of Balfaxar® brings a welcome new treatment option for medical providers around the country," said Josh Goldstein, MD, PhD, Professor of Emergency Medicine at Harvard Medical School and Massachusetts General Hospital. "More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming in patients who are at high risk.1 Unfortunately, the main side effect of warfarin is an increased risk of bleeding, which can complicate urgent surgery or invasive procedures.2 Clinical research has demonstrated that Balfaxar® is extremely effective in restoring blood coagulation by replenishing the levels of clotting factors that are deficient in those patients on warfarin." Balfaxar® is a non-activated 4F-PCC containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. "We are excited to announce the availability of Balfaxar® and are committed to providing the medical community with a valuable life-saving therapy," said Octapharma USA President Flemming Nielsen. "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future. We look forward to working with our critical care medicine partners to ensure patients receive the absolute best treatments available." The FDA approval of Balfaxar® was supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103). Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk. The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results. Balfaxar® demonstrated effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra®. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.3 To study Balfaxar® further in other clinical scenarios, Octapharma is recruiting for two additional Phase III studies: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (ClinicalTrials.gov Identifier: NCT04867837) LEX-211: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (ClinicalTrials.gov Identifier: NCT05523297) For more information on LEX-210 and LEX-211, please visit ClinicalTrials.gov. Kcentra® is a registered trademark of CSL Behring GmbH. For more information on Balfaxar®, please contact Octapharma customer service at 201-604-1130. 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/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. REFERENCES 1 - ClinCalc.com, Warfarin: Drug Usage Statistics, United States, 2013 - 2020, accessed June 19, 2023. 2 - Mayo Clinic, Warfarin side effects: Watch for interactions, accessed June 19, 2023. 3 - Ravi Sarode, Joshua N. Goldstein, Gregory Simonian, Truman J. Milling Jr; A Phase 3, Prospective, Randomized, Double-Blind, Multicenter, Non-Inferiority Study Comparing Two Four-Factor Prothrombin Complex Concentrates for Reversal of Vitamin K Antagonist-Induced Anticoagulation in Patients Needing Urgent Surgery with Significant Bleeding Risk. Blood 2022; 140 (Supplement 1): 352–353. doi: SOURCE 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

Balfaxar, a non-activated four-factor prothrombin complex concentrate (4F-PCC) that contains vitamin K-dependent factors, Factor II, Factor VII, Factor IX and Factor X, is offered with sterile water for injection and new transfer device nextaro Octapharma secures FDA approval for Balfaxar. (Credit: ANIRUDH on Unsplash) Octapharma has received the US Food and Drug Administration (FDA) approval for Balfaxar (prothrombin complex concentrate, human-lans), marketed as octaplex in Europe and Canada. Balfaxar is a blood coagulation factor replacement product, indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adults with the need for urgent surgery or invasive procedures. It is a non-activated four-factor prothrombin complex concentrate (4F-PCC) that contains vitamin K-dependent factors, Factor II (prothrombin), Factor VII, Factor IX and Factor X, along with antithrombotic Proteins C and S. Octapharma is offering the lyophilised powder that restores the levels of clotting factors deficient due to warfarin therapy, with sterile water for injection and the new transfer device, nextaro. The nextaro transfer device includes an optimised vial housing that enables precentering of the vial during mounting, and optimised contamination protection with two integrated filters. Octapharma said that healthcare professionals preferred nextaro device compared to a widely used competitive transfer device, in a user preference study. Octapharma president Flemming Nielsen said: “The FDA approval of Balfaxar establishes a new therapy for medical providers when their patients need a 4F-PCC product. “Octapharma is committed to providing patients with life-saving and life-enhancing therapies for critical care medicine. We are confident Balfaxar will be a welcomed treatment for physicians who need to quickly restore patients’ coagulation.” The FDA approval is supported by the LEX-209 clinical trial, which compared the efficacy and safety of Balfaxar compared to a control 4F-PCC (Kcentra), at 24 sites in the US and Europe. In Phase 3, randomised, double-blind, multicentre study, 208 patients were randomised to receive either Balfaxar or control 4F-PCC. Octapharma is recruiting for two additional Phase 3 studies of Balfaxar, LEX-210 and LEX-211. LEX-210 will evaluate OCTAPLEX in patients with acute major bleeding on DOAC therapy. LEX-211 will compare the 4-factor prothrombin complex with frozen plasma in cardiac surgery. LEX-209 principal investigator Ravi Sarode said: “Balfaxar met the primary endpoint of haemostatic efficacy and was non-inferior to the comparator, Kcentra, in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk. “The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results indicating that Balfaxar was non-inferior to Kcentra. “International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety pro similar between treatment arms and consistent with previous studies.”