Fibryga (fibrinogen concentrate (human)) / Octapharma - LARVOL DELTA

Optimization of Cryoprecipitate Utilization in Cardiac Surgery (ASA 2026) - "We instituted a two-pronged QI project to reduce cryoprecipitate waste through service line education and providing fibrinogen concentrate (Fibryga) as a shelf-stable alternative. Since launch, we've seen a 66.7% average reduction in monthly cryoprecipitate waste."

Surgery • Cardiovascular • Hematological Disorders

Case report: Management of severe hypodysfibrinogenemia in multiple high risk pregnancies in a tertiary haemophilia centre (ISTH 2026) - "Aspirin 150 mg was continued until 26/40 with low-molecular-weight heparin initiated at 28/40...Postpartum she received 12-weeks of enoxaparin alongside Fibryga and tranexamic acid...Given limited guidelines, cases require individualised, adaptable management plans. Table or Figure Upload (1) Page 2 DOI*10.1016/j.rpth.2026.104245"

Case report • Clinical • Cardiovascular • Gynecology • Hematological Disorders • Hemophilia • Mood Disorders • Postpartum Hemorrhage • Rare Diseases • Venous Thromboembolism

STABLE-EMS: Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions (clinicaltrials.gov) - P=N/A | N=2 | Not yet recruiting | Sponsor: Medical University of Graz

New trial • Real-world evidence • Hematological Disorders • Mood Disorders • Thrombosis

The Effect of Fibrinogen Concentrate on Clot Strength in Patients with Congenital and Acquired Fibrinogen Deficiency (THSNA 2026) - "Four Phase 2/Phase 3 trials demonstrated that HFC was effective in increasing clot strength in patients with CFD or AFD, and was hemostatically efficacious and well tolerated. Together with other advantages of HFC over cryoprecipitate, including reduced viral transmission risk, these results advocate the use of HFC in patients with CFD or AFD. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author."

Clinical • Cardiovascular • Thrombosis

Human fibrinogen concentrate Fibryga® enables rapid reversal of thrombolysis and timely repair of acute Stanford type A aortic dissection: a case report. (PubMed, Eur Heart J Case Rep) - "AIS was suspected, and intravenous tenecteplase (TNK) was administered once intracranial haemorrhage was ruled out on non-contrast head computerized tomography (CT) scan. Despite a complicated intra- and post-operative course that included cardiac arrest secondary to rupture and haemopericardium, acute kidney injury, and bowel perforation, the patient was discharged to rehabilitation facility with favourable neurological function. This case illustrates the diagnostic pitfall of ATAAD presenting as stroke and highlights the utility and safety of fibrinogen concentrate (Fibryga®) in rapid reversal of thrombolysis-associated coagulopathy, allowing for safe and timely surgical intervention for ATAAD."

Journal • Acute Kidney Injury • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Hypertension • Ischemic stroke • Nephrology • Renal Disease

Fibrinogen concentrate versus cryoprecipitate for bleeding in cardiac surgery patients stratified by surgery risk in the phase 3 fibres Study (ASH 2025) - P3 | "Moreover, FC was non-inferiorto cryoprecipitate in high-risk surgical patients when excluding the most extreme atypical clinical casescharacterized by catastrophic bleeding and massive transfusion. These findings reinforce the mainoutcomes from the FIBRES study and support the use of FC for management of bleeding in cardiacsurgical patients with acquired hypofibrinogenemia."

Clinical • P3 data • Surgery • Acute Kidney Injury • Anesthesia • Cardiovascular • Renal Disease • Ventricular Tachycardia

Post-Marketing Observational Study of the Safety and Efficacy of Fibrinogen Concentrate in Congenital Fibrinogen Deficiency in Patients of All Ages (ASH 2023) - P | "Results of HFC safety and efficacy will be continually monitored throughout the study. Completion is expected Q4 2027."

Clinical • Observational data • P4 data • Cardiovascular • Hematological Disorders • Pediatrics • Thrombosis

Prophylaxis and Treatment of Bleeding or Thrombosis with Fibrinogen Concentrate (Fibryga) in Patients with Congenital Hypofibrinogenemia or Dysfibrinogenemia (ASH 2023) - "The post procedural bleeding noted in one patient may have been due to inadequate fibrinogen concentration or other comorbid conditions. Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD, especially those with CD."

Clinical • Cardiovascular • Diabetes • Hematological Disorders • Hypertension • Immunology • Metabolic Disorders • Peripheral Arterial Disease • Thrombosis • Type 2 Diabetes Mellitus

A Single Center Approach to Managing Hospitalized Patients with Quantitative Fibrinogen Deficiency That Cost-Saving and Maintains High-Quality, Evidence-Based Care (ASH 2024) - "Guidelines recommend using cryoprecipitate (CP) or fibrinogen concentrates (FC) for replacement. Of the two FC with equal efficacy, using FiB instead of RiA is more cost-saving (36%) to our institution. It highlights the need for a larger study of healthcare utilization and cost-effectiveness analysis paired with measurable outcomes of both FC."

Clinical • HEOR • Cardiovascular • Hematological Disorders • Infectious Disease • Pediatrics

Title: Real-World Utilization of Human Fibrinogen Concentrate in Managing Bleeding in Adult and Pediatric Patients: A Retrospective Study (ASH 2024) - "The existing findings provide justification for the adoption of human fibrinogen concentrate in many clinical scenarios, including both surgical and nonsurgical hemorrhage. The practical benefits and predictable effects of human fibrinogen concentrate in place of standard treatments highlight its potential to not only enhance patient outcomes but also provide for optimized clinical workflows."

Real-world • Real-world evidence • Retrospective data • Hematological Disorders • Hepatology • Mood Disorders • Pediatrics • Postpartum Hemorrhage

CS203. What's New in Perioperative Bleeding Management: Critical Discussion (Non-CME) (ASA 2025) - "Oliver Hegener (Octapharma). This interactive discussion will explore real-world experiences and evidence-based insights on the use of Fibryga (fibrinogen concentrate) in bleeding management, particularly in cardiac surgery."

Cardiovascular

Fibrinogen concentrate versus cryoprecipitate for bleeding in cardiac surgery patients stratified by surgery risk (ASA 2025) - P3 | "In this post-hoc analysis, FC was shown to be superior to cryoprecipitate with regard to number of blood components transfused in patients assessed as moderate surgical risk. This subgroup represents the large majority (greater than 85%) of patients undergoing cardiac surgery and requiring fibrinogen supplementation in the FIBRES study. These findings support the main outcomes from the FIBRES study and support the use of FC for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery."

Clinical • Surgery • Acute Kidney Injury • Cardiovascular • Renal Disease • Ventricular Tachycardia

Evaluating the Use of Human Fibrinogen Concentrate and Cryoprecipitate in Orthotopic Liver Transplantation (ASA 2025) - "In this case series, increased dose of Fibryga was associated with increased cryoprecipitate volume transfusions intraoperatively suggesting higher utilization of cryoprecipitate and other blood products during severe intraoperative coagulopathy may necessitate Fibryga administration as off label use for acquired hypofibrogenemia. Data is limited by single institution experience and small sample size. Further research needed to fully evaluate Fibryga as an adjunct to cryoprecipitate administration in OLT."

Anesthesia • Cardiovascular • Hematological Disorders • Hepatology • Immunology • Liver Failure • Thrombosis • Transplantation

Single Institution Experience Using Intraoperative Human Fibrinogen Concentrate Fibryga in Orthotopic Liver Transplantation - A Case Series (WTC 2025) - "In this case series, human fibrinogen concentrate Fibryga was administered intraoperatively to 16 patients undergoing OLT. High rate of biliary complications may be due to ischemic injury from intraoperative hemodynamic instability. Formal clinical trials must be performed to fully evaluate the safety and effectiveness of Fibryga administration in OLT."

Clinical • Cardiovascular • Hematological Disorders • Hepatology • Liver Failure • Thrombosis • Transplantation

FORMA-07: Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency (clinicaltrials.gov) - P=N/A | N=7 | Terminated | Sponsor: Octapharma | N=25 ➔ 7 | Trial completion date: Oct 2027 ➔ May 2025 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2027 ➔ May 2025; FORMA-07 was initiated as a requirement imposed by the U.S. FDA as part of Octapharma's regulatory obligations. After approving Fibryga for treatment of acquired fibrinogen deficiency in 2024, FDA has agreed that the study may now be discontinued.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

SY105. Beyond the Bleed: Revolutionizing Precision in Hemorrhage Management (non-CME) (ASA 2024) - "Propel your bleeding management practice to new heights! Octapharma, Annual Meeting Supporter"

Cardiovascular • Hematological Disorders • Obstetrics

Cancelled: A Real-World, Retrospective, Observational Study of Fibrinogen Concentrate in Patients With Acute Gastrointestinal Hemorrhage and Fibrinogen Deficiency: Sub-Analysis of the FORMA-10 Study (AABB 2024) - P=N/A | "Among these patients, 17 (81.0%) received concomitant medication, with 6 (35.3%) receiving tranexamic acid. This real-world data shows that FC was successful for on-demand treatment of non‑surgical GI bleeding, with a favorable safety profile. These findings provide valuable insights to aid clinicians in making informed decisions regarding the use of FC for the management of GI bleeding."

Observational data • Real-world • Real-world evidence • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders

Are all fibrinogen concentrates the same? The effects of two fibrinogen therapies in an afibrinogenemic patient and in a fibrinogen deficient plasma model. A clinical and laboratory case report. (PubMed, Front Med (Lausanne)) - "Our report offers insights into the differential effects of these concentrates, at the clot level, according to the variable constituents of each product, thereby emphasizing that the choice of fibrinogen concentrate can influence the stability of a clot in vivo. Whether this alters clinical efficacy is yet to be understood."

Journal • Hematological Disorders • Mood Disorders

PROPHYLACTIC OR POST-TRAUMATIC TREATMENT OF HYPOFIBRINOGENEMIA AND DYSFIBRINOGENEMIA WITH FIBRGYA IN EIGHT CLINICAL CASES (THSNA 2024) - "Methods/ We present eight clinical cases of patients with hypo- or dysfibrinogenemia that were effectively treated with a pooled, plasma-derived fibrinogen concentrate (FIBRYGA) either prophylactically for elective or urgent surgery, or post-traumatic injury. For the majority (86%) of our patients described here with CH and CD, FIBRYGA was well tolerated and effective in preventing post procedural or post traumatic bleeding complications. The post procedural bleeding noted in one patient may have been due to inadequate fibrinogen concentration or other comorbid conditions. Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD."

Clinical • Cardiovascular • Diabetes • Hematological Disorders • Hypertension • Immunology • Metabolic Disorders • Pain • Peripheral Arterial Disease • Type 2 Diabetes Mellitus

Forma-10 sub-analysis: a real-world, retrospective, observational study of fibrinogen concentrate in patients with trauma-related bleeding and fibrinogen deficiency (ISICEM 2024) - "This contemporary, real -life data set indicates that fibrinogen concentrate is successfully used in the management of non -surgical trauma -related bleeding in a European healthcare setting."

Observational data • Real-world • Real-world evidence • Retrospective data • Mood Disorders

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency (clinicaltrials.gov) - P=N/A | N=25 | Recruiting | Sponsor: Octapharma

Trial completion date • Trial primary completion date

Comparison of coagulation parameters associated with fibrinogen concentrate and cryoprecipitate for treatment of bleeding in patients undergoing cytoreductive surgery for pseudomyxoma peritonei: Subanalysis from a randomized, controlled phase 2 study. (PubMed, Health Sci Rep) - "Patients with PE experienced a disproportionate VWF rise following cryoprecipitate administration, whereas patients developing DVT displayed a procoagulant status before and following surgery. Preoperative testing may allow these patients to be identified."

Journal • P2 data • Surgery • Cardiovascular • Hematological Disorders • Pulmonary Embolism • Respiratory Diseases • Thrombosis • Venous Thromboembolism

Differences in coagulation-relevant parameters: Comparing cryoprecipitate and a human fibrinogen concentrate. (PubMed, PLoS One) - "The tested HFC is a more reliable fibrinogen and FXIII source for accurate dosing compared with cryoprecipitate. Cryoprecipitate appears considerably less predictable for bleeding management due to wide variation in pro- and anticoagulation factors, the presence of PMPs, and the potential to elevate VWF and FVIII to prothrombotic levels."

Journal

Management of Dysfibrinogenemia in a Pediatric Patient Undergoing Scoliosis Repair: Case Report (ISTH 2023) - "She received replacement prior to surgery with Human Fibrinogen concentrate, (Fibryga®), with goal fibrinogen activity >150 during the immediate post-operative period...She was started on thromboprophylaxis with enoxaparin 48 hours after surgery, until date of discharge... A 16-year-old female with idiopathic scoliosis was diagnosed with dysfibrinogenemia, after pre-operative testing revealed prolonged PT (19.9 seconds), elevated INR (1.7) and prolonged aPTT (36.6 seconds). Her bleeding score was 3, and her history significant for heavy menstruation and having raccoon eye as a child, after mild scalp trauma. No notable prior thrombotic events or contributory family history."

Clinical • Pediatrics

Real-World Experience with a Human Fibrinogen Concentrate: Clinical Data From Adult and Pediatric Patients Requiring Fibrinogen For Bleeding Control and Prevention. (PubMed, J Clin Pharmacol) - "Fibrinogen concentrate demonstrated favorable effectiveness and safety across age groups. This study contributes to evidence supporting fibrinogen concentrate for bleeding control/prevention in real-world clinical practice, particularly for patients with acquired fibrinogen deficiency."

Clinical data • Journal • Real-world • Real-world evidence • Cardiovascular • Hematological Disorders • Pediatrics • Postpartum Hemorrhage