NovoSeven (eptacog alfa) / Novo Nordisk - LARVOL DELTA

Unexplained bleeding and a hidden inhibitor: A case of late-onset acquired hemophilia A (ASH 2025) - "The patient was treated initially with recombinant porcine Factor VIII (Obizur) without sustained response, then switched to recombinant activated Factor VII (NovoSeven) for hemostasis. Immunosuppressive therapy with prednisone and rituximab was initiated... AHA should be considered in elderly patients with unexplained bleeding and isolated prolonged aPTT, even following trauma. Increased awareness and timely intervention can significantly improve outcomes in this rare but potentially fatal disorder."

Clinical • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Diabetic Nephropathy • Hemophilia • Hemophilia A • Hypertension • Immunology • Ischemic stroke • Metabolic Disorders • Nephrology • Rare Diseases • Renal Disease • Type 2 Diabetes Mellitus

Evaluating reversal strategies for long-acting factor XI antibodies: RFVIIa®, FEIBA®, Kcentra®, novel FXI mutants, and an anti-idiotypic antibody (ASH 2025) - "BAY1831865), and theactive site binding FXIa inhibitor osocimab...With contact activation (ellagic acid or kaolin), the relative potency of thrombin inhibitionshifted: AB011 again showed the strongest inhibition on par with FXI-/- plasma, followed by gruticibart,and osocimab... FXI inhibitors produce anticoagulant effects across global coagulation assays that can bepartially or completely reversed by bypassing agents, particularly NovoSeven® and FEIBA®; however PT,TGA and viscoelastic testing also reveal the potential to generate a transient procoagulant/prothromboticstate if plasma concentrations of these commercially available agents are too high. The magnitude of theprocoagulant activity is dependent on the bypassing agent as well as the specific FXI inhibitor, suggestingthat reversal strategies should be tailored to the mechanism of the different FXI inhibitors (i.e. A2, A3, orcatalytic domain) to achieve optimal outcomes."

Hematological Disorders • Hemophilia • Rare Diseases

The Mayo Clinic enterprise experience and outcomes of perioperative utilization of recombinant factor VIIa (rFVIIa, NovoSeven®) (ASH 2025) - "Adjunctive medications to control bleeding included emicizumab, FEIBA, and rituximab.Mean estimated blood loss was 136 mL (SD 211 mL), and mean length of stay was 5.7 days (SD 6.4).Surgical risk strongly correlated with perioperative outcomes: blood loss increased from 19 mL in verylow-risk surgeries to 352 mL in very high-risk surgeries, while mean length of stay increased from 4.5days (risk 1) to 19 days (risk 4) and 11 days (risk 5).Actual rFVIIa dosing ranged from 7.2 to 7211.5 mcg/kg per dose, with a median of 67.4 mcg/kg and amean of 852.8 mcg/kg, reflecting variability in clinical practice. In conclusion, perioperative rFVIIa was most frequently used for Factor VII deficiency but was alsoadministered to patients with Factor VIII inhibitor and Glanzmann's thrombasthenia, as well as severalrare congenital and acquired bleeding disorders. Postoperative thrombotic events were rare, while ISTH-defined bleeding complications and readmissions were common. Most..."

Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Acquired Hemophilia A (AHA) associated with monoclonal gammopathy: A single institution case series (ASH 2025) - "Bleeding resolved with Novoseven, corticosteroids, and weekly Rituximab.He was transitioned to Hemlibra, completed 4 doses of Rituximab and tapered off with completeresolution of the inhibitor.Case 3:An 80-year-old female with IgG lambda MGUS presented with a spontaneous and enlarging left upperthigh hematoma with active extravasation, requiring IR guided embolization and multiple units of bloodtransfusions. This suggests that even minimal clonal plasma cell activity,characteristic of MGUS, can cause significant immune dysregulation leading to severe autoimmunecomplications like AHA.Although MGUS typically requires no treatment, persistent or refractory bleeding with sustained inhibitorlevels may warrant myeloma directed therapy targeting the plasma cell clone. Hence further awarenessabout of this novel association could also inform the treatment strategies in patients not responding toinitial measures."

Clinical • Beta-Thalassemia • Hematological Malignancies • Hemophilia • Hemophilia A • Immunology • Monoclonal Gammopathy • Multiple Myeloma • Rare Diseases • Smoldering Multiple Myeloma

In vitro comparison of eptacog beta and eptacog alfa with antithrombin lowering (simulated fitusiran) using thrombin generation assay (ASH 2025) - "These results demonstrate that in vitro both eptacog beta and eptacog alfa similarly increase TG when ATlevels are reduced to fitusiran target ranges. Eptacog alfa doses of 45µg/kg, used to treat bleeds inpatients on fitusiran, had similar TG parameters to the 75µg/kg and 125µg/kg doses of eptacog beta. Thisdata provides in vitro proof of concept supporting the use of eptacog beta for the treatment ofbreakthrough bleeds of patients on fitusiran prophylaxis."

Preclinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Real World Experience with use of Coagulation Factor VIIa at an Academic Medical Center. (PubMed, Clin Appl Thromb Hemost) - "Our institution converted from eptacog alfa to eptacog beta as the preferred rFVIIa product. Cost avoidance was estimated at $554,400 over a 12-month period.ConclusionWe treated a small cohort of patients with eptacog beta without adverse outcomes. Other hospitals might evaluate their rFVIIa use and consider opportunities for substitution."

Journal • Real-world evidence • Retrospective data • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • Thrombosis

Real-World Experience with Eptacog Beta for On-Label and Off-Label Indications: The Spanish Experience. (PubMed, Pharmaceuticals (Basel)) - "Preclinical studies have shown the product has a similar profile to eptacog alfa. Our experience provides further evidence of the efficacy and safety of eptacog beta for surgical prophylaxis and treatment of bleeding in patients with haemophilia A with inhibitors, but also in those with factor VII deficiency. To our knowledge, this is the first report to describe the use of eptacog beta for factor VII deficiency and acquired haemophilia."

Journal • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Recombinant Factor VIIa Prophylaxis in 2 Brothers with Bernard-Soulier Syndrome. (PubMed, Am J Case Rep) - "Recombinant activated factor VIIa (rFVIIa, trade name: NovoSeven) has emerged as a potential alternative therapy...The older brother, aged 19, presented with persistent gingival bleeding that was unresponsive to tranexamic acid and required hospital-based interventions, including platelet transfusions...This case highlights the potential role of rFVIIa as a viable alternative to platelet transfusions in patients with recurrent bleeding. Further studies are needed to establish standardized protocols for prophylactic rFVIIa use in BSS."

Journal • Hematological Disorders • Thrombocytopenia

Cost-Savings Analysis of Fitusiran Prophylaxis: Reducing Breakthrough Bleeding Treatment Expenditure in the Kingdom of Saudi Arabia (ISPOR-EU 2025) - P3 | "For people with haemophilia (PwH) A without inhibitors, episodic treatments comprised octocog alfa, efmoroctocog alfa and rurioctocog alfa pegol for PwH A and nonacog alfa, albutrepenonacog alfa and eftrenonacog alfa for PwH B. Treatments included for PwH with inhibitors were factor VIII inhibitor bypassing activity (FEIBA) and eptacog alfa. In the KSA, fitusiran AT-DR prophylaxis may considerably reduce breakthrough bleed management costs in PwH versus CFC/BPA prophylaxis. Cost savings are predicted to be more substantial in PwH with inhibitors than in those without inhibitors."

HEOR • Hematological Disorders • Hemophilia • Rare Diseases

FASTEST Part 2: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2 (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Joseph Broderick, MD

New P3 trial • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Transplacental Transfer of Emicizumab: Experience with Emicizumab in a Pregnant Female with Severe Hemophilia Α and an Inhibitor (ASH 2023) - "She was not treated with immune tolerance induction and had remained on factor eight inhibitor bypassing activity (FEIBA) as prophylaxis until transferring to our center. She was transitioned to monthly emi prophylaxis and recombinant FVIIa (rFVIIa, NovoSeven) for breakthrough bleeding at age 26...Her labor was induced with oxytocin while on rFVIIa and tranexamic acid (TXA) support... In this highly unusual case, we demonstrate that emi crossed the placenta and is excreted in breast milk. We also demonstrate that the maternal FVIII inhibitor did not cross the placenta into the newborn. Drawing conclusions on the safety of emi despite placental and breast milk transmission and transmissibility of inhibitor based on a single case would be premature."

Hematological Disorders • Hemophilia • Hemophilia A • Postpartum Hemorrhage • Rare Diseases

The Influence of Coagulation Factor Biosimilars in Shortening the Activated Partial Thromboplastin Time in Patients with Hemophilia a (ASH 2024) - "Negative correlation was observed between PT and FVII values after adding Kogenate FS (r=-0.103, p<0.001), aPTT and FVIII values after adding Kogenate FS (r=-0.898, p<0.001), aPTT and FVIII values after adding NovoEight (r=-0.865, p<0.001), as well as aPTT and FVIII values after adding AryoSeven (r=-0.647, p<0.001).Conclusion : All the investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII. In terms of efficacy, no difference exists between AryoSeven and NovoSeven, as well as between Kogenate FS and NovoEight only in altering PT."

Clinical • Genetic Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Mood Disorders • Rare Diseases

Cost-Savings Assessment of Fitusiran Prophylaxis in Minimizing Breakthrough Bleeding Treatment Expenses in the United Arab Emirates (ISPOR-EU 2025) - P3 | "The episodic treatments included were efmoroctocog alfa, octocog alfa and rurioctocog alfa pegol for people with haemophilia (PwH) A without inhibitors and albutrepenonacog alfa, nonacog alfa and eftrenonacog alfa for PwH B without inhibitors...A scenario analysis examined the impact of vial sharing. Among PwH without inhibitors, fitusiran AT-DR enabled per-bleed savings ranging from UAE Dirham (AED) 4,625 (efmoroctocog alfa) to AED 11,521 (rurioctocog alfa pegol) in PwH A and from AED 8,935 (nonacog alfa) to AED 30,053 (albutrepenonacog alfa) in PwH B. In PwH with inhibitors, fitusiran AT-DR usage generated per-bleed savings of AED 71,846 (FEIBA) to AED 90,761 (eptacog alfa). In the UAE, fitusiran AT-DR prophylaxis may considerably reduce costs associated with episodic treatments for breakthrough bleeds in PwH compared with CFC/BPA prophylaxis. PwH with inhibitors might have larger cost savings than those without inhibitors."

HEOR • Hematological Disorders • Hemophilia • Rare Diseases

A Single Center Experience of 13 Episodes of Acquired Hemophilia A (2019 - 2023) (ASH 2023) - "The use of aPCC (FEIBA) instead of rFVIIa (NovoSeven) as the first-line BPA led to total estimated cost avoidance of $13. We describe 13 episodes of AHA successfully treated at a single academic medical center between 2019 and 2023. aPCC was the first-line BPA administered in all patients, with significant cost savings relative to rFVIIa. Immunosuppression, including prednisone and either cyclophosphamide or rituximab, was used to successfully eliminate autoantibodies in all patients."

Clinical • Hemophilia • Hemophilia A • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Rare Diseases • Respiratory Diseases

A TARDY PRESENTATION OF ACQUIRED HEMOPHILIA A (CHEST 2025) - "Novoseven was infused at 4000mcg (70-90 mcg/kg/dose) every 2-3 hours until bleeding was controlled in adjunct with methylprednisolone 125mg and eventual oral prednisone 40mg taper...Subsequent weekly immunosuppressant therapy (IST) with Rituximab, a chimeric monoclonal antibody targeting the autoimmune mediated inhibitors, was initiated for a total of 8 weeks... Although incidence in an advanced age group is low [1], AHA requires prompt testing, diagnosis, treatment and avoidance of triggering or inciting events of bleeding."

Anemia • Breast Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hemophilia • Hemophilia A • Hypertension • Immunology • Rare Diseases • Rheumatology • Solid Tumor

CHARACTERIZATION OF THROMBOEMBOLIC EVENTS AFTER RECOMBINANT COAGULATION FACTOR VIIa (rFVIIa - NOVOSEVEN®) USE IN CARDIAC SURGERY: A DESCRIPTIVE PILOT STUDY. (PubMed, Ann Pharm Fr) - "Our study allowed us to describe the use of rFVIIa in massive bleeding in cardiac surgery. The average total dose of rFVIIa administered was higher in patients with thromboembolic events than in those who did not. A more robust study will be conducted to investigate the attributability of rFVIIa to the occurrence of postoperative thromboembolic events."

Journal • Cardiovascular • Hematological Disorders

Anesthetic Management of a PVC Ablation Complicated by Pericardial Tamponade and Subsequent Embolic Stroke (ASA 2025) - "Coagulopathy was treated with Kcentra, FFP, TXA, NovoSeven, and platelets to reverse anticoagulant effects and restore hemostasis. Given persistent neurological decline, extubation was delayed, prompting neuroimaging that revealed multiple acute strokes. Multimodal resuscitation and coagulation management were critical in stabilizing this patient for postoperative neurological assessment."

Anesthesia • Cardiovascular • CNS Disorders • Dyslipidemia • Hematological Disorders • Hypertension • Ischemic stroke • Multiple Sclerosis

Electroconvulsive Therapy (ECT) for a Patient with Hemophilia A (ASA 2025) - "To decrease bleeding risk, hematology service recommended NovoSeven (recombinant Factor VIIa) 1 mg IV 10-15 minutes prior to each ECT session. Anesthetic considerations and successful management of patients with life-threatening coagulopathy requiring ECT are discussed."

Clinical • Anesthesia • CNS Disorders • Depression • Hematological Disorders • Hemophilia • Hemophilia A • Psychiatry • Rare Diseases

A Case of Massive Bleeding Requiring NovoSevenⓇ Administration during Thoracic Surgery in a Patient with Undiagnosed Acquired Hemophilia. (ASA 2025) - "He was ultimately diagnosed with acquired hemophilia postoperatively. Among patients presenting with a sudden onset of prolonged APTT, some have acquired hemophilia, and NovoSeven is effective in achieving hemostasis in these cases."

Clinical • Surgery • Hematological Disorders • Hemophilia • Rare Diseases

A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India (clinicaltrials.gov) - P4 | N=64 | Recruiting | Sponsor: Novo Nordisk A/S

New P4 trial • Postpartum Hemorrhage

Outcomes of recombinant activated factor VIIa (NovoSeven) therapy in glanzmann thrombasthenia: two case reports. (PubMed, Blood Coagul Fibrinolysis) - "Both patients demonstrated reduced bleeding frequency and improved quality of life without thromboembolic complications. These cases underscore the therapeutic potential and safety of rFVIIa in managing bleeding episodes and preventing alloimmunization in GT, particularly when platelet transfusions are ineffective or contraindicated, and highlight the importance of individualized treatment approaches and the need for further research to refine prophylactic regimens in GT."

Journal • Cardiovascular • Hematological Disorders • Pediatrics

GLANZMANN THROMBASTHENIA AND VENOUS THROMBOSIS : ABOUT 2 CASES (EHA 2025) - "In January 2023, he was admitted for the third episode of melena associated with severe anemia (hemoglobin drop to 5 g/dl) resistant to platelet and red cell transfusions, and continuous infusion of Esomeprazole. This situation necessitated four injections of Novoseven at a dose of 6 mg twice daily for four days, which successfully stopped the bleeding...In 2007, thrombophlebitis of the right lower limb was discovered, and treated with anti-vitamin K (Sintrom*), which was stopped after five months due to recurrent hemorrhagic syndrome and thrombosis permeability... Those observations showed that a severe thrombotic process may occur even in GT.The occurrence of venous thrombosis in our cases is due to the injection of recombinant factor VIIa and the central catheter in one case, and estrogen-progestogen therapy in the second case. The use of unfractionated heparin and low-molecular-weight heparin in the 1st case remains the treatment of choice while the role of new oral..."

Clinical • Anemia • Cardiovascular • Gastroenterology • Hematological Disorders • Pain • Pulmonary Embolism • Respiratory Diseases • Thrombosis

COAGULATION FACTOR DEFICIENCIES: AN OVERVIEW OF A SINGLE CENTER (EHA 2025) - "Hemorrhagic complications in Factor VII deficiency required simple monitoring in 84.6%, the use of Factor VII recombinant (Novoseven) in 7.7% and PPSB in 7.7%... Coagulation factor deficiencies represent a diverse group of bleeding disorders with varying clinical manifestations depending on the factor involved. Understanding the biological and clinical features, and management of these conditions is crucial for effective diagnosis and treatment."

Clinical • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Osteoarthritis • Rare Diseases • Thrombosis

PHASE I AND III STUDY RESULTS OF RECOMBINANT HUMAN COAGULATION FACTOR VIIA (TQG203):PHARMACOKINETICS/PHARMACODYNAMICS,EFFICACY AND SAFETY OF TQG203 IN HEMOPHILIA PATIENTS WITH INHIBITORS (EHA 2025) - "Aims: Phase I (TQG203-I-01) and Phase III (TQG203-III-01) studies were designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of TQG203 in patients with congenital hemophilia A or B. The TQG203-I-01 study assessed the pharmacokinetics and pharmacodynamics (PK/PD) of TQG203 in hemophilia patients with inhibitors, comparing it to Novoseven® to establish dosing for the Phase III trial... TQG203 demonstrated a rapid onset of action and pronounced hemostatic efficacy in inhibitor-positive hemophilia A or B patients, with a good safety profile. Its straightforward administration allows for convenient home treatment. This enables a larger population of inhibitor-positive hemophilia A or B patients to experience clinical benefits from the therapy."

Clinical • P1 data • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Enoxaparine and Novoseven can be monitorerd by ROTEM during lung transplantation with ECMO support (ISTH 2025) - "See Figures 1 and 2 for details. Table or Figure Upload"

Cardiovascular • Hematological Disorders • Thrombosis • Transplantation