NovoSeven (eptacog alfa) / Novo Nordisk - LARVOL DELTA

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 | Trial completion date: Mar 2027 ➔ Aug 2027 | Trial primary completion date: Mar 2027 ➔ Aug 2027

Trial completion date • Trial primary completion date • Postpartum Hemorrhage

Spontaneous CSF rhinorrhoea in a patient with factor VII deficiency: surgical and haematological considerations. (PubMed, BMJ Case Rep) - "To optimise safety before imaging, the patient received intravenous recombinant factor VII (NovoSeven, Eptacog alfa), after which CT cisternography demonstrated a persistent CSF leak from the cribriform plate...This case underscores the challenges of balancing haemostatic control during surgical intervention in patients with rare bleeding disorders. Notably, no prior reports in the literature describe CSF rhinorrhoea occurring in the setting of factor VII deficiency, making this presentation unique."

Journal • Hematological Disorders • Otorhinolaryngology

Evaluation of Commercially Available Bypassing Strategies for Long-Acting Factor XI Antibodies (ISTH 2026) - "Methods Bypass of gruticibart (AB023 A2 ), AB011 A3 , and osocimab was tested using commercially available bypass agents NovoSeven® (recombinant factor VIIa), FEIBA® (activated PCC), and Kcentra® (non-activated PCC). Together, these findings suggest that FXI-directed anticoagulation may be clinically manageable with commercially available bypassing agents used at carefully controlled doses. DOI*10.1016/j.rpth.2026.105554"

Long-term experience with emicizumab in people with hemophilia A in the Canadian Bleeding Disorders Registry. (PubMed, Blood Adv) - "During the observational period, the safety profile was in keeping with previous reports; 34 adverse events were observed, including two thrombotic events (one unlikely related to emicizumab; one probably related to previous use of eptacog alfa and/or possibly related to previous emicizumab, and associated with a central venous access device). A notable decrease in bleeds and sustained bleed control were observed in this population for up to a 5-year follow-up period. Continued follow-up will allow for greater quantification of this impact over time, providing valuable information to healthcare practitioners and regulatory authorities."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Experience with acquired Hemophilia A: a 5-year audit at a tertiary care center in North India (ISTH 2026) - "Immunosuppressive therapy (IST): Two patients were treated with prednisolone, while multiple agents were used in patients with high-titer inhibitors, including steroids + cyclophosphamide in 4 cases and steroids + rituximab ± cyclophosphamide in 4 cases (Table 1). For bleed control, most patients could be treated with only tranexemic acid, one received Novoseven, and one was given emicizumab prophylaxis...Despite the hurdles, the CR rate is comparable to that reported in the literature. Table or Figure Upload (1) Table 1: Patient profile of 10 Acquired Hemophilia A cases Page 2 DOI*10.1016/j.rpth.2026.104759"

Hematological Disorders • Hemophilia • Hemophilia A • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Osteoarthritis • Rare Diseases • Rheumatoid Arthritis

Cerebral Hemorrhage in Type I Glanzmann Thrombasthenia: Case Series (ISTH 2026) - "All bleeding episodes were provoked: two followed minor head trauma, one occurred postoperatively (meningioma resection), and one was iatrogenic, following aspirin administration for ischemic stroke management...Hemostatic management relied on administration of recombinant activated factor VII (rFVIIa, NovoSeven®), platelet concentrates and use of tranexamic acid...The establishment of a dedicated prospective registry would enable the collection of reliable data on the treatment of cerebral hemorrhage in type I Glanzmann thrombasthenia. Page 2 DOI*10.1016/j.rpth.2026.106164"

Clinical • Brain Cancer • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Hemophilia • Ischemic stroke • Meningioma • Rare Diseases • Renal Disease • Solid Tumor • Subarachnoid Hemorrhage

Preclinical Safety and Thrombotic Risk Assessment of the siRNA TGM-148 for Bleeding Disorders (ISTH 2026) - "mTGM- 148 was co-administered with standard factor replacement therapies (Advate, BeneFIX) or bypassing agents (NovoSeven, FEIBA), with measurement of D-dimer levels. TGM-148 is advancing toward CTA submission in 2026. DOI*10.1016/j.rpth.2026.104873"

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

Refractory Hemorrhage Following Total Knee Replacement Unmasking Acquired Hemophilia A. (PubMed, Cureus) - "Hemostasis was achieved following treatment with FEIBA and NovoSeven under hematology guidance. This case highlights acquired hemophilia A as a rare but important differential diagnosis in persistent postoperative bleeding following total knee replacement. Early recognition, prompt coagulation workup, and multidisciplinary management are essential to improve outcomes."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Musculoskeletal Diseases • Orthopedics • Pain • Rare Diseases • Rheumatology

Case Report: Life-threatening pulmonary haemorrhage following hybrid VSD closure and pulmonary artery de-banding: major aortopulmonary collaterals as a hidden danger. (PubMed, Front Cardiovasc Med) - "Post-procedurally, she developed massive PH, partially controlled with endotracheal adrenalin, tranexamic acid and NovoSeven®. Clinicians should be highly vigilant for MAPCAs in patients experiencing massive pulmonary haemorrhage following pulmonary artery debanding. This case underscores the importance of preoperative screening for MAPCAs in infants undergoing staged repairs for coarctation and VSD, particularly when pulmonary artery banding appears successful, and oxygen saturation appears normal."

Journal • Fatigue

SUCCESSFUL HEMODIALYSIS INITIATION IN ACQUIRED HEMOPHILIA A MANAGED WITH SUSOCTOCOG ALFA AND EMICIZUMAB (ISN-WCN 2026) - "Hemostatic therapy was prioritized to safely continue HD.Results Initial hemostasis with recombinant activated factor VII (rFVIIa; eptacog alfa) was insufficient. To our knowledge, this is the first report documenting HD initiation and maintenance in AHA using the sequential susoctocog alfa followed by emicizumab. This case highlights an infection-conscious practical strategy for frail patients-prioritizing rapid procedural hemostasis with rpFVIII when rFVIIa response is inadequate, followed by emicizumab prophylaxis to sustain bleed prevention and minimize steroid or IST exposure."

Glomerulonephritis • Hematological Disorders • Hemophilia • Hemophilia A • Infectious Disease • Nephrology • Pneumonia • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases

Case Report of a Pediatric Patient with Congenital Factor VII Deficiency (4%) using Human Recombinant Factor VIIa Eptacog-Beta as Secondary Prophylaxis (THSNA 2026) - "Currently, patients with congenital factor VII deficiency only have the option of using recombinant factor VIIa Eptacog alfa. This case report suggests that the use of Recombinant Factor VIIa Eptacog beta in pediatric patients with congenital factor VII deficiency as prophylaxis should be explored considering the lack of options for this population. 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."

Case report • Clinical • CNS Disorders • Epilepsy • Gastrointestinal Disorder • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Musculoskeletal Diseases • Osteoarthritis • Pediatrics • Rare Diseases

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Joseph Broderick

New P3 trial • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Recruiting | Sponsor: Joseph Broderick, MD | Trial completion date: Dec 2025 ➔ Jan 2028 | Trial primary completion date: Dec 2025 ➔ Jan 2028

Trial completion date • Trial primary completion date • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Recruiting | Sponsor: Joseph Broderick, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Joseph Broderick, MD | Trial completion date: Mar 2025 ➔ Aug 2025 | Trial primary completion date: Mar 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Joseph Broderick, MD | Trial completion date: Aug 2025 ➔ Mar 2025 | Trial primary completion date: Aug 2025 ➔ Mar 2025

Trial completion date • Trial primary completion date • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Joseph Broderick, MD | Trial completion date: Aug 2026 ➔ Aug 2025

Trial completion date • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Joseph Broderick, MD | Trial completion date: Jan 2026 ➔ Aug 2026 | Trial primary completion date: Jan 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - P3 | N=860 | Active, not recruiting | Sponsor: Joseph Broderick, MD | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Recurrence of FVIII Inhibitor during Surgery in a Patient with Severe Hemophilia A Receiving Emicizumab Prophylaxis. (PubMed, Acta Med Okayama) - "Activated partial thromboplastin time was prolonged on postoperative day 2, prompting an immediate switch to eptacog alfa. The patient recovered without bleeding. This case underscores the necessity of anti-idiotype monoclonal antibodies for accurate monitoring."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Successful hemodialysis initiation in acquired hemophilia a managed with susoctocog alfa and emicizumab. (PubMed, CEN Case Rep) - "Recombinant activated factor VII (rFVIIa, eptacog alfa) failed to control the bleeding; however, recombinant porcine sequence factor VIII (rpFVIII, susoctocog alfa) proved effective, enabling the safe placement of a long-term indwelling catheter for hemodialysis. To the best of our knowledge, there have been no prior reports of AHA cases requiring hemodialysis that were successfully treated with susoctocog alfa and emicizumab. This case highlights the potential role of these agents in optimizing hemostatic strategies for AHA patients undergoing hemodialysis."

Journal • Acute Kidney Injury • Glomerulonephritis • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Infectious Disease • Nephrology • Pneumonia • Rare Diseases • Renal Disease • Respiratory Diseases

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