NovoSeven (eptacog alfa) / Novo Nordisk - LARVOL DELTA

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

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

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

A novel assay for the quantification of extrinsic tenase complexes in clinical samples (ISTH 2025) - "Methods We generated a standard curve using rTF and recombinant activated factor VII (rFVIIa, eptacog alfa)...Intra-assay variability was <9% and the inter-assay variability was <7%. Table or Figure Upload"

Clinical • Breast Cancer • Oncology • Respiratory Diseases • Solid Tumor

Glanzmann's thrombasthenia in a twin pregnancy: A case report. (PubMed, Case Rep Womens Health) - "This case report details the contemporary, multidisciplinary management of a 35-year-old primigravid woman with a dichorionic, diamniotic twin pregnancy and GT which included an elective caesarean section under general anaesthesia performed at 36 + 5 weeks of gestation, with recombinant factor VIIa (NovoSeven) and tranexamic acid (TXA) treatment preoperatively and pre-emptive uterotonic administration intraoperatively to minimise haemorrhage. Postpartum management included a seven-week course of TXA. This case highlights the importance of a proactive, multidisciplinary care plan to optimize pregnancy outcomes in women with GT, with a focus on minimizing the risk of severe haemorrhage."

Journal • Anesthesia • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Comparative Efficacy of Recombinant FVIII and Recombinant FVII Biosimilars in Severe Hemophilia A. (PubMed, Clin Appl Thromb Hemost) - "The only possible treatment for this bleeding condition is factor concentrate.AimThe aim of this study is to compare the effect of recombinant factor VIII (rFVIII) and recombinant factor VII (rFVII) on prothrombin time (PT), activated partial thromboplastin time (aPTT), FVIII and FVII in severe HA.MethodologyA mixing study was conducted on 30 samples of severe HA patients to assess the correction of PT, aPTT, FVIII, and FVII values using biosimilars of rFVIII (NovoEight and Kogenate FS) and rFVII (NovoSeven and AryoSeven) using a fully automated coagulation analyser 'Ceveron alpha'.ResultsAll the four drugs demonstrated a significant alteration for both PT (P < .0001) and aPTT (P < .0001) values. Two different groups of biosimilars were found to have a high potential to alter the PT and aPTT values. The FVIII biosimilars are efficient in increasing the FVIII levels."

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

Inhibitor Eradication in Postpartum Acquired Haemophilia A: Real-Life Case Series and Literature Review. (PubMed, Haemophilia) - "Notwithstanding that postpartum AHA has been reported to have a high rate of spontaneous remission, nearly half of this series experienced inhibitor eradication more than 1 month after disease onset and using immunosuppressive treatment for more than 2 months, with additional drugs being used in more than 40% of them, thus showing difficulties in disease remission in this postpartum AHA subpopulation."

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

Recombinant factor VIIa: new insights into the mechanism of action through product innovation. (PubMed, Res Pract Thromb Haemost) - "Eptacog alfa and eptacog beta share the same amino acid sequence but differ in posttranslational modifications. Further research is required to assess the clinical relevance of these differences. A better understanding of the mechanisms by which rFVIIa promotes hemostasis in patients will provide insights when evaluating clinical outcomes of safety and efficacy for innovative bypassing therapies."

Journal • Review • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • PROCR

Novo Nordisk's sales increased by 25% in Danish kroner and by 26% at constant exchange rates to DKK 290.4 billion in 2024 (GlobeNewswire) - "Sales of rare blood disorder products increased by 7% in both Danish kroner and at CER, mainly driven by increased haemophilia B sales and NovoSeven...EMEA...Sales of rare blood disorder products decreased by 2% in both Danish kroner and CER, driven by lower NovoSeven and haemophilia A sales, partially countered by increased haemophilia B sales."

Sales • Hemophilia A • Hemophilia B

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

Labor Epidural in Patient with Von Willebrand Disease and Factor VII Deficiency (ASA 2024) - "Postpartum, von Willebrand factor activity (targeting >50% with Humate-P) and Factor VII activity (targeting >20% with NovoSeven) were trended, and she received peripartum tranexamic acid. This case highlights obstetric, anesthetic, and ethical challenges that inherited bleeding disorders carry."

Clinical • Anesthesia • CNS Disorders • Hematological Disorders • Hemophilia • Obstetrics • Pain • Postpartum Hemorrhage

Real-world effectiveness of eptacog beta in patients with haemophilia and inhibitors: A multi-institutional case series. (PubMed, Haemophilia) - "In this case series, eptacog beta was safe, effective, and economical as first-line therapy, treatment of refractory BEs, management of perioperative bleeding, or prophylaxis in haemophilia patients with inhibitors."

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

Acquired haemophilia: Update in 2024 (PubMed, Rev Med Interne) - "Eradication of inhibitor should be established as soon as the diagnosis is confirmed with steroid alone often associated with cytotoxic agents or rituximab, depending on FVIII activity and inhibitor titer. The purpose of this review is to summarize the epidemiology, etiopathogenesis, diagnosis, treatment of AHA and discuss current recommendations."

Journal • Review • Hematological Disorders • Hemophilia • Immunology • Oncology • Rare Diseases

Severe acquired hemophilia A associated with COVID-19 vaccination: A case report and literature review. (PubMed, Medicine (Baltimore)) - "This rare case underscores the importance of monitoring for AHA following COVID-19 vaccination. Although the benefits outweigh the risks of vaccination, AHA should be considered in the differential diagnosis of unusual bleeding following the vaccinations. Early diagnosis and management before severe bleeding are critical for successfully controlling life-threatening bleeding."

Journal • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Critical care • Dermatology • Diabetes • Dyslipidemia • Hematological Disorders • Hemophilia • Hypertension • Immunology • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Rare Diseases • Septic Shock

SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Jiangsu Gensciences lnc. | Recruiting ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

THE ROLE OF IMMUNOSUPPRESSIVE THERAPY FOR INHIBITORS ERADICATION IN POSTPARTUM ACQUIRED HEMOPHILIA A. ARE STEROIDS ALONE ENOUGH? A REAL-LIFE RETROSPECTIVE EXPERIENCE. (EHA 2024) - "All patients required anti-hemorrhagic therapy with a medium duration of 8 days (range 1-28days): 60% (9/15) received eptacog alfa, one was treated with activated prothrombin complex concentrate,while both drugs were administered in combination in three of them (20%). The immunosuppressive treatmentwas steroids alone in nine patients, 27% (4/15) received azathioprine or cyclophosphamide in combination withprednisone, while in two patients rituximab immunotherapy was used following immunosuppressivecombination therapy... Major bleeding was present in two-thirds of postpartum AHA patients and was successfully treated withbypassing agents. Postpartum AHA has been reported to have a high rate of spontaneous remission. However,nearly half of the population had inhibitor eradication more than one month after disease onset, usingimmunosuppressive treatment for more than 2 months, and additional drugs were used in 40% of them,evidencing difficulties in treatment remission in..."

Retrospective data • Gastroenterology • Gastrointestinal Disorder • Gynecology • Hematological Disorders • Hemophilia • Immunology • Rare Diseases

MANAGEMENT OF ACQUIRED SEVERE HEMOPHILIA ACCORDING TO THE LATEST INTERNATIONAL GUIDELINES AND THE INFECTIOUS AND INFLAMMATORY COMPLICATIONS DERIVED. (EHA 2024) - "It isstarted at this time with the diagnosis of Severe Acquired Hemophilia A, eptacog alfa 5 mg/8 hours,methylprednisolone 100 mg/24 hours and, on October 3, 2023, cyclophosphamide 2 mg/Kg is started. Early diagnosis of acquired hemophilia is of vital importance to provide timely treatment in order to avoidbleeding with serious complications. The availability of the new guidelines that support the first-line use of corticosteroids and immunosuppressantstogether with Rituximab when it is a severe case, represents an important advance in terms of the resolution ofthe condition, but may condition the appearance of a greater number of infectious complications. Infectious complications are a cause of important morbidity and mortality in patients with acquired HemophiliaA under immunosuppressive treatment."

Cytomegalovirus Infection • Dermatology • Gastrointestinal Disorder • Hematological Disorders • Hemophilia • Immunology • Infectious Disease • Mood Disorders • Musculoskeletal Pain • Pain • Psoriasis • Rare Diseases • Rheumatology

A survey of clinical practice of laboratory monitoring and management of bleeding in children on emicizumab prophylaxis in the PedNet centers (ISTH 2024) - "In children with previous inhibitors on emicizumab and major bleed 12 treat with Novoseven, 11 with FVIII concentrate and 6 based on clinical situation. 30/32 centers responded, 25 had used emicizumab > 4 , 2 centers 3-4 ,3 centers 2-3 years. Emicizumab concentrations are monitored by19/30 (63%) centers: 9 every 3-6 months, 4 annually, 1 “sometimes”, 3 more in the beginning, 8 -if clinical concerns. FVIII inhibitor testing is available in all centers."

Clinical • Hematological Disorders • Hemophilia • Rare Diseases

An Open-label,Dose-Escalation,Multicenter Phase I Study to Evaluate the Safety,Immunogenicity,and Pharmacokinetics/pharmacodynamics（PK/PD）of Single Dose SS109 in Hemophilia A/B patients with Inhibitor (ISTH 2024) - "Nonclinical studies showed that the hemostasis of SS109 is better than that of NovoSeven® in same dose, and half-life is 2.5 times longer than that of NovoSeven® in cynomolgus monkeys... Single dose of SS109 at all 5 doses was well-tolerated. Two adverse events occurred in 2 patients (7.4%) were possibly related to SS109. No hypersensitivity or allergic reactions occurred."

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

Evaluation of Coagulation Factor VII Biosimilars (AryoSeven Vs NovoSeven) in Modulating Prothrombin Time, activated Partial Thromboplastin Time, and levels of Factors VII and VIII in Hemophilia A (ISTH 2024) - "In a comparison of both of the investigational drugs to the original values of PT, aPTT, FVII, and FVIII, among-group comparison with post-hoc pairwise comparisons showed a high statistically significant difference in values of all four parameters, compared to pre-treatment values (Table 1). No difference was observed between the values of all four investigated parameters after adding AryoSeven and NovoSeven. A negative correlation was observed between aPTT and FVIII values after adding AryoSeven (r=-0.647, p< 0.001)."

Hematological Disorders • Hemophilia • Rare Diseases