- |||||||||| Sevenfact (eptacog beta activated) / LFB SA, HEMA Biologics
Journal, Real-world evidence, Real-world effectiveness, Real-world: Real-world effectiveness of eptacog beta in patients with haemophilia and inhibitors: A multi-institutional case series. (Pubmed Central) - Dec 20, 2024
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.
- |||||||||| The Influence of Coagulation Factor Biosimilars in Shortening the Activated Partial Thromboplastin Time in Patients with Hemophilia a () - Dec 7, 2024 - Abstract #ASH2024ASH_7560;
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.
- |||||||||| Review, Journal: Acquired haemophilia: Update in 2024 (Pubmed Central) - Nov 13, 2024
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.
- |||||||||| Humate-P (human plasma derived von Willebrand factor/FVIII complex) / CSL Behring, NovoSeven (eptacog alfa) / Novo Nordisk
Labor Epidural in Patient with Von Willebrand Disease and Factor VII Deficiency (Exhibit Hall) - Aug 6, 2024 - Abstract #ASA2024ASA_4181;
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.
- |||||||||| Comirnaty (tozinameran) / Pfizer, BioNTech, NovoSeven (eptacog alfa) / Novo Nordisk
Review, Journal: Severe acquired hemophilia A associated with COVID-19 vaccination: A case report and literature review. (Pubmed Central) - Aug 2, 2024
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.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
Review, Journal: Current status and future prospects of activated recombinant coagulation factor VIIa, NovoSeven (Pubmed Central) - Jul 28, 2024
Emerging non-factor therapies such as emicizumab have changed the treatment landscape of haemophilia A, including preventing bleeding in patients with CHwI. However, rFVIIa will continue to play a significant role in the treatment of such patients, particularly during breakthrough bleeding or surgical procedures.
- |||||||||| SS109 / Gensciences
Trial completion: SS109 and NovoSeven (clinicaltrials.gov) - Jul 19, 2024
P1/2, N=24, Completed,
However, rFVIIa will continue to play a significant role in the treatment of such patients, particularly during breakthrough bleeding or surgical procedures. Recruiting --> Completed
- |||||||||| SS109 / Gensciences
Trial primary completion date: SS109 and NovoSeven (clinicaltrials.gov) - Mar 2, 2024
P1/2, N=24, Recruiting,
Emicizumab concentrations are monitored by19/30 (63%) centers: 9 every 3-6 months, 4 annually, 1 Trial primary completion date: Jan 2024 --> May 2024
- |||||||||| Acquired Hemophilia A: A Rare Cause of Uncontrolled Hemorrhage in the Intensive Care Unit (San Diego Convention Center, Room 31A-C (Upper Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_7261;
Although rare, a high index of suspicion for AHA should remain for actively bleeding patients with a prolonged PTT, especially in elderly patients without family history of bleeding diathesis. Early recognition of AHA allows for consultation with a hematologist and prompt initiation of treatment to restore hemostasis and prevent the morbid consequences of this condition.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk, Rituxan (rituximab) / Roche
Plastic Surgery Gone Wrong: Catastrophic Post-operative Hemorrhagic Shock Due to Newly Acquired Factor VIII Inhibitor (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_3570;
She also received factor VII product (NovoSeven) repletion to bypass the inhibited coagulation pathway to attempt to synthesize adequate coagulation factors...Her hospital course was further complicated by the development of vancomycin-resistant enterococcus (VRE) bacteremia and Acinetobacter pneumonia...In our case, the factor inhibitor level responded only minimally despite all immune therapies. Early detection of this phenomenon in instances of unexplained hemorrhagic shock and ideally prior to surgery is necessary to rapidly suppress inhibitor levels before the development of catastrophic sequelae, as seen in our patient.
- |||||||||| Sevenfact (eptacog beta activated) / LFB SA, HEMA Biologics
Review, Journal: Eptacog beta for the management of patients with haemophilia A and B with inhibitors: A European perspective. (Pubmed Central) - Feb 6, 2024
In this review, we summarise current data regarding the mode of action, clinical efficacy and safety of eptacog beta for the management of haemophilia A and B in patients with inhibitors from a European perspective. In addition to providing a valuable summary of the analyses of the clinical data for eptacog beta conducted for the EMA, our review summarises the potential differentiators for eptacog beta compared with other current bypassing agents.
- |||||||||| SS109 / Gensciences
Enrollment open: SS109 and NovoSeven (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=24, Recruiting,
In addition to providing a valuable summary of the analyses of the clinical data for eptacog beta conducted for the EMA, our review summarises the potential differentiators for eptacog beta compared with other current bypassing agents. Not yet recruiting --> Recruiting
- |||||||||| SS109 / Gensciences
New P1/2 trial: SS109 and NovoSeven (clinicaltrials.gov) - Aug 25, 2023
P1/2, N=24, Not yet recruiting,
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, NovoSeven (eptacog alfa) / Novo Nordisk
Journal: Hematological treatment and prophylaxis in patients with and without inhibitors. (Pubmed Central) - Jun 4, 2023
Dose and frequency should be adjusted depending on the bleeding severity and type of factor concentrates (standard versus extended half-life products). Patients on emicizumab require bypassing agents (Novoseven is the agent of choice) in case of inhibitors and factor replacement in noninhibitor patients.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
Postpartum Renal Cortical Necrosis: Experience of a Center () - Mar 28, 2023 - Abstract #ISNWCN2023ISN_WCN_1316;
All patients received tranexamic acid...At 6 months of the postpartum 3 patients were in CKD stage 3b, and stage 5 not on dialysis. Conclusions RCN is a pathological diagnosis of a clinical entity characterized by the sudden onset of macroscopic hematuria, oliguria and anuria.The most commonly affected population is pregnant women with third trimester hemorrhage.The diagnosis is retained by renal biopsy puncture or by imaging
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Intrapulmonary Administration of Recombinant Activated Factor VII in a Patient With Diffuse Alveolar Hemorrhage and Microscopic Polyangiitis (Walter E. Washington Convention Center, Room 209 A-C (Level 2)) - Mar 25, 2023 - Abstract #ATS2023ATS_3223;
Treatment often involves high-dose glucocorticoids and other immunosuppressive agents such as cyclophosphamide and plasma exchange...The patient was treated with intravenous methylprednisolone and rituximab for the suspected diagnosis of MPA...4mg/46mL NaCl 0.9% (50cc total) reconstituted rFVIIa (NovoSeven RT) was bronchoscopically instilled into the left mainstem bronchus, the bronchus intermedius, and the right upper lobe bronchus...To our knowledge, among the vasculitides, its use in microscopic polyangiitis (MPA) has only been described systemically. Here we describe a patient
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
USING POINT OF CARE FOR CARDIAC SURGERY: FEASIBLE IN CONGENITAL AFIBRINOGENEMIA? () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_485;
ACT was adapted to the monitoring of heparin in this context. Although POC tests are precious tools in time sensitive situations, we would advise caution in the interpretation of global assays like viscoeslastic tests in patients with afibrinogenemia.
- |||||||||| concizumab (NN7415) / Novo Nordisk, NovoSeven (eptacog alfa) / Novo Nordisk
TFPI INHIBITION MIGHT BE USEFUL FOR THE TREATMENT OF UNDIAGNOSED BLEEDING DISORDERS () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_472;
Although POC tests are precious tools in time sensitive situations, we would advise caution in the interpretation of global assays like viscoeslastic tests in patients with afibrinogenemia. TFPI activity and antigen plasma level were measured in citrated plasma with ACTICHROME
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
HEMOPHILIA A, 3RD DEGREE WITH INHIBITOR DEVELOPMENT () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_276;
He is regulary monitored in the hematology infirmary, and he doesn't have substitution therapy. This case shows the importance of seeking for the main cause and providing a suitable treatment.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
Trial completion date, Trial primary completion date: FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) - Jan 26, 2023
P3, N=860, Recruiting,
Sponsored By Novo Nordisk Trial completion date: Dec 2025 --> Jan 2028 | Trial primary completion date: Dec 2025 --> Jan 2028
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk, AryoSeven (eptacog alfa biosimilar) / AryoGen Pharmed
A Generic Version of rFVIIa Is Bioequivalent to the Branded Version of rFVIIa (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3900;
These studies demonstrate that the two versions of FVIIa are comparable. Furthermore, these results warrant additional validation in animal models and clinical trials.
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche
Hemorrhagic and Thrombotic Adverse Events Associated with Emicizumab and Extended Half-Life FVIII Replacement Drugs in Patients with Hemophilia a: Data from the Eudravigilance Database (ENMCC - 288-290) - Nov 4, 2022 - Abstract #ASH2022ASH_1585;
Methods Total ADR reported during treatment with emicizumab or with EHL FVIII products (rurioctocog alfa pegol, efmoroctocog alfaturoctocog alfa pegol and danoctocog alfa pegol) retrieved from January 1st to December 31st, 2021 from EudraVigilance database were collected...Thrombotic ADR were 24 for emicizumab (i.e. 1 disseminated intravascular coagulation, 1 microangiopathy, 8 venous and 14 arterial thrombosis) and 9 for EHL FVIII products (i.e. 1 disseminated intravascular coagulation for danoctocog alfa pegol, 3 venous and 4 arterial thrombosis for efmoroctocog alfa and 1 arterial thrombosis for turoctocog alfa pegol).On the whole, about 25% of thrombotic ADR were reported in concomitance with eptacog alfa (activated)...However, this signal requires further validation by mean of cohort studies to estimate the magnitude of the adverse effect minimizing possible. Moreover, the treatment benefit-risk balance should be personalized according to the different hemostatic power of replacement and non-replacement drugs alongside with the individual bleeding and thrombotic risk factors.
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, NovoSeven (eptacog alfa) / Novo Nordisk, Feiba (human plasma derived anti-inhibitor coagulant complex) / Takeda
Acquired Hemophilia A (AHA) – Trends in Frequency and Treatment Patterns in Germany (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2347;
The number of cases per year has remained >400 since 2015. The use of emicizumab increased to about 10% of cases, whereas other treatments have changed only slightly since 2019.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
ACQUIRED HEMOPHILIA-POTENTIALLY FATAL IF NOT TREATED PROMPTLY () - May 13, 2022 - Abstract #EHA2022EHA_1080;
Immunosuppressive treatment was started with Cyclophosphamide 100mg and Prednisone 100mg daily...Conclusion This case report illustrates a case with acquired hemophilia A with delayed diagnosis and development of a life-threatening condition where the treatment was prolonged and the outcome uncertain. Whenever we have a patient with unexpected massive bleeding, without history of a bleeding disorder and prolonged APTT, we should consider acquired hemophilia and start treatment promptly.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
Overview of Hemostatic Effects of Exogenous Fibrin Monomer with Systemic Use in the Experiment (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2141;
The systemic administration of FM did not affect the analyzed parameters of the hemostasis system, in contrast to the prothrombogenic effects of known drugs with systemic hemostatic effects. The selective formation of fibrin in the area of injury was demonstrated when using exogenous FM.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk, Kineret (anakinra) / SOBI
Bleeding Story of An Adolescent: Factor VII Deficiency And Repeat Iliopsoas Bleeding (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1013;
He had strained his leg and had pain while playing basketball 5 days before.He was examined for prolonged bleeding and recurrent nosebleeds after circumcision, and was diagnosed with factor VII deficiency (F VII level was between 27-53%). He was also under follow-up from rheumatology due to the diagnosis of FMF and was using colchicine and anakinra.In the abdominal tomography, a 17 mm thick hematoma was observed in the left iliac fossa, near the ileopsoas muscle.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
A Case of Factor VII Deficiency Presented With Repeated Rectal Bleeding (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_912;
In the patient's history, it was learned that she was taking rFVIIa (Novoseven) twice a week with Factor VII deficiency. The patient had rectal bleeding accompanying abdominal pain at the age of 7 years.
- |||||||||| NovoSeven (eptacog alfa) / Novo Nordisk
Delayed Diagnosis of Acquired Hemophilia A Results in Worse Clinical Outcome (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_335;
Immunosuppressive treatment was started with Cyclophosphamide 100mg and Prednison 100mg daily. On the 8-th day of hospitalization NovoSeven was stopped as factor VIII level increased to 6.2% and the inhibitors dropped to 1.1BU.
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