ArticleJournal of blood medicine2019
Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC).
Article in Journal of blood medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Efficacy and safety of recombinant activated factor VII in Glanzmann thrombasthenia: A systematic literature review.Haemophilia : the official journal of the World Federation of Hemophilia · 2025Pooled it
- Safety and Use of Eptacog Beta 225 µg/kg in Patients With Haemophilia A or B With Inhibitors.Haemophilia : the official journal of the World Federation of Hemophilia · 2025Trial
- Cost-effectiveness analysis of emicizumab use in hospitalized older individuals with acquired hemophilia A.Blood vessels, thrombosis & hemostasis · 2026Article
- Guideline on the emergency management of critical bleeding in patients with immune thrombocytopenia.Blood advances · 2026Article
- Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study.Blood vessels, thrombosis & hemostasis · 2026Article
- Venous Thromboembolism in Inherited Platelet Disorders: A Clinical Challenge.Diagnostics (Basel, Switzerland) · 2025Review
- Activated prothrombin complex concentrate in patients receiving emicizumab prophylaxis: from evidence to clinical practice.Research and practice in thrombosis and haemostasis · 2025Review
- Recombinant factor VIIa: new insights into the mechanism of action through product innovation.Research and practice in thrombosis and haemostasis · 2025Review
- Current status and future prospects of activated recombinant coagulation factor VIIa, NovoSeven®, in the treatment of haemophilia and rare bleeding disorders.Annals of hematology · 2024Review
- Asymptomatic COVID-19-Associated Acquired Hemophilia A and Disseminated Intravascular Coagulation From a Bypassing Agent.Journal of medical cases · 2024Article
- Acquired Hemophilia A and ST-Elevation Myocardial Infarction (STEMI): A Rare Presentation and Management Dilemma.Cureus · 2023Article
- How to manage bleeding disorders in aging patients needing surgery.Hematology. American Society of Hematology. Education Program · 2021Article
- Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human fviia) and emicizumab in congenital haemophilia A plasma.Haemophilia : the official journal of the World Federation of Hemophilia · 2021Article
- FVIIa (Factor VIIa) Induces Biased Cytoprotective Signaling in Mice Through the Cleavage of PAR (Protease-Activated Receptor)-1 at Canonical Arg41 (Arginine41) Site.Arteriosclerosis, thrombosis, and vascular biology · 2020Article
- Disease Burden in Patients with Glanzmann's Thrombasthenia: Perspectives from the Glanzmann's Thrombasthenia Patient/Caregiver Questionnaire.Journal of blood medicine · 2020Article
- Psychosocial Impact and Disease Management in Patients with Congenital Factor VII Deficiency.Journal of blood medicine · 2020Article
Corrections and comments
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Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRecombinant activated factor VII (rFVIIa; NovoSeven PATIENTS AND
methodsA retrospective safety assessment of both clinical trials and registries used to support licensure and postmarketing surveillance was performed. The rate of thrombosis was calculated in the 4 indicated disorders and an assessment of TE risk factors was conducted through a review of all narratives within those indications in the safety database.
resultsIn clinical trials and registries used to support licensure and in postmarketing surveillance, the overall rate of thrombosis was 0.17% of 12,288 bleeding and surgical episodes. The specific risk by indication was 0.11% for CHwI, 0.82% for FVII deficiency, 0.19% for GT, and 1.77% for AH. The most common associated risk factor-"elderly" (29%), defined in the PI as age ≥65 years-was particularly prevalent in patients with AH. TE was also frequently reported with concomitant cardiac or vascular disease (18%) and use of activated prothrombin complex concentrates (18%).
conclusionData show that the rate of TEs within the 4 licensed indications is low, as was originally described in the US PI from 1999 to 2009. It has remained stable over time during postapproval surveillance in multiple US and global registries with active surveillance for safety information across the 4 approved indications.
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