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recombinant factor VII

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https://www.readbyqxmd.com/read/28604077/-activated-factor-vii-31-years-experience-on-clinical-grounds
#1
Miklós Udvardy
The author provides an overview of the use of recombinant activated FVII (rFVIIa, Novoseven), which is used over 30 years, based upon international publications and also on some modest own experience. Standard, approved indications (inhibitory cases, Glanzmann thrombasthenia, prophylaxis experience) are in the focus of this paper, emphasizing the specially rapid and efficacious way of Novoseven therapy, drawing attention to excellent safety issues regarding very low immunogenicity along with low number of thrombogenic complications...
June 2017: Orvosi Hetilap
https://www.readbyqxmd.com/read/28603894/a-performance-evaluation-of-a-novel-human-recombinant-tissue-factor-prothrombin-time-reagent-revohem-%C3%A2-pt
#2
C Gardiner, K Kohama, I Patel, P Lane, S Dwyer, S J Machin, I J Mackie
INTRODUCTION: A new prothrombin time reagent (Revohem™ PT) based on recombinant human tissue factor produced by the silkworm-baculovirus expression system was tested. The aim of this study was to compare the performance of the new PT reagent with two widely used routine PT reagents. METHODS: All testing was performed on a Sysmex CS-5100 coagulometer. Revohem(™) PT was tested for imprecision and stability using normal and abnormal lyophilized commercial control plasmas...
June 12, 2017: International Journal of Laboratory Hematology
https://www.readbyqxmd.com/read/28594467/biochemical-characterization-of-lr769-a-new-recombinant-factor-viia-bypassing-agent-produced-in-the-milk-of-transgenic-rabbits
#3
G Chevreux, N Tilly, Y Leblanc, C Ramon, V Faid, M Martin, F Dhainaut, N Bihoreau
BACKGROUND: The bypassing agent factor VII (FVIIa) is a first-line therapy for the treatment of acute bleeding episodes in patients with haemophilia and high-titre inhibitors. FVIIa is a highly post-translationally modified protein that requires eukaryotic expression systems to produce a fully active molecule. A recombinant FVIIa was produced in the milk of transgenic rabbits to increase expression and provide an efficient, safe and affordable product after purification to homogeneity (LR769)...
June 8, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28589615/safety-and-efficacy-of-recombinant-activated-coagulation-factor-vii-in-congenital-hemophilia-with-inhibitors-in-the-home-treatment-setting-a-review-of-clinical-studies-and-registries
#4
REVIEW
Guy Young, Miguel A Escobar, Steven W Pipe, David L Cooper
Self-administration of factor and bypassing agents by persons with hemophilia in the home setting is recommended to facilitate earlier intervention after bleeding episodes. The objective of this review was to summarize recombinant activated coagulation factor VII (rFVIIa) safety and efficacy data from clinical trials and patient registries documenting use in the home treatment setting in people with congenital hemophilia with inhibitors (CHwI). A total of 16 studies and registries were identified for inclusion; 14 evaluated on-demand treatment of acute bleeding episodes (865 patients, 9024 bleeding episodes) and 2 evaluated use for secondary prophylaxis (108 patients, 42,861 prophylaxis days)...
June 7, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28526142/anticoagulant-reversal-and-anesthetic-considerations
#5
REVIEW
Joseph Meltzer, Joseph R Guenzer
Bleeding complications are a common concern with the use of anticoagulant agents. In many situations, reversing of neutralizing their effects may be warranted. Prothrombin complex concentrate replaces coagulation factors lowered by warfarin, as does fresh frozen plasma, but in a more concentrated form. Protamine negates the effect of heparin and combines chemically with heparin molecules to form an inactive salt. It also partially reverses the effects of low-molecular-weight heparin. Recombinant activated factor VII is a nonspecific procoagulant that activates the extrinsic clotting pathway, resulting in thrombin generation, but does not directly neutralize the activity of any of the new oral anticoagulants...
June 2017: Anesthesiology Clinics
https://www.readbyqxmd.com/read/28512017/a-case-of-autoimmune-severe-acquired-von-willebrand-syndrome-type-3-like
#6
Chakri Gavva, Prapti Patel, Yu-Min Shen, Eugene Frenkel, Ravi Sarode
Von Willebrand disease (VWD) is the most common congenital bleeding disorder and is due to quantitative or qualitative defects of von Willebrand factor (VWF). Acquired defects of VWF, termed acquired von Willebrand syndrome (AVWS), are due to a host of different mechanisms. Autoantibody-mediated AVWS may be associated with lymphoproliferative or immunological disorders, such as systemic lupus erythematosus (SLE). A large majority of AVWS cases are type 1 or type 2A-like and patients tend to have a mild to moderate bleeding tendency...
April 27, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/28496951/can-aptameric-ligands-specific-to-plasma-coagulation-factor-vii-bind-the-recombinant-form-with-high-affinity-affinity-measurement-by-fluorescence-method
#7
Maryam Tabarzad, Marzieh Jafari, Nastaran Nafissi-Varcheh
BACKGROUND: Among diverse protein purification systems, affinity chromatography is the most attractive one in the purification process of coagulation factors. Coagulation factor VII is a plasma serine protease that has a significant role in natural human hemostasis and its recombinant form such as AryoSeven(™), has been applied in clinical treatment of bleeding disorders. Immunoaffinity chromatography is the purification method of choice that is currently applied in the development of coagulation factor VIIa products...
April 2017: Avicenna Journal of Medical Biotechnology
https://www.readbyqxmd.com/read/28496540/recombinant-factor-viia-use-for-endoscopic-retrograde-cholangiopancreatography-with-sphincterotomy-in-a-patient-with-choledocholithiasis-and-unusual-coagulopathy
#8
Molham Abdulsamad, Pavithra Reddy, Suvarna Guvvala, Anil Dev
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that combines the use of endoscopy and fluoroscopy to diagnose and treat pancreaticobiliary disorders. The risks of ERCP include pancreatitis, infection, bleeding and perforation. Bleeding during ERCP typically develops after sphincterotomy, hence patients should be screened and tested for coagulopathy before undergoing ERCP. Coagulopathy is a major risk factor for ERCP-related bleeding. Inherited factor VII (FVII) deficiency is a rare autosomal recessive hemorrhagic disorder that can lead to significant coagulopathy and severe bleeding if not appropriately recognized and treated preoperatively...
April 2017: Gastroenterology Research
https://www.readbyqxmd.com/read/28487393/potent-thrombolytic-effect-of-n-acetylcysteine-on-arterial-thrombi
#9
Sara Martinez de Lizarrondo, Clément Gakuba, Bradley A Herbig, Yohann Repessé, Carine Ali, Cécile V Denis, Peter Lenting, Emmanuel Touzé, Scott L Diamond, Denis Vivien, Maxime Gauberti
Background -Platelet crosslinking during arterial thrombosis involves von Willebrand Factor (VWF) multimers. Therefore, proteolysis of VWF appears promising to disaggregate platelet-rich thrombi and restore vessel patency in acute thrombotic disorders such as ischemic stroke, acute coronary syndrome or acute limb ischemia. N-Acetylcysteine (NAC, a clinically approved mucolytic drug) can reduce intrachain disulfide bonds in large polymeric proteins. In the present study, we postulated that NAC might cleave the VWF multimers inside occlusive thrombi, thereby leading to their dissolution and arterial recanalization...
May 9, 2017: Circulation
https://www.readbyqxmd.com/read/28452972/pulmonary-embolism-in-a-patient-with-mild-factor-vii-deficiency-after-administration-of-recombinant-activated-factor-vii-during-a-urological-procedure
#10
Tomasz Skowerski, Katarzyna Bańska-Kisiel, Patryk Grzywocz, Mariusz Skowerski, Zbigniew Gąsior
No abstract text is available yet for this article.
April 28, 2017: Polish Archives of Internal Medicine
https://www.readbyqxmd.com/read/28440004/safety-and-effectiveness-of-room-temperature-stable-recombinant-factor-viia-in-patients-with-haemophilia-a-or-b-and-inhibitors-results-of-a-multinational-prospective-observational-study
#11
K Kavakli, F Demartis, M Karimi, P Eshghi, D Neme, H Chambost, L Sommer, M Zak, G Benson
INTRODUCTION: A room temperature stable formulation of recombinant activated factor VII (NovoSeven(®) ), allowing convenient storage and therefore improved treatment access, has been developed. Bioequivalence to the previous NovoSeven(®) was demonstrated in healthy humans, leading to European approval (2008). Although no confirmed cases of neutralising antibodies to rFVIIa in patients with haemophilia A or B have been observed with the original formulation, changes in formulation or storage condition may alter immunogenicity...
April 24, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28435309/recognition-and-management-of-platelet-refractory-bleeding-in-patients-with-glanzmann-s-thrombasthenia-and-other-severe-platelet-function-disorders
#12
Meera Chitlur, Madhvi Rajpurkar, Michael Recht, Michael D Tarantino, Donald L Yee, David L Cooper, Sriya Gunawardena
Patients with rare qualitative platelet disorders or platelet function disorders (PFDs) may present to the hospital physician with severe bleeding episodes or excessive surgical bleeding. Although standard treatment consists of platelet transfusions, repeated transfusions may result in the development of antiplatelet antibodies (APA) or clinical refractoriness, rendering further platelet therapy ineffective. In such settings, an approved treatment option for patients with Glanzmann's thrombasthenia (GT), one of the well-known rare PFDs, is recombinant activated coagulation factor VII (rFVIIa)...
2017: International Journal of General Medicine
https://www.readbyqxmd.com/read/28420167/treatment-and-prevention-of-bleeds-in-haemophilia-patients-with-inhibitors-to-factor-viii-ix
#13
REVIEW
Angiola Rocino, Massimo Franchini, Antonio Coppola
The development of alloantibodies neutralising therapeutically administered factor (F) VIII/IX (inhibitors) is currently the most severe complication of the treatment of haemophilia. When persistent and at a high titre, inhibitors preclude the standard replacement treatment with FVIII/FIX concentrates, making patients' management challenging. Indeed, the efficacy of bypassing agents, i.e., activated prothrombin complex concentrates (aPCC) and recombinant activated factor VII (rFVIIa), needed to overcome the haemostatic interference of the inhibitor, is not comparable to that of factor concentrates...
April 17, 2017: Journal of Clinical Medicine
https://www.readbyqxmd.com/read/28393462/current-use-of-factor-concentrates-in-pediatric-cardiac-anesthesia
#14
REVIEW
Nina A Guzzetta, Glyn D Williams
Excessive bleeding following pediatric cardiopulmonary bypass is associated with increased morbidity and mortality, both from the effects of hemorrhage and the therapies employed to achieve hemostasis. Neonates and infants are especially at risk because their coagulation systems are immature, surgeries are often complex, and cardiopulmonary bypass technologies are inappropriately matched to patient size and physiology. Consequently, these young children receive substantial amounts of adult-derived blood products to restore adequate hemostasis...
July 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28335637/reversing-the-anticoagulation-effects-of-dabigatran
#15
REVIEW
William E Dager, Linda Banares
The standard of care for oral anticoagulation therapy has primarily been warfarin, which is limited by its indirect mechanism-of-action, variable kinetics, tolerability, and routine monitoring concerns. The direct-acting oral anticoagulants (DOACs) have predictable pharmacokinetics and pharmacodynamics, and improved safety and efficacy compared to warfarin for the prevention of stroke in patients with nonvalvular atrial fibrillation and prevention or management of venous thromboembolism. Consequential bleeding is a concern with all anticoagulants...
April 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28265390/thrombosis-in-a-bleeding-disorder-case-of-thromboembolism-in-factor-vii-deficiency
#16
Sheryl K Ramdass, Kah Poh Loh, Leslie M Howard
Congenital factor VII deficiency (FVIID) is a rare disorder with a wide range of bleeding manifestations. The disorder does not protect patients against occurrence of thrombosis, and deep vein thrombosis can occur in the setting of surgery and recombinant factor VIIa replacement.
March 2017: Clinical Case Reports
https://www.readbyqxmd.com/read/28255432/response-to-treatment-and-adverse-events-associated-with-use-of-recombinant-activated-factor-vii-in-children-a-retrospective-cohort-study
#17
James D Cooper, Arthur K Ritchey
BACKGROUND: Recombinant activated factor VII (rFVIIa) is United States (US) Food and Drug Administration (FDA)-approved for patients with hemophilia with inhibitors or congenital factor VII deficiency. Initial reports of off-label use highlighted its efficacy, though newer reports have not repeated these findings. In both types of publication, though, secondary thromboses have been seen in adult patients. The data in children are less clear. METHODS: This study analyzed all rFVIIa use at a large children's hospital for characteristics and outcomes...
February 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28239301/the-reversal-effect-of-prothrombin-complex-concentrate-pcc-activated-pcc-and-recombinant-activated-factor-vii-against-anticoagulation-of-xa-inhibitor
#18
Nina Haagenrud Schultz, Hoa Thi Tuyet Tran, Stine Bjørnsen, Carola Elisabeth Henriksson, Per Morten Sandset, Pål Andre Holme
BACKGROUND: An increasing number of patients are treated with direct-acting oral anticoagulants (DOACs), but the optimal way to reverse the anticoagulant effect is not known. Specific antidotes are not available and prothrombin complex concentrate (PCC), activated PCC (aPCC) and recombinant factor VIIa (rFVIIa) are variously used as reversal agents in case of a major bleeding. We aimed to determine the most effective haemostatic agent and dose to reverse the effect of rivaroxaban in blood samples from patients taking rivaroxaban for therapeutic reasons...
2017: Thrombosis Journal
https://www.readbyqxmd.com/read/28225743/damage-control-resuscitation-in-patients-with-severe-traumatic-hemorrhage-a-practice-management-guideline-from-the-eastern-association-for-the-surgery-of-trauma
#19
Jeremy W Cannon, Mansoor A Khan, Ali S Raja, Mitchell J Cohen, John J Como, Bryan A Cotton, Joseph J Dubose, Erin E Fox, Kenji Inaba, Carlos J Rodriguez, John B Holcomb, Juan C Duchesne
BACKGROUND: The resuscitation of severely injured bleeding patients has evolved into a multi-modal strategy termed damage control resuscitation (DCR). This guideline evaluates several aspects of DCR including the role of massive transfusion (MT) protocols, the optimal target ratio of plasma (PLAS) and platelets (PLT) to red blood cells (RBC) during DCR, and the role of recombinant activated factor VII (rVIIa) and tranexamic acid (TXA). METHODS: Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, a subcommittee of the Practice Management Guidelines (PMG) Section of EAST conducted a systematic review using MEDLINE and EMBASE...
March 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28223242/fviia-prevents-the-progressive-hemorrhaging-of-a-brain-contusion-by-protecting-microvessels-via-formation-of-the-tf-fviia-fxa-complex
#20
Qiang Yuan, Dalong Zhang, Sirong Wu, Jian Yu, Lei Yu, Yirui Sun, Zhuoying Du, Zhiqi Li, Liangfu Zhou, Xing Wu, Jin Hu
Factor VII (FVII) plays a key role in the initiation of the coagulation cascade and, in clinical situations, recombinant human activated FVII (rFVIIa) effectively prevents progressive hemorrhaging after a brain contusion. However, it remains unclear whether decreases in FVII activity directly lead to progressive hemorrhaging and, moreover, the precise mechanisms underlying this process are not yet known. The present study demonstrated that decreased FVII activity directly led to progressive hemorrhaging of the cerebral contusions...
February 20, 2017: Neuroscience
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