Tehran University of Medical Sciences

Science Communicator Platform

Stay connected! Follow us on X network (Twitter):
Share By
Evaluation of Aryoseven Safety (Recombinant Activated Factor Vii) in Patients With Bleeding Disorders (An Observational Post-Marketing Surveillance Study)



Toogeh G1 ; Abolghasemi H2 ; Eshghi P2 ; Managhchi M1 ; Shaverdiniasari M1 ; Karimi K1 ; Roostaei S1 ; Emran N1 ; Abdollahi A1, 3
Authors

Source: Iranian Journal of Pathology Published:2016

Abstract

Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSevenTM as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. © 2016, Iran J Pathol. All rights reserved.
Related Docs
View other Related Docs
1. A Comparison Between Recombinant Activated Factor Vii (Aryoseven) and Novoseven in Patients With Congenital Factor Vii Deficiency, Clinical and Applied Thrombosis/Hemostasis (2015)
2. A Comparison of Efficacy Between Recombinant Activated Factor Vii (Aryoseven) and Novoseven in Patients With Hereditary Fviii Deficiency With Inhibitor, Clinical and Applied Thrombosis/Hemostasis (2016)
3. Cost-Effectiveness Analysis of Biogeneric Recombinant Activated Factor Vii (Aryoseven™) and Activated Prothrombin Complex Concentrates (Feiba™) to Treat Hemophilia a Patients With Inhibitors in Iran, Iranian Journal of Pharmaceutical Research (2016)
Experts (# of related papers)
View all Related Experts
Gholamreza Toogeh (6)
Shaban Alizadeh (3)
Other Related Docs
4. The First Discrete Choice Experiment on Usage of Bypassing Agents in Hemophilic Patients in Iran, Iranian Journal of Blood and Cancer (2016)
5. A Randomized, Two-Armed, Double-Blind, Single-Dose, Cross-Over, Bioequivalence Clinical Trial to Compare Pharmacokinetic Parameters and Safety of Recombinant Human Factor Viii With Fc Fusion Produced by Aryogen Pharmed Company Versus Elocta® (Reference Product) in Previously Treated Patients With Severe Haemophilia A, Annals of Hematology (2025)
6. Inhibitor Development in Patients With Congenital Factor Vii Deficiency, a Study on 50 Iranian Patients, Blood Coagulation and Fibrinolysis (2019)
7. Congenital Combined Deficiency of Coagulation Factors: A Study of Seven Patients, Blood Coagulation and Fibrinolysis (2015)
8. A Comprehensive Overview of Coagulation Factor V and Congenital Factor V Deficiency, Seminars in Thrombosis and Hemostasis (2019)
9. Guidelines for Laboratory Diagnosis of Factor Xiii Deficiency, Blood Coagulation and Fibrinolysis (2016)
10. Laboratory Diagnosis of Factor Xiii Deficiency, Routine Coagulation Tests With Quantitative and Qualitative Methods, Clinical Laboratory (2016)
11. Genetic Analysis of Non-Severe Hemophilia a Phenotype With a Discrepancy Between One-Stage and Chromogenic Factor Viii Activity Assays, Transfusion and Apheresis Science (2021)
12. Prevalence of Rare and Common Bleeding Disorders in Kurdistan Province of Iran, Journal of Cellular and Molecular Anesthesia (2019)
13. First Cases of Severe Congenital Factor Xiii Deficiency in Southwestern Afghanistan in the Vicinity of Southeast of Iran, Blood Coagulation and Fibrinolysis (2015)
14. Diagnosis, Clinical Manifestations and Management of Rare Bleeding Disorders in Iran, Hematology (2017)
15. Factor Xiii Deficiency in Iran: A Comprehensive Review of the Literature, Seminars in Thrombosis and Hemostasis (2015)
16. Correlation Between Phenotype and Coagulation Factor Activity Level in Rare Bleeding Disorders: A Systematic Review, Seminars in Thrombosis and Hemostasis (2025)
17. Parvovirus 4 in Individuals With Severe Hemophilia a and Matched Control Group, International Journal of Hematology-Oncology and Stem Cell Research (2021)
18. Anticoagulation Therapy in Iran, Annals of Blood (2019)
19. Expression and Synthesis of Recombinant Human Coagulation Factor Viii Using a Cell-Free Expression System, Journal of Babol University of Medical Sciences (2024)
20. Discrepancy Between the Results of One-Stage and Chromogenic Factor Viii:C Assays in Patients With Mild/Moderate Hemophilia A, Blood Coagulation and Fibrinolysis (2020)