References
- Mumford AD, Ackroyd S, Alikhan R, et al. Guideline for the diagnosis and management of the rare coagulation disorders: a United Kingdom haemophilia centre doctors’ organization guideline on behalf of the British committee for standards in haematology. Br J Haematol. 2014;167:304–326.
- Bolton-Maggs PH, Perry DJ, Chalmers EA, et al. The rare coagulation disorders–review with guidelines for management from the United Kingdom haemophilia centre doctors’ organisation. Haemophilia. 2004;10:593–628.
- Uprichard J, Perry DJ. Factor X deficiency. Blood Rev. 2002;16:97–110.
- Palla R, Peyvandi F, Shapiro AD. Rare bleeding disorders: diagnosis and treatment. Blood. 2015;125:2052–2061.
- Brown D, Kouides P. Diagnosis and treatment of inherited factor X deficiency. Haemophilia. 2008;14:1176–1182.
- Peyvandi F, Mannucci PM, Lak M, et al. Congenital factor X deficiency: spectrum of bleeding symptoms in 32 Iranian patients. Br J Haematol. 1998;102:626–628.
- Herrmann FH, Auerswald G, Ruiz-Saez A, et al. Factor X deficiency: clinical manifestation of 102 subjects from Europe and Latin America with mutations in the factor 10 gene. Haemophilia. 2006;12:479–489.
- Nance D, Josephson NC, Paulyson-Nunez K, et al. Factor X deficiency and pregnancy: preconception counselling and therapeutic options. Haemophilia. 2012;18:e277–e285.
- Menegatti M, Peyvandi F. Factor X deficiency. Semin Thromb Hemost. 2009;35:407–415.
- Keeling D, Tait C, Makris M. Guideline on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. A United Kingdom Haemophilia Center Doctors’ Organisation (UKHCDO) guideline approved by the British committee for standards in haematology. Haemophilia. 2008;14:671–684.
- Giangrande P, Seitz R, Behr-Gross ME, et al. Kreuth III: European consensus proposals for treatment of haemophilia with coagulation factor concentrates. Haemophilia. 2014;20:322–325.
- Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders (revised February 2016); cited 15 June 2016. Available from: https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendations-Concerning-Products-Licensed-for-the-Treatment-of-Hemophilia-and-Other-Bleeding-Disorders
- Bio Products Laboratory. Coagadex® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection. Prescribing Information; [cited 27 June 2016]. Available from: http://www.coagadex.com/download/Coagadex_PI_10-2015.pdf
- European Medicines Agency. Coagadex. Summary of product characteristics (SmPC); [cited 27 June 2016]. Available from: https://www.medicines.org.uk/emc/medicine/31626#PRODUCTINFO
- Austin SK, Brindley C, Kavakli K, et al. Pharmacokinetics of a high-purity plasma-derived factor X concentrate in subjects with moderate or severe hereditary factor X deficiency. Haemophilia. 2016;22:426–432.
- Austin SK, Kavakli K, Norton M, et al. Efficacy, safety and pharmacokinetics of a new high-purity factor X concentrate in subjects with hereditary factor X deficiency. Haemophilia. 2016;22:419–425.
- Escobar MA, Auerswald G, Austin S, et al. Experience of a new high-purity factor X concentrate in subjects with hereditary factor X deficiency undergoing surgery. Haemophilia. 2016;22:713–720.
- McMahon C, Smith J, Goonan C, et al. The role of primary prophylactic factor replacement therapy in children with severe factor X deficiency. Br J Haematol. 2002;119:789–791.
- Karimi M, Vafafar A, Haghpanah S, et al. Efficacy of prophylaxis and genotype-phenotype correlation in patients with severe Factor X deficiency in Iran. Haemophilia. 2012;18:211–215.
- Peyvandi F, Palla R, Menegatti M, et al. Coagulation factor activity and clinical bleeding severity in rare bleeding disorders: results from the European network of rare bleeding disorders. J Thromb Haemost. 2012;10:615–621.
- Franchini M, Lippi G. Prothrombin complex concentrates: an update. Blood Transfus. 2010;8:149–154.
- Kohler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res. 1999;95:S13–S17.
- Mannucci PM, Duga S, Peyvandi F. Recessively inherited coagulation disorders. Blood. 2004;104:1243–1252.
- Auerswald G. Prophylaxis in rare coagulation disorders – factor X deficiency. Thromb Res. 2006;118(Suppl 1):S29–S31.
- Escobar MA. Advances in the treatment of inherited coagulation disorders. Haemophilia. 2013;19:648–659.
- Windyga J, Solano Trujillo MH, Hafeman AE. BAX326 (RIXUBIS): a novel recombinant factor IX for the control and prevention of bleeding episodes in adults and children with hemophilia B. Ther Adv Hematol. 2014;5:168–180.
- Voelker R. A first in hemophilia B therapy. JAMA. 2016;315:1555.
- Mikaelsson M, Oswaldsson U, Jankowski MA. Measurement of factor VIII activity of B-domain deleted recombinant factor VIII. Semin Hematol. 2001;38:13–23.
- Food and Drug Administration. Summary basis for regulatory action – Coagadex; [cited 2016 June 27]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM472266.pdf
- European Medicines Agency. Committee for medicinal products for human use. Coagadex. Assessment report; [cited 2016 June 27]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003855/WC500204191.pdf
- Ostermann H, Haertel S, Knaub S, et al. Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers. Thromb Haemost. 2007;98:790–797.
- ClinicalTrials.gov. A study to investigate BPL’s factor X in the prophylaxis of bleeding in children <12 Years; [cited 2016 June 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT01721681
- National Health Service Health Research Authority. Data collection to investigate compassionate use with FACTOR X: a multicenter, retrospective data collection study on the use of BPL’s high purity factor X in the treatment of patients with hereditary factor X deficiency: Ten05; [cited 2016 June 30]. Available from: http://www.hra.nhs.uk/news/research-summaries/data-collection-to-investigate-compassionate-use-with-factor-x/
- US Food and Drug Administration. Biologics license application approval for coagulation factor X (human); [cited 2016 June 15]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM468124.pdf
- Mitchell M, Kavakli K, Norton M, et al. Genotype analysis of patients with hereditary factor X deficiency enrolled in 2 phase 3 studies of pdFX, a new high-purity factor X concentrate [abstract]. Blood. 2015;126:3511.
- Kavakli KO AF, Celkan T, Timur C, et al. Use of a high-purity factor X (FX) concentrate in six Turkish patients with hereditary FX deficiency [abstract]. Haemophilia. 2016;22:S2.
- Kulkarni R, James A, Norton M, et al. Pharmacokinetics, safety, and efficacy of a new high-purity plasma-derived factor X concentrate in female subjects with hereditary factor X deficiency [abstract]. Haemophilia. 2016;22(Suppl 4):136.
- Lloyd J, John E, Feldman P. In-vitro immunogenicity studies of a new high purity factor X concentrate [abstract]. Haemophilia. 2010;16:37–38. 08P24.
- Lloyd J, Feldman P, Ryan L. In vitro reversal of the direct Xa inhibitor rivaroxaban using high-purity factor X concentrate (factor X) [abstract]. Haemophilia. 2012;18:33. PO-TU-033.
- Kouides PA, Kulzer L. Prophylactic treatment of severe factor X deficiency with prothrombin complex concentrate. Haemophilia. 2001;7:220–223.