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Thromb Haemost 2008; 99(05): 851-862
DOI: 10.1160/TH07-10-0592
Theme Issue Article
Schattauer GmbH

Plasma-derived biological medicines used to promote haemostasis

Frederick A. Ofosu
1   Canadian Blood Services and Department of Pathology & Molecular Medicine, McMaster University, Hamilton, Ontario, Canada
,
John Freedman
2   Department of Laboratory Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
,
John W. Semple
2   Department of Laboratory Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
› Author Affiliations
Further Information

Publication History

Received 04 October 2007

Accepted after major revision 13 March 2008

Publication Date:
30 November 2017 (online)

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Summary

Several biological medicines derived from human and animal plasmas can effectively improve haemostasis in individuals with inherited or acquired defects in haemostasis. Factor VIII and factor VIII/vWF and factor IX concentrates are used to treat haemophilia A, von Willebrand disease and hemophilia B respectively. Cryoprecipitates are used to treat hypofibrinogenemia and von Willebrand disease where desmopressin (DDAVP) is ineffective or when plasma-derived factor VIII/vWF concentrates are unavailable. Thrombin-containing topical haemostatic agents and fibrin sealants are used to control perioperative bleeding. Intravenous immunoglobulin has several uses, including management of patients with autoimmune thrombocytopenias and patients with acquired factor VIII deficiency. Similar to most protein- based biological medicines, all the above products can elicit some level of antibody response, with clinical consequences that vary from mild anaphylaxis to loss of product efficacy. An ongoing potential safety concern with any biological medicine derived from blood/plasma is transmission of blood-borne pathogens. This safety concern has lessened significantly in the past decade as a result of the institution of more effective pre- and post-donation screening that tests for potential pathogens, and institution of pathogen reduction strategies to which many plasma-derived biological medicines are now routinely subjected. This article considers the manufacture, standardization, clinical efficacy and adverse event profiles of the plasma-derived biological medicines currently used to promote haemostasis in patients with inherited or acquired functional defects in haemostasis. It also considers approaches employed to minimize infectivity of biological medicines derived from human and animal plasmas and to manage patients who develop antibodies (inhibitors) to clotting factor concentrate infusions.

Keywords

Adverse events - biological medicines - cryoprecipitate - factor VIII - factor IX - haemostasis - IVIG - thrombin
 

  • References

  • 1 Shankar G, Pendley C, Stein KE. A risk-based bioanalytic strategy for the assessment of antibody responses against biological drugs. Nat Biotechol 2007; 25: 555-561.
    CrossrefPubMedGoogle Scholar
  • 2 Chamberlain P, Mire-Sluis AR. An overview of scientific and regulatory issues for the immunogenicity of biological products. Dev Biol 2003; 112: 3-11.
    PubMedGoogle Scholar
  • 3 Chalmers EA, Brown SA, Keeling D. et al. Early factor VIII exposure and subsequent inhibitor development in children with severe haemophilia A. Haemophilia 2007; 13: 149-155.
    CrossrefPubMedGoogle Scholar
  • 4 Schellekens H. Immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2003; 8: 1257-1259.
    PubMedGoogle Scholar
  • 5 Lamm P, Adelhard K, Juchem G. et al. Fibrin glue in coronary artery bypass grafting procedures: casting out the Devil with Beelzebub. Eur J Cardio Thorac Surg 2007; 32: 567-572.
    CrossrefPubMedGoogle Scholar
  • 6 Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2005; 20 (Suppl. 06) vi3-9.
    CrossrefPubMedGoogle Scholar
  • 7 Porter S. Human immune response to recombinant human proteins. J Pharm Sci 2001; 90: 1-11.
    CrossrefPubMedGoogle Scholar
  • 8 Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans – clinical significance, assessment and prediction. Curr Pharm Biotechnol 2002; 3: 349-360.
    CrossrefPubMedGoogle Scholar
  • 9 Reeves WG. The immune response to insulin: characterisation and clinical consequences. Diabetes Annual 2.. Amsterdam: Elsevier; 1986
    Google Scholar
  • 10 Stubbe P. In: Incidence of growth hormone antibodies and presumed growth-attenuating antibodies in relation to various pituitary growth hormone preparations.. Munich: Urban & Schwarzenberg; 1993: 92-99.
  • 11 Palleroni AV, Aglione A, Baillon P. et al. Interferon immunogenicity: preclinical evaluation of interferon-interferon-α2a. J Int Cytokine Res 1997; 7: S23-27.
    PubMedGoogle Scholar
  • 12 Klein HG. Pathogen inactivation technology: cleansing the blood supply. J Intern Med 2004; 257: 224-237.
    PubMedGoogle Scholar
  • 13 Cai K, Gierman TM, Hotta J. et al. Ensuring the biologic safety of plasma-derived therapeutic proteins. Detection, inactivation, and removal of pathogens. Biodrugs 2005; 19: 79-96.
    CrossrefPubMedGoogle Scholar
  • 14 Food and Drug Administration.. Guide to inspections of viral clearance processes for plasma derivatives. Available at: www.fda.gov/ora/inspect_ref/igs/viralcl.html. Accessed 18 April 2007.
    PubMedGoogle Scholar
  • 15 Kumar A, Kulkarni R, Murray DL. et al. Serologic markers of viral hepatitis A, B, C, and D in patients with hemophilia. J Med Virol 1993; 41: 205-209.
    CrossrefPubMedGoogle Scholar
  • 16 Skidmore SJ, Pasi KJ, Mawson SJ. et al. Serological evidence that dry heating of clotting factor concentrates prevents transmission of non-A, non-B hepatitis. J Med Virol 1990; 30: 50-52.
    CrossrefPubMedGoogle Scholar
  • 17 Aledort LM, Levine PH, Hilgartner M. et al. A study of liver biopsies and liver disease among hemophiliacs. Blood 1985; 66: 367-372.
    PubMedGoogle Scholar
  • 18 Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion 1999; 39: 1160-1168.
    CrossrefPubMedGoogle Scholar
  • 19 Burnouf T, Radosevich M. Nanofiltration of plasma- derived biopharmaceutical products. Haemophilia 2003; 9: 24-37.
    CrossrefPubMedGoogle Scholar
  • 20 Committee for Human Medicinal Products (CPMP).. Core SPC for human plasma- derived and recombinant coagulation factor VIII products.. London: European Agency for the Evaluation of Medicinal Products; 2000
  • 21 Chtourou S, Porte P, Nogre M. et al. A solvent/detergent- treated and 15 nm filtered factor VIII: a new safety standard for pharma-derived coagulation factor concentrates. Vox Sang 2007; 92: 327-337.
    PubMedGoogle Scholar
  • 22 Burdick MD, Pifat DY, Petteway SR. Jr et al. Clearance of prions during plasma protein manufacture. Transfusion Med Rev 2006; 20: 57-62.
    CrossrefPubMedGoogle Scholar
  • 23 Scandella D, Gilbert GE, Shima M. et al. Some factor VIII inhibitor antibodies recognise a common epitope corresponding to C2 domain amino acids 2248 through 2312, which overlap a phospholipid-binding site. Blood 1995; 86: 1811-1819.
    PubMedGoogle Scholar
  • 24 Scandella DH, Nakai H, Felch M. et al. In hemophilia A and autoantibody inhibitor patients: the factor VIII A2 domain and light chain are most immunogenic. Thromb Res 2001; 101: 377-385.
    CrossrefPubMedGoogle Scholar
  • 25 Lacroix-Desmazes S, Misra N, Bayry J. et al. Autoantibodies to factor VIII. Autoimmunity Rev 2002; 1: 105-110.
    CrossrefPubMedGoogle Scholar
  • 26 The Haemophilia Society.. An introduction to haemophilia and related bleeding disorders.. London: The Haemophilia Society; 2004
  • 27 Chandra S, Groener A, Feldman F. Effectiveness of alternative treatments for reducing portenilal viral contaminants from plasma-derived products. Thromb Res 2002; 105: 391-400.
    CrossrefPubMedGoogle Scholar
  • 28 Baxter Healthcare.. Hemofil M. Antihemophilic factor (human): method M, monoclonal purified.. Westlake Village, CA, USA: Baxter Healthcare Corporation; 2002
  • 29 ZLB Behring LLC.. Antihemophilic factor (human): Monoclate-P®.. Kankakee, IL: ZLB Behring LLC; 2004
  • 30 Peerlinck K, Hermans C. Epidemiology of inhibitor formation with recombinant factor VIII replacement therapy. Haemophilia 2006; 12: 579-590.
    CrossrefPubMedGoogle Scholar
  • 31 European Agency for the Evaluation of Medicinal Products.. Report of expert meeting on factor VIII products and inhibitor development.. London: European Agency for the Evaluation of Medicinal Products; 2007
  • 32 Key NS. Inhibitors in congenital coagulation disorders. Br J Haematol 2004; 127: 379-391.
    CrossrefPubMedGoogle Scholar
  • 33 Bohn RL, Aledort LM, Putnam KG. et al. The economic impact of factor VIII inhibitors in patients with haemophilia. Haemophilia 2004; 10: 63-68.
    PubMedGoogle Scholar
  • 34 Tamura K, Kanazawa T, Suzuki M. et al. Successful induction of immune tolerance by continuous infusion of recombinant factor VIII in a haemophilia A patient with high inhibitor titres. Haemophilia 2006; 12: 100-102.
    CrossrefPubMedGoogle Scholar
  • 35 Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia 2003; 9: 418-435.
    CrossrefPubMedGoogle Scholar
  • 36 Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol 2004; 251 (Suppl. 02) II/4-9.
    PubMedGoogle Scholar
  • 37 Holme PA, Brosstad F, Tjønnfjord GE. Acquired haemophilia: management of bleeds and immune therapy to eradicate autoantibodies. Haemophilia 2005; 11: 510-515.
    CrossrefPubMedGoogle Scholar
  • 38 Hay CR, Negrier C, Ludlam CA. The treatment of bleeding in acquired haemophilia with recombinant factor VIIa: a multicentre study. Thromb Haemost 1997; 78: 1463-1467.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 39 Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP. et al. The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med 1981; 305: 717-721.
    CrossrefPubMedGoogle Scholar
  • 40 Negrier C, Goudemand J, Sultan Y. et al. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. Thromb Haemost 1997; 77: 1113-1119.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 41 Yee TT, Taher A, Pasi KJ, Lee CA. A survey of patients with acquired haemophilia in a haemophilia centre over 28-year period. Clin Lab Haem 2000; 22: 275-278.
    CrossrefPubMedGoogle Scholar
  • 42 Grünewald M, Beneke H, Guthner C. et al. Acquired haemophilia: experiences with a standardized approach. Haemophilia 2001; 7: 164-169.
    CrossrefPubMedGoogle Scholar
  • 43 Sallah S. Treatment of acquired haemophilia with factor eight inhibitor bypassing activity. Haemophilia 2004; 10: 169-173.
    CrossrefPubMedGoogle Scholar
  • 44 The Haemophilia Society.. Inhibitors.. London: The Haemophilia Society; 2005
  • 45 Chang H, Mody M, Lazarus AH. et al. Platelet activation induced by porcine factor VIII (HYATE:C). Am J Hematol 1998; 57: 200-205.
    CrossrefPubMedGoogle Scholar
  • 46 Freedman J, Rand ML, Russell O. et al. Immunoadsorption provides a cost-effective approach to management of patients with inhibitors to factor VIII. Transfusion 2003; 43: 1508-1513.
    CrossrefPubMedGoogle Scholar
  • 47 Freedman J, Garvey MB. Immunoadsorption of factor VIII inhibitors. Curr Opin Hematol 2004; 11: 327-333.
    CrossrefPubMedGoogle Scholar
  • 48 Tjønnfjord GE. Activated prothrombin complex concentrate (FEIBA®) treatment during surgery in patients with inhibitors to FVIII/IX: the updated Norwegian experience. Haemophilia 2004; 10 (Suppl. 02) 41-45.
    PubMedGoogle Scholar
  • 49 Luu H, Ewenstein B. FEIBA® safety profile in multiple modes of clinical and home-therapy application. Haemophilia 2004; 10 (Suppl. 02) 10-16.
    CrossrefPubMedGoogle Scholar
  • 50 Astermark J, Donfield SM, DiMichele DM. et al. A randomised comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA Novo- Seven Comparative Study. Blood 2007; 109: 546-551.
    CrossrefPubMedGoogle Scholar
  • 51 Astermark J, Rocino A, von Depka M. et al. Current use of by-passing agents in Europe in the management of acute bleeds in patients with haemophilia and inhibitors. Haemophilia 2007; 13: 38-45.
    PubMedGoogle Scholar
  • 52 Mannucci PM, Abshire T, DiMichele D. et al. Inhibitor development, immune tolerance and prophylaxis in haemophilia A – the need for an evidence-based approach. Haemophilia 2006; 12: 429-434.
    CrossrefPubMedGoogle Scholar
  • 53 Mariani G, Kroner B. International immune tolerance registry, 1997 update. Vox Sang 1999; 77 (Suppl) 25-27.
    CrossrefPubMedGoogle Scholar
  • 54 Lenk H. The German registry of immune tolerance treatment in haemophilia–1999 update. Haematologica 2000; 85 (Suppl) 45-47.
    PubMedGoogle Scholar
  • 55 DiMichele D, Droner B. The maintenance of tolerance after successful immune tolerance induction in hemophilia A and B: the North American Registry. Haematologica 2000; 85 (Suppl) 40-42.
    PubMedGoogle Scholar
  • 56 Hodge G, Saxon B, Revesz T. Effect of factor VIII concentrate on leucocyte cytokine receptor expression in vitro: relevance to inhibitor formation and tolerance induction. Haemophilia 2006; 12: 133-139.
    PubMedGoogle Scholar
  • 57 Ettingshausen CE, Kreuz W. Role of von Willebrand factor in immune tolerance induction. Blood Coagul Fibrinolysis 2005; 16 (Suppl) S27-31.
    CrossrefPubMedGoogle Scholar
  • 58 Kreuz W. Immune tolerance induction (ITI) in haemophilia A patients with inhibitors as the choice of concentrate affecting success. Haematologica 2001; 86: 16-20.
    PubMedGoogle Scholar
  • 59 Mannucci PM, Gringeri A, Peyvandi F, Santagostino E. Factor VIII products and inhibitor developement: the SIPPET Study (survey of inhibitors in plasmaproducts exposed to toddlers). Haemophilia 2007; 13 (Suppl. 05) 65-68.
    PubMedGoogle Scholar
  • 60 Goudemand J. Inhibitor development in haemophilia A: the role of von Willebrand factor/factor VIII concentrates. Haemophilia 2007; 13 (Suppl. 05) 47-51.
    PubMedGoogle Scholar
  • 61 Greninger DA, Saint-Remy JM, Jacquemin M. et al. The use of factor VIII/von Willebrand factor concentrate for immune tolerance induction in haemophilia A patients with high-titre inhibitors: association of clinical outcome with inhibitor profile. Haemophilia. 2007 epub ahead of print.
    PubMedGoogle Scholar
  • 62 Kurth MA, Dicmichele D, Sexauer C. et al. Immune tolerance therapy utilizing factor VIII/von Willebrand factor concentrate in haemophilia A patients with high titre factor VIII inhibitors. Haemophilia 2007; 14: 5-55.
    CrossrefPubMedGoogle Scholar
  • 63 Gringeri A, Musso R, Mazzucconi MG. et al. RITS-FITNESS Study Group. Immune tolerance induction with a high purity von Wiollebrand factor/factor VIII complex concentrate in haemophilia A patients with inhibitors at high risk of poor response. Haemophilia 207 13: 373-379.
    PubMedGoogle Scholar
  • 64 Goudemand J, Peyneet J, Chambost H. et al. A cross-over pharmacokinetic study of a double viral inactivated factor IX concentrate (15 nm filtration and SD) compared to a SD factor IX concentrate. Thromb Haemost 1998; 80: 919-924.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 65 Burnouf T, Michalsk C, Goudemand M. et al. Properties of highly purified human plasma factor IX:C therapeutic concentrate prepared by conventional chromatography. Vox Sang 1989; 57: 225-232.
    PubMedGoogle Scholar
  • 66 Pipe S. Recombinant clotting factors. Thromb Haemost 2008; 99: 840-850.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 67 Hampton KK, Preston FE, Lowe GDO. et al. Reduced coagulation activation following infusion of a highly purified factor IX concentrate compared to a prothrombin complex concentrate. Br J Haematol 1993; 84: 274-284.
    PubMedGoogle Scholar
  • 68 Committee for Proprietary Medicinal Products (CPMP).. Core SPC for human plasma derived and recombinant coagulation factor IX products.. London: European Agency for the Evaluation of Medicinal Products; 2000
  • 69 Lawlor E, Graham S, Davidson F. et al. Hepatitis A transmission by factor IX concentrates. Vox Sang 1996; 71: 126-128.
    CrossrefPubMedGoogle Scholar
  • 70 Schulman S, Wallensten R, White B. et al. Efficacy of a high purity, chemically treated and nanofiltered factor IX concentrate for continuous infusion in haemophilia patients undergoing surgery. Haemophilia 1999; 5: 96-100.
    CrossrefPubMedGoogle Scholar
  • 71 Evans G, Collett M, Came N. et al. MonoFIX-VF, a new mono-component factor IX concentrate: a singlecentre continuous-infusion study. Haemophilia 2002; 8: 635-638.
    CrossrefPubMedGoogle Scholar
  • 72 Zakarija A. Factor IX replacement in surgery and prophylaxis. Blood Coagul Fibrinolysis 2004; 15 (Suppl. 02) S5-7.
    CrossrefPubMedGoogle Scholar
  • 73 Ewenstein BM, Joist JH, Shapiro AD. et al. Pharmacokinetic analysis of plasma-derived and recombinant factor IX concentrates in previously treated patients with moderate or severe hemophilia B. Transfusion 2002; 42: 190-197.
    CrossrefPubMedGoogle Scholar
  • 74 Parquet A, Laurian Y, Rothschild C. et al. Incidence of factor IX inhibitor development in severe haemophilia B patients treated with only one brand of high purity plasma derived factor IX concentrate. Thromb Haemost 1999; 82: 1247-1249.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 75 Ruiz-Sáez A, Hong A, Arguello A. et al. Pharmacokinetics, thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a prothrombin complex concentrate. Haemophilia 2005; 11: 583-588.
    CrossrefPubMedGoogle Scholar
  • 76 Lopez-Plaza I. Cryoprecipitate component characteristics: its uses and complications. Transfusion Medicine Update 1995;. March: 1–3. Available at: www.itxm.org/tmu1995/tmu3–95.htm. Accessed April 22, 2007.
    PubMedGoogle Scholar
  • 77 Federici AB, Castaman G, Franchini M. et al. Clinical use of Haemate P in inherited von Willebrand’s disease: a cohort study of 100 Italian patients. Haematologica 2007; 92: 944-995.
    CrossrefPubMedGoogle Scholar
  • 78 Favaloro EJ, Lloyd J, Rowell J. et al. Comparison of the pharmacokinetics of two von Willebrand factor concentrates [Biostate and AHF (High Purity)] in people with von Willebrand disorder. A randomized cross-over, multicentre study. Thromb Haemost 2007; 97: 922-930.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 79 Kelley DL. Update on plasma and cryoprecipitate infusion. Transfusion Medicine Update 2004; 1: 1-4. Available at: www.itxm.org/tmu2004/issue2004–1.htm. Accessed August 7, 2007.
    PubMedGoogle Scholar
  • 80 Mannucci PM, Bauer KA, Santagostino E. et al. Activation of coagulation cascade after infusion of factor XI concentrate in congenitally deficient patients. Blood 1994; 84: 1314-1319.
    PubMedGoogle Scholar
  • 81 Blanchard N, Jeanjean P, Lapoointe F. et al. Factor XI deficiency, a new way of substitution: human purified concentrate. Ann Fr Anesth Reamin 1996; 15: 1207-1210.
    PubMedGoogle Scholar
  • 82 Richards EM, Markis MM, Cooper P. et al. In vivo coagulation activation following infusion of highly purified factor XI concentrates. Br J Haematol 1997; 96: 293-297.
    PubMedGoogle Scholar
  • 83 Solomon O, Seligsohn U. New observations on factor XI deficiences. Haemophilia 2004; 10 (Suppl. 04) 184-187.
    CrossrefPubMedGoogle Scholar
  • 84 Lawler P, White B, Pye S. et al. Successful use of recombinant factor VIIa in a patient with inhibitor secondary to severe factor XI deficiency. Haemophilia 2002; 8: 145-148.
    CrossrefPubMedGoogle Scholar
  • 85 Winkelman L, Sims GE, Haddon ME. et al. A pasteurized concentrate of human plasma factor XIII for therapeutic use. Thromb Haemost 1996; 55: 402-405.
    PubMedGoogle Scholar
  • 86 Daly HM, Haddon ME. Clinical experience with a pasteurized human plasma concentrate in factor XIII deficiency. Thromb Haemost 1988; 59: 171-174.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 87 Gootenberg JE. Factor concentrates for the treatment of factor XIII deficiency. Curr Opin Hematol 1998; 5: 372-375.
    CrossrefPubMedGoogle Scholar
  • 88 Tomizawa Y. Clinical benefits and risk analysis of topical hemostats: a review. J Artif Organs 2005; 8: 137-142.
    CrossrefPubMedGoogle Scholar
  • 89 Canonico S. The use of human fibrin glue in the surgical operations. Acta Biomed 200; 74 (Suppl. 02) 21-25.
    PubMedGoogle Scholar
  • 90 Jackson MR, MacPhee MJ, Drohan WM. et al. Fibrin sealant current and potential clinical applications. Blood Coagul Fibrinolysis 1996; 7: 737-746.
    CrossrefPubMedGoogle Scholar
  • 91 Mintz PD, Mayers L, Avery N. et al. Fibrin sealant: clinical use and the development of the University of Virginia Tissue Adhesive Center. Ann Clin Lab Sci 2001; 31: 108-118.
    PubMedGoogle Scholar
  • 92 Muntean W, Zanz W, Edinger C. et al. Severe bleeding due to factor V inhibitor after repeated operations using fibrin sealant containing bovine thrombin. Thromb Haemost 1997; 77: 1233.
    PubMedGoogle Scholar
  • 93 Nelson PA, Powers JN, Estridge TF. et al. Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma. J Biomed Mater Res 2001; 58: 710-719.
    CrossrefPubMedGoogle Scholar
  • 94 Schoenecker JG, Johnson RK, Fields RC. et al. Relative purity of thrombin-based hemostatic agents used in surgery. J Am Coll Surg 2003; 197: 580-590.
    CrossrefPubMedGoogle Scholar
  • 95 Lawson JH. The clinical use and immunological impact of thrombin in surgery. Semin Thromb Hemost 2006; 32 (Suppl. 01) 98-100.
    PubMedGoogle Scholar
  • 96 Evithrom® Prescribing Information.. Kiryat Ono. Israel: OMRIX biopharmaceuticals Ltd.; 2007
  • 97 Chapman WC, Singla N, Genyk Y. et al. A phase 3, randomized double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg 2007; 206: 256-265.
    PubMedGoogle Scholar
  • 98 Gabay M. Absorbable haemostatic agents. Am J Health-Syst Pharm 2006; 63: 1244-1253.
    PubMedGoogle Scholar
  • 99 Jenny R, Church W, Odegaard B. et al. Purification of six human vitamin K-dependent proteins in a single chromatographic step using immunoaffinity columns. Prep Biochem 1986; 16: 227-245.
    PubMedGoogle Scholar
  • 100 Flengsrud R. Purification and some characteristics of the human coagulation factor VII. Eur J Biochem 1979; 98: 455-464.
    CrossrefPubMedGoogle Scholar
  • 101 Suomela H, Myllyla G, Raaska E. Preparation and properties of a therapeutic factor IX concentrate. Vox Sang 1977; 33: 37-50.
    CrossrefPubMedGoogle Scholar
  • 102 Lawson JH, Kalafatis M, Stram S. et al. A model for the tissue factor pathway to thrombin. 1. An empirical study. J Biol Chem 1994; 269: 23357-23366.
    PubMedGoogle Scholar
  • 103 Radcliffe RD, Barton PG. Comparisons of the molecular forms of activated bovine factor X. Properties of activation with Russell’s viper venom, insoluble trypsin, sodium citrate, tissue factor, and the intrinsic system. J Biol Chem 1973; 248: 6788-6795.
    PubMedGoogle Scholar
  • 104 Lundblad RL. A rapid method for the purification of bovine thrombin and inhibition of the purified enzyme with phenylmethylsulfonyl fluoride. Biochemistry 1971; 10: 2501-2506.
    CrossrefPubMedGoogle Scholar
  • 105 Church FC, Winna HC. Rapid sulfopropyl-disk chromatographic purification of bovine and human thrombin. Anal Biochem 1986; 157: 77-83.
    CrossrefPubMedGoogle Scholar
  • 106 Griffith MJ. Covalent modification of human alpha-thrombin with pyrioxal-5’-phosphate. Effect of phosphopyridoxylation on the interaction of thrombin with heparin. J Biol Chem 1979; 254: 3401-3406.
    PubMedGoogle Scholar
  • 107 Ortel TL, Mercer MC, Thames EH, Moore KD, Lawson JH. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg 2001; 233: 88-96.
    CrossrefPubMedGoogle Scholar
  • 108 Ortel TL, Charles LA, Keller FG. et al. Topical thrombin and acquired coagulation factor inhibitors: clinical spectrum and laboratory diagnosis. Am J Hematol 1994; 45: 128-135.
    CrossrefPubMedGoogle Scholar
  • 109 Streiff MB, Ness PM. Acquired FV inhibitors: a needless iatrogenic complication of bovine thrombin exposure. Transfusion 2002; 42: 18-26.
    CrossrefPubMedGoogle Scholar
  • 110 Winterbottom N, Kuo JM, Nguyen K. et al. Antigenic response to bovine thrombin exposure during surgery: a prospective study of 309 patients. J Appl Res Clin Exp Ther 2002; 2: 1-12.
    PubMedGoogle Scholar
  • 111 Schoenecker JG, Hauck RK, Mercer MC. et al. Exposure to topical bovine thrombin during surgery elicits a response against the xenogeneic carbohydrate galactose alpha1–3galactose. J Clin Immunol 2000; 20: 434-444.
    CrossrefPubMedGoogle Scholar
  • 112 Imbach P, Barandun S, d’Apuzzo V. et al. High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet 1981; 1: 1228-1231.
    PubMedGoogle Scholar
  • 113 Pirofsky B, Kinzey DM. Intravenous immune globulins: a review of their uses in selected immunodeficiency and autoimmune disease. Drugs 1992; 43: 6-14.
    PubMedGoogle Scholar
  • 114 Consensus Working Group.. Present and future uses of intravenous immune globulin (IVIG). A Canadian multidisciplinary consensus-building initiative.. Toronto: Maclean Hunter Healthcare Santé: 1997
  • 115 Robinson P, Anderson D, Brouwers M. et al. Evidence- based guidelines on the use of intravenous immune globulin for hematologic and neurologic conditions. Transfus Med Rev 2007; 21 (Suppl. 01) S3-8.
    CrossrefPubMedGoogle Scholar
  • 116 Anderson D, Ali K, Blanchette V. et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev 2007; 21 (Suppl. 01) S9-56.
    CrossrefPubMedGoogle Scholar
  • 117 Feasby T, Banwell B, Benstead T. et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev 2007; 21 (Suppl. 01) S57-107.
    CrossrefPubMedGoogle Scholar
  • 118 Roussell RH, Pennington JE. An historical overview of immunoglobulin therapy. Peng LY. ed. Clinical applications of intravenous immunoglobulin therapy.. New York: Churchill Livingstone; 1992
    Google Scholar
  • 119 Bril V, Allenby K, Midroni G. et al. IGIV in neurology – evidence and recommendations. Can J Neurol Sci 1999; 26: 139-152.
    PubMedGoogle Scholar
  • 120 Barandum S, Kistler P, Jeunet F. et al. Intravenous administration of human g-globulin. Vox Sang 1962; 7: 157-174.
    CrossrefPubMedGoogle Scholar
  • 121 Infectious Diseases and Immunization Committee, Ottawa, Ontario, Canada.. Intravenous immune globulin use in children. Can Med Assoc J 1992; 146: 121-124.
    PubMedGoogle Scholar
  • 122 Lee D, Remington KM, Petteway SR. Production of intravenous immunoglobulin and other plasma-derived products. J Intravenous Nursing 2000; 23 (Suppl. 05) S18-22.
    PubMedGoogle Scholar
  • 123 Miller JLC, Petteway SR, Lee DC. Ensuring the pathogen safety of intravenous immunoglobulin and other human plasma-derived therapeutic proteins. J Allergy Clin Immunol 2001; 108: S91-94.
    CrossrefPubMedGoogle Scholar
  • 124 Lemm G. Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy. Neurology 2002; 59 (Suppl. 06) S28-32.
    CrossrefPubMedGoogle Scholar
  • 125 Lundblad JL, Seng RL. Inactivation of lipid-enveloped viruses in proteins by caprylate. Vox Sang 1991; 60: 75-81.
    CrossrefPubMedGoogle Scholar
  • 126 Korneyeva M, Hotta J, Lebing W. et al. Enveloped virus inactivation by caprylate: a robust alternative to solvent-detergent treatment. Biologicals 2002; 30: 153-162.
    CrossrefPubMedGoogle Scholar
  • 127 Mitra G, Dobkin M. Inactivation of viruses during preparation of immunoglobulins in biotechnology of plasma proteins.. Paris: Colloques Inserm; 1989: 405-412.
  • 128 Bos OMB, Sunye DGJ, Nieuweboer CEF. et al. Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process. Biologicals 1998; 26: 267-276.
    CrossrefPubMedGoogle Scholar
  • 129 Reid KG, Cuthbertson B, Jones ADL. et al. Potential contribution of mild pepsin treatment at pH 4 to the viral safety of human immunoglobulin products. Vox Sang 1988; 55: 75-80.
    CrossrefPubMedGoogle Scholar
  • 130 Lazarus AH, Crow AR. Mechanism of action of IVIG and anti-D in ITP. Transfusion Apheresis Sci 2003; 28: 249-255.
    CrossrefPubMedGoogle Scholar
  • 131 Siegel J. Viral safety issues in IVIG products. P & T. 1996: 21S-24S.
    PubMedGoogle Scholar
  • 132 World Health Organization.. Appropriate use of human immunoglobulin in clinical practice: memorandum from an IUIS/WHO meeting. Bull WHO 1982; 60: 43-47.
    PubMedGoogle Scholar
  • 133 Hetherington SV, Giebink GS. Opsonic activity of immunoglobulin prepared for intravenous use. J Lab Clin Med 1984; 104: 977-986.
    PubMedGoogle Scholar
  • 134 Schoeder DD, Tankersley DL, Lundblad JL. A new preparation of modified immune serum globulin (human) suitable for intravenous administration. II. Functional characterization. Vox Sang 1981; 40: 383-394.
    CrossrefPubMedGoogle Scholar
  • 135 Sultan Y, Kazatchkine MD, Maisonneuve P. et al. Anti-idiotypic suppression of autoantibodies to factor VIII (antihaemophilic factor) by high-dose intravenous gammaglobulin. Lancet 1984; 2: 765-768.
    PubMedGoogle Scholar
  • 136 Sultan Y, Rossi F, Kazatchkine M. Anti idiotypic recognition of auto and allo antibodies to factor VIII by immunoglobulin preparations from single blood donors and large plasma pool. Folia Haematol Int Mag Klin Morph Blutforsch 1990; 117: 539-543.
    PubMedGoogle Scholar
  • 137 Sultan Y, Kazatchkine MD, Nydegger U. et al. Intravenous immunoglobulin in the treatment of spontaneously acquired factor VIII:C inhibitors. Am J Med 1991; 91: 355-395.
    CrossrefPubMedGoogle Scholar
  • 138 Sultan Y, Nydegger U, Kazatchkine MB. et al. IVIg in the treatment of patients with factor VIII inhibitors. Adv Exp Med Biol 1995; 386: 185-189.
    PubMedGoogle Scholar
  • 139 Dietrich G, Algiman M, Sultan Y. et al. Origin of anti-idiotypic activity against anti-factor VIII antibodies in pools of normal human immunoglobulin G (IVIg). Blood 1992; 79: 2946-2951.
    PubMedGoogle Scholar
  • 140 Schwartz RS, Gabriel DA, Aledort LM. et al. A prospective study of treatment of acquired (autoimmune) factor VIII inhibitors with high-dose intravenous immunoglobulin. Blood 1995; 86: 797-804.
    PubMedGoogle Scholar
  • 141 Yamamoto K, Takamatsu J, Saito H. Intravenous immunoglobulin therapy for acquired coagulation inhibitors: a critical review. Int J Hematol 2007; 85: 287-293.
    CrossrefPubMedGoogle Scholar
  • 142 Di Giambattista M, Brankaert T, Lamb R. Mapping of natural anti-factor VIII antibodies in plasma pools from healthy donors: use of rationally designed synthetic peptides. Biologicals 2001; 29: 229-232.
    CrossrefPubMedGoogle Scholar
  • 143 Algiman M, Dietrich G, Nydegger VE. et al. Natural antibodies to factor VIII (anti-hemophilic factor) in healthy individuals. Proc Natl Acad Sci USA 1992; 89: 3795-3799.
    CrossrefPubMedGoogle Scholar
  • 144 Salama A, Kiefel V, Amber R. et al. Treatment of autoimmune thrombocytopenic purpura with rhesus antibodies (anti-Rh0(D)). Blut 1984; 49: 29-35.
    CrossrefPubMedGoogle Scholar
  • 145 Scaradavou A, Woo B, Woloski BMR. et al. Intravenous anti-D treatment of immune thrombocytopenic purpura: experience in 272 patients. Blood 1997; 89: 2689-2700.
    PubMedGoogle Scholar
  • 146 Gelfand EW. Antibody-directed therapy: past, present and future. J Allergy Clin Immunol 2001; 108: S111-116.
    CrossrefPubMedGoogle Scholar
  • 147 Bayry J, Lacroix-Desmazes S, Carbonneil C. et al. Inhibition of maturation and function of dendritic cells by intravenous immunoglobulin. Blood 2003; 101: 758-765.
    CrossrefPubMedGoogle Scholar
  • 148 Kaveri SV, Mouthon L, Kazatchkine MD. Immunomodulating effects of intravenous immunoglobulin in autoimmune and inflammatory diseases. J Neurol Neurosurg Psychiatry 1994; 57 (Suppl) 6-8.
    CrossrefPubMedGoogle Scholar
  • 149 Aktas O, Waiczies S, Grieger U. et al. Polyspecific immunoglobulins (IVIg) suppress proliferation of human (auto)antigen-specific T cells without inducing apoptosis. J Neuroimmunol 2001; 114: 160-167.
    CrossrefPubMedGoogle Scholar
  • 150 Nakatani K, Takeshita S, Thusjimoto H. et al. Intravenous immunoglobulin (IVIG) preparations induce apoptosis in TNF-a-stimulated endothelial cells via a mitochondria-dependent pathway. Clin Exp Immunol 2002; 127: 445-454.
    CrossrefPubMedGoogle Scholar
  • 151 Kazatchkine MD, Kaveri SV. Immunomodulation of autoimmune and inflammatory diseases with intravenous immune globulin. N Engl J Med 2001; 345: 747-755.
    CrossrefPubMedGoogle Scholar
  • 152 Larroche C, Chanseaud Y, de la Pena-Lefebvre PG. et al. Mechanisms of intravenous immunoglobulin action in the treatment of autoimmune disorders. Biodrugs 1992; 16: 47-55.
    PubMedGoogle Scholar
  • 153 Salama A, Mueller-Eckhardt C, Kiefel V. Effect of intravenous immunoglobulin in immune thrombocytopenia. Lancet 1983; 2: 193-195.
    PubMedGoogle Scholar
  • 154 Samuelsson A, Towers TL, Ravetch JV. Anti-inflammatory activity of IVIG mediated through the inhibitory Fc receptor. Science 2001; 291: 484-486.
    CrossrefPubMedGoogle Scholar
  • 155 Semple JW, Allen D, Rutherford M. et al. Anti-D (WinRho SDTM) treatment of children with chronic autoimmune thrombocytopenic purpura stimulates transient cytokine/chemokine production. Am J Hematol 2002; 69: 225-227.
    CrossrefPubMedGoogle Scholar
  • 156 Coopamah MD, Freedman J, Semple JW. Anti-D (WinRho®SDF) initially stimulates an Fc-dependent leukocyte oxidative burst and subsequently suppresses erythrophagocytosis via interleukin 1 receptor antagonist. Blood 2003; 102: 2862-2867.
    CrossrefPubMedGoogle Scholar
  • 157 Siragam V, Brinc D, Crow AR. et al. Can antibodies with specificity for soluble antigens mimic the therapeutic effects of intravenous immunoglobulin in the treatment of autoimmune disease?. J Clin Invest 2005; 115: 155-160.
    CrossrefPubMedGoogle Scholar
  • 158 Webster ML, Sayeh E, Crow M. et al. Relative efficacy of intravenous immunoglobulin G in ameliorating thrombocytopenia induced by anti-platelet GPIIbIIIa versus GPIba antibodies. Blood 2006; 108: 943-946.
    CrossrefPubMedGoogle Scholar
  • 159 Song S, Crow AR, Siragam V. et al. Monoclonal antibodies that mimic the action of anti-D in the amelioration of murine ITP act by a mechanism distinct from that of IVIG. Blood 2005; 105: 1546-1548.
    CrossrefPubMedGoogle Scholar
  • 160 British Columbia Provincial Blood Coordinating Office.. IVIG Utilization Management Handbook.. Vancouver: British Colombia Provincial Blood Coordinating Office; 2002
  • 161 Kim HC, Park CL, Cowan JH. et al. Massive intravascular hemolysis associated with intravenous immunoglobulin in bone marrow transplant recipients. Am J Pediatr Hematol Oncol 1988; 10: 69-74.
    CrossrefPubMedGoogle Scholar
  • 162 Gaines AR. Acute onset hemoglobinemia and/or hemoglobinuria and sequelae following Rho(D) immune globulin intravenous administration in immune thrombocytopenic purpura patients. Blood 2000; 95: 2523-2529.
    PubMedGoogle Scholar
  • 163 Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood 2005; 106: 1532-1537.
    CrossrefPubMedGoogle Scholar
  • 164 Tarantino M, Bussel JB, Cines DB. et al. A closer look at intravascular hemolysis (IVH) following intravenous anti-D for immune thrombocytopenic purpura (ITP). Blood 2007; 109: 5527.
    CrossrefPubMedGoogle Scholar