Stability of ADVATE, antihemophilic factor (recombinant) plasma/albumin-free method, during simulated continuous infusion

Blood Coagulation and Fibrinolysis

Volumn 17, Issue 3, 2006, Pages 165-171

  Fernandez, Maximilian ^a   Yu, Tabitha ^a   Bjornson, Erik ^a   Luu, Huong ^a   Spotts, Gerald ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

ADVATE; Continuous infusion; Infusion pumps; Recombinant factor VIII; Stability; Surgery

Indexed keywords

ALBUMIN; GLUCOSE; HEPARIN; POLYETHYLENE; POLYVINYLCHLORIDE; RECOMBINANT BLOOD CLOTTING FACTOR 8; SODIUM CHLORIDE;

ARTICLE; BLOOD COMPONENT; CONTINUOUS INFUSION; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG STABILITY; HEMOPHILIA; HEMOPHILIA A; HEMOSTASIS; HUMAN; HUMAN CELL; HUMAN TISSUE; PRIORITY JOURNAL; SIMULATION; SYRINGE; ULTRAVIOLET RADIATION;

BLOOD COAGULATION TESTS; DRUG STABILITY; FACTOR VIII; HEMOPHILIA A; HEMOSTASIS; HEPARIN; HUMANS; INFUSION PUMPS; INFUSIONS, INTRAVENOUS; LIGHT; MODELS, BIOLOGICAL; PLASMA; QUALITY CONTROL; RECOMBINANT PROTEINS; SERUM ALBUMIN;

EID: 33645522679     PISSN: 09575235     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.mbc.0000220236.92219.08     Document Type: Article

References (37)

1. Bray GL, Gomperts ED, Courter S, Gruppo R, Gordon EM, Manco-Johnson M, et al. A multicenter study of recombinant factor VIII (recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. The Recombinate Study Group. Blood 1994; 83:2428-2435.
2. White GC, Courter S, Bray GL, Lee M, Gomperts ED. A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia. The Recombinate Previously Treated Patient Study Group. Thromb Haemost 1997; 77:660-667.
3. Courter SG, Bedrosian CL. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 2001; 38:44-51.
4. Lusher JM, Lee CA, Kessler CM, Bedrosian CL. ReFacto Phase 3 Study Group. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A. Haemophilia 2003; 9:38-49.
5. Rothschild C, Scharrer I, Brackmann HH, Stieltjes N, Vicariot M, Torchet MF, et al. European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patients [abstract]. Haemophilia 2002; 8 (Suppl 2):10-14.
6. Schwartz RS, Abildgaard CF, Aledort LM, Arkin S, Bloom AL, Brackmann HH, et al. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. Recombinant Factor VIII Study Group. N Engl J Med 1990; 323:1800-1805.
7. Morfini M, Messori A, Longo G. Factor VIII pharmacokinetics: intermittent infusion versus continuous infusion. Blood Coagul Fibrinolysis 1996; 7 (Suppl 1):S11-S14.
8. Martinowitz U, Schulman S, Gitel S, Horozowski H, Heim M, Varon D. Adjusted dose continuous infusion of factor VIII in patients with haemophilia A. Br J Haematol 1992; 82:729-734.
9. Martinowitz U, Schulman S. Continuous infusion of coagulation products. Int J Pediatr Hematol Oncol 1994; 1:471-478.
10. Schulman S. Continuous infusion. Haemophilia 2003; 9:368-375.
11. Batorova A, Martinowitz U. Continuous infusion of coagulation factors. Haemophilia 2002; 8:170-177.
12. Hathaway WE, Christian MJ, Clarke SL, Hasiba U. Comparison of continuous and intermittent Factor VIII concentrate therapy in hemophilia A. Am J Hematol 1984; 17:85-88.
13. MacMillan CW, Webster WP, Roberts HR, Blythe WB. Continuous intravenous infusion of factor VIII in classic haemophilia. Br J Haematol 1970; 18:659-667.
14. Blatt PM, White GC, MacMillan CW, Roberts HR. Treatment of anti-factor VIII antibodies. Thromb Haemost 1977; 38:514-523.
15. Levin J, Ness PM, Bell WR. Continuous infusion of factor VIII concentrate for therapy of hemophilia A [abstract]. Blood 1981; 58:220a.
16. Bona RD, Weinstein RA, Weisman SJ, Bartolomeo A, Rickles FR. The use of continuous infusion of factor concentrates in the treatment of hemophilia. Am J Hematol 1989; 32:8-13.
17. Weinstein RE, Bona RD, Rickles FR. Continuous infusion of monoclonal antibody-purified factor VIII. Am J Hematol 1991; 36:211-212.
18. Hay CR, Doughty HI, Savidge GF. Continuous infusion of factor VIII for surgery and major bleeding. Blood Coagul Fibrinolysis 1996; 7 (Suppl 1):S15-S19.
19. Campbell PJ, Rickard KA. Continuous and intermittent infusion of coagulation factor concentrates in patients undergoing surgery: a single centre Australian experience. Aust NZ J Med 1998; 28:440-445.
20. Dingli D, Gastineau DA, Gilchrist GS, Nichols WL, Wilke JL. Continuous factor VIII infusion therapy in patients with haemophilia A undergoing surgical procedures with plasma-derived or recombinant factor VIII concentrates. Haemophilia 2002; 8:629-634.
21. Martinowitz U, Gitel S, Varon D. Induction of immune tolerance by continuous F VIII infusion [abstract]. In: Hemophilia 1992 World Congress; 12-17 October 1992; Athens, Greece; 1992. p. 51.
22. Gordon EM, Month S, Goldsmith JC. Immune tolerance induction by continuous infusion of monoclonal antibody-purified (MoAb) factor VIII in children [abstract]. Blood 1993; 82 (Suppl 1):62a.
23. Goldsmith JC, Gordon EM. Treatment of hemophilia B: serendipitous use of continuous infusion coagulation factor IX. Thromb Res 1993; 70:265-267.
24. O'Gorman P, Dimichele DM, Kasper CK, Mannucci PM, Santagostini E, Hay CR. Continuous infusion of porcine factor VIII in patients with haemophilia A and high-responding inhibitors: stability and clinical experience. Haemophilia 2001; 7:537-543.
25. Martinowitz U, Schulman S. Review of pumps for continuous infusion of coagulation factor concentrates: what are the options? Blood Coagul Fibrinolysis 1996; 7 (Suppl 1):S27-S33.
26. DiMichele DM, Lasak ME, Miller CH. In vitro factor VIII recovery during the delivery of ultrapure factor VIII concentrate by continuous infusion. Am J Hematol 1996; 51:99-103.
27. Tarantino MD, Collins PW, Hay CRM, Shapiro AD, Gruppo RA, Berntorp E, et al., and the rAHF-PFM Clinical Study Group. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia 2004; 10:1-10.
28. Ewenstein BM, Collins P, Tarantino MD, Negrier C, Blanchette V, Shapiro AD, et al. Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin-free method. Proceedings of a Special Symposium at the XIXth Congress of the International Society on Thrombosis and Haemostasis, July 12-18, 2003. Birmingham, UK. Semin Hematol 2004; 41 (Suppl 2):1-16; discussion 16-18.
29. FDA. International Conference on Harmonisation. Guidelines for the photostability testing of new drug substances and products [online], 16 May 1997. http://www.fda.gov/cber/gdlns/photostab.pdf
30. Hardisty RM, Macpherson JC. A one-stage factor VIII (antihaemophilic globulin) assay and its use on venous and capillary plasma. Thromb Diath Haemorrh 1962; 7:215-228.
31. Martinowitz U. Stability of factor VIII preparation in continuous infusion. Ann Hematol 1994; 68 (Suppl 3):S69-S71.
32. Schulman S, Varon D, Keller N, Gitel S, Martinowitz U. Monoclonal purified F VIII for continuous infusion: stability, microbiological safety and clinical experience. Thromb Haemost 1994; 72:403-407.
33. Schulman S, Gitel S, Martinowitz U. Stability of factor VIII concentrates after reconstitution. Am J Hematol 1994; 45:217-223.
34. Belgaumi AF, Patrick CC, Deitcher SR. Stability and sterility of a recombinant factor VIII concentrate prepared for continuous infusion administration. Am J Hematol 1999; 62:13-18.
35. Thomas KB, Urbancik W, Turecek PL, Gritsch H, Schreiber J, Weber A, et al. Continuous infusion of FVIII and FIX concentrates: in vitro analysis of clinically relevant parameters. Haemophilia 1999; 5:17-25.
36. Parti R, Ardosa J, Yang L, Mankarious S. In vitro stability of recombinant human factor VIII (recombinate). Haemophilia 2000; 6:513-522.
37. Woloschuk DMM, Thomson P, Benson HAE, Schwetz N, Alfa MJ, Hanna K, Israel SJ. In vitro stability of recombinant factor VIII formulated with sucrose [abstract]. Blood 1999; 94 (Suppl 1):122.