In vitro and in vivo stability of diluted recombinant factor VIII for continuous infusion use in haemophilia A

Haemophilia

Volumn 16, Issue 1, 2010, Pages 72-79

  Revel Vilk, S ^a   Blanchette, V S ^b   Schmugge, M ^a   Clark, D S ^a   Lillicrap, D ^c   Rand, M L ^b  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c QUEEN S UNIVERSITY   (Canada)

Author keywords

Continuous infusion; Dilution; In vitro; In vivo; Kogenate FS; Stability

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8; SODIUM CHLORIDE;

ARTICLE; CONTINUOUS INFUSION; DILUTION; DRUG STABILITY; DRUG STORAGE; ELECTIVE SURGERY; HEMOPHILIA A; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INFUSION PUMP; POSTOPERATIVE CARE; PRIORITY JOURNAL; VASCULAR ACCESS;

CHILD, PRESCHOOL; DRUG STABILITY; FACTOR VIII; HEMOPHILIA A; HUMANS; INFUSION PUMPS; INFUSIONS, INTRAVENOUS; MALE; POSTOPERATIVE HEMORRHAGE;

EID: 73949151181     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2009.02103.x     Document Type: Article

References (27)

1. Schulman S. Continuous infusion. Haemophilia 2003, 9:368-75.
2. Batorova A, Martinowitz U. Continuous infusion of coagulation factors: current opinion. Curr Opin Hematol 2006, 13:308-15.
3. Hathaway WE, Christian MJ, Clarke SL, Hasiba U. Comparison of continuous and intermittent Factor VIII concentrate therapy in hemophilia A. Am J Hematol 1984, 17:85-8.
4. Weinstein RE, Bona RD, Rickles FR. Continuous infusion of monoclonal antibody-purified factor VIII. Am J Hematol 1991, 36:211-2.
5. Batorova A, Martinowitz U. Intermittent injections vs. continuous infusion of factor VIII in haemophilia patients undergoing major surgery. Br J Haematol 2000, 110:715-20.
6. Martinowitz U, Schulman S, Gitel S, Horoszowski H, Heim M, Varon D. Adjusted dose continuous infusion of factor VIII in patients with haemophilia A. Br J Haematol 1992, 82:729-34.
7. Bidlingmaier C, Deml MM, Kurnik K. Continuous infusion of factor concentrates in children with haemophilia A in comparison with bolus injections. Haemophilia 2006, 12:212-7.
8. Négrier C, Shapiro A, Berntorp E. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of Advate in previously treated patients. Thromb Haemost 2008, 100:217-33.
9. Martinowitz U, Luboshitz J, Bashari D. Stability, efficacy, and safety of continuously infused sucrose-formulated recombinant factor VIII (rFVIII-FS) during surgery in patients with severe haemophilia. Haemophilia 2009, 15:676-85.
10. Henze W, Kellermann E, Larson P, Gorina E. Stability of full-length recombinant FVIII formulated with sucrose during continuous infusion using a mini-pump infusion device. J Thromb Haemost 2005, 3:1530-1.
11. Woloschuk DM, Thomson P, Benson HA, Schwetz N, Hanna K, Israels SJ. In-vitro stability of recombinant factor VIII formulated with sucrose. Blood 1999, 94:Abstract 122b.
12. Woloschuk DM, Benson HA, Schwetz N, Hanna K, Israels SJ. In-vitro stability of recombinant FVIII (Kogenate-FS) stored in an ambulatory micro-infuser device. Blood 2000, 96:Abstract 79b.
13. 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, 72:403-7.
14. Schulman S, Gitel S, Martinowitz U. Stability of factor VIII concentrates after reconstitution. Am J Hematol 1994, 45:217-23.
15. 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.
16. Woloschuk DMM, Rubinger M, Israels SJ, Houston D, Schwetz N, Johnston JB. In-vitro stability of porcine factor VIII (Hyate:C®). Haemophilia 1997, 3:21-3.
17. Wakabayashi H, Schmidt KM, Fay PJ. Ca(2+) binding to both the heavy and light chains of factor VIII is required for cofactor activity. Biochemistry 2002, 41:8485-92.
18. Walker SE, Gray S, Schmidt B. Stability of reconstituted indomethacin sodium trihydrate in original vials and polypropylene syringes. Am J Health Syst Pharm 1998, 55:154-8.
19. Fernandez M, Yu T, Bjornson E, Luu H, Spotts G. Stability of ADVATE, Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method, during simulated continuous infusion. Blood Coagul Fibrinolysis 2006, 17:165-71.
20. Neidhardt E, Koval R, Burke E, Warne N. In vitro evaluation of B-domain deleted recombinant factor VIII (ReFacto) stability during simulated continuous infusion administration. Haemophilia 2005, 11:319-25.
21. Parti R, Ardosa J, Yang L, Mankarious S. In vitro stability of recombinant human factor VIII (Recombinate). Haemophilia 2000, 6:513-22.
22. McLeod AG, Walker IR, Zheng S, Hayward CP. Loss of factor VIII activity during storage in PVC containers due to adsorption. Haemophilia 2000, 6:89-92.
23. Barrowcliffe TW. FVIII and FIX Subcommittee. Recommendations for the assay of high-purity Factor VIII concentrates. Thromb Haemost 1993, 70:876-7.
24. Lusher JM, Hillman-Wiseman C, Hurst D. In vivo recovery with products of very high purity - assay discrepancies. Haemophilia 1998, 4:641-5.
25. Mikaelsson M, Oswaldsson U. Assaying the circulating factor VIII activity in hemophilia A patients treated with recombinant factor VIII products. Sem Thromb Hemost 2002, 28:256-64.
26. Lollar P. The factor VIII assay problem: neither rhyme nor reason. J Thromb Haemost 2003, 1:2275-9.
27. Hubbard AR, Weller LJ, Bevan SA. Activation Profiles of FVIII in concentrates reflect one-stage/chromogenic potency discrepancies. Br J Haematol 2002, 117:957-60.