Use of recombinant factor IX in subjects with haemophilia B undergoing surgery

Haemophilia

Volumn 8, Issue 2, 2002, Pages 91-97

  Ragni, Margaret V ^a,b   Pasi, K John ^b   White, G C ^b   Giangrande, Paul L ^b   Courter, Suzanne G ^b   Tubridy, Karen L ^b   Laurian, Yves ^b   Ludlam, Christopher A ^b   Thomas, Angela ^b   Lusher, Jeanne M ^b   Lee, Christine ^b   Philipp, Claire ^b   Roth, David ^b   Shapiro, Amy ^b   Thompson, Arthur ^b   Vermeylen, Jozef ^b   White, Gilbert ^b   Magill, Missy ^b   Dubois, Dana ^b   Rodriguez, Diurka ^b   McCarthy, Kyle ^b   Rup, Bonita ^b   Kaye, James ^b   more..

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

FIX; Haemophilia B; Haemostasis; Recombinant FIX; Surgery; Surgical bleeding

Indexed keywords

BLOOD CLOTTING FACTOR 9; RECOMBINANT PROTEIN; ANTIFIBRINOLYTIC AGENT; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9 CONCENTRATE; BLOOD CLOTTING INHIBITOR; MORPHINE; RECOMBINANT BLOOD CLOTTING FACTOR 9; TRANEXAMIC ACID;

ADOLESCENT; ADULT; AGED; ARTICLE; BLEEDING; BLOOD; CHILD; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; FEMALE; HEMOPHILIA B; HEMOSTASIS; HUMAN; MALE; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PRESCHOOL CHILD; ALLERGY; AREA UNDER THE CURVE; ASTHMA; BLOOD TRANSFUSION; CLINICAL ARTICLE; CONTROLLED STUDY; CORRELATION ANALYSIS; COUGHING; DISEASE SEVERITY; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; FLUSHING; HEADACHE; HIP ARTHROPLASTY; KNEE ARTHROPLASTY; LIVER TRANSPLANTATION; PERIOPERATIVE PERIOD; PHLEBITIS; POSTOPERATIVE HEMORRHAGE; PREOPERATIVE CARE; PRIORITY JOURNAL; RASH; SNEEZING; THROMBOEMBOLISM; VIRUS TRANSMISSION;

ADOLESCENT; ADULT; AGED; BLOOD LOSS, SURGICAL; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FACTOR IX; FEMALE; HEMOPHILIA B; HEMOSTASIS, SURGICAL; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS;

EID: 0036489649     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2516.2002.00587.x     Document Type: Article

References (25)

1. Furie B, Limentani SA, Rosenfield CG. A practical guide to the evaluation and treatment of hemophilia. Blood 1994; 84: 3-9.
2. Choo KH, Gould KG, Rees OJ, Brownlee GG. Molecular cloning of the gene for human anti-haemophilic factor IX. Nature 1982; 299: 178-80.
3. Kurachi K, Davie EW. Isolation and characterization of a cDNA coding for human factor IX. Proc Natl Acad Sci USA 1982; 79: 6461-4.
4. Kaufman RJ, Wasley LC, Furie BC, Furie B, Shoemaker CB. Expression, purification, and characterization of recombinant gamma-carboxylated factor IX synthesized in Chinese hamster ovary cells. J Biol Chem 1986; 261:9622-8.
5. Bond M, Jankowski M, Patel H et al. Biochemical characterization of recombinant factor IX. Semin Hematol 1998; 35 (Suppl. 2): 11-7.
6. White G, Shapiro A, Ragni M, Garzone P, Goodfellow J, Tubridy K, Courter S. Clinical evaluation of recombinant factor IX. Semin Hematol 1998; 35 (Suppl. 2): 33-8.
7. White GC, Beebe A, Nielsen B. Recombinant factor IX. Thromb Haemost 1997; 78: 261-5. .
8. Shapiro A, Abshire T, Gill J, Kisker T, Pasi J, Boulay A, Courter S. Recombinant factor IX (rFIX) in the treatment of previously-untreated patients (PTPs) with severe or moderately-severe hemophilia B. Thromb Haemost Suppl 1998; 473: 1495 (Abstract).
9. Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy K. Human recombinant factor IX. Safety and efficacy studies in patients with hemophilia B. Blood 2001; 98: 3600-6.
10. Lusher JM. Thrombogenicity associated with factor IX complex concentrates. Semin Hematol 1991; 28 (Suppl. 6): 3-5.
11. Ragni MV, Spero JA, Larson P, Ramsey G, Lewis JH. Immune hemolysis by isohemagglutinins in factor IX concentrates. Transfusion 1987; 27: 292-3.
12. Brettler DB, Alter HJ, Dienstag JL, Forsberg AD, Levine PH. Prevalence of hepatitis C antibody in a cohort of hemophilia patients. Blood 1990; 76: 254-6.
13. Mannucci PM, Gdovin S, Gringeri A et al. Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates treated with organic solvent and detergent to inactivate viruses. Ann Intern Med 1994; 120: 1-7.
14. Ragni MV, Koch WC, Jordan JA. Parvovirus B19 infection in patients with hemophilia. Transfusion 1996; 36: 238-41.
15. Ragni MV, Winkelstein A, Kingsley L, Spero JA, Lewis JH. 1986 update of HIV seroprevalence, seroconversion, AIDS incidence, and immunologic correlates of HIV infection in patients with hemophilia A and B. Blood 1987; 70: 786-90.
16. Grosset AB, McGregor JR, Samlowski WE, Rodgers GM. Immunosuppressive effects of factor IX products: an in vitro study. Haemophilia 1999; 5: 416-25.
17. Morfini M, Lee M, Messori A. The design and analysis of half-life and recovery studies for factor VIII and factor IX. Thromb Haemost 1991; 66: 384-6.
18. Cinotti S, Messori A, Morfini M et al. One-stage, two-stage, and chromogenic factor VIII. C assays: a multi-center study. Thromb Res 1991; 61: 385-93.
19. Teitel JM, Bauer KA, Lau HK, Rosenberg RD. Studies of the prothrombin activation pathway utilizing radioimmunoassays for the F2/F1+2 fragment and thrombin-antithrombin complex. Blood 1982; 59: 1086-97.
20. Kasper CK, Aledort LM, Aronson D et al. A more uniform measurement of factor VIII inhibitors. Thromb Diath Haemorrh 1975; 34: 612.
21. Anonymous. SAS User's Guide, Version 6, 4th edn. Cary NC: SAS Institute, 1990.
22. Yamaoka K, Nakagawa T, Uno T. Application of Akaike's information criterion (AIC) in the evaluation of linear pharmacokinetic equations. J Pharm Pharmacol 1978; 6: 165-75.
23. Longo G, Dinotti S, Filimberti E. Single-dose pharmacokinetics of factor IX evaluated by model-independent methods. Eur J Haematol 1987; 39: 426-33.
24. Chowdary P, Dasani H, Jones JAH, Loran CM, Eldridge A, Hughes S, Collins PW. Recombinant factor IX (BeneFix®) by adjusted continuous infusion: a study of stability, sterility and clinical experience. Haemophilia 2001; 7: 140-5.
25. Warrier I, Ewenstein BM, Koerper MA et al. Factor IX inhibitors and anaphylaxis in hemophilia B. J Ped Hematol Oncol 1997; 19: 23-7.