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Thromb Haemost 1995; 73(05): 779-784
DOI: 10.1055/s-0038-1653868
Original Articles
Clinical Studies
Schattauer GmbH Stuttgart

Variability of In Vivo Recovery of Factor IX after Infusion of Monoclonal Antibody Purified Factor IX Concentrates in Patients with Hemophilia B

Gilbert C White II
1   The Center for Thrombosis and Hemostasis, University of North Carolina Medical School, Chapel Hill, NC, USA
,
Amy D Shapiro
2   Riley Hospital for Children, Indiana University Medical Center, Indianapolis, IN, USA
,
Elizabeth M Kurczynski
3   Scottish Rite Children's Medical Center, Atlanta, GA, USA
,
Hugh C Kim
4   Division of Hematology-Oncology, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA
,
Garrett E Bergman
5   Armour Pharmaceutical Company, Collegeville, PA, USA
,
Mononine® Study Group › Author Affiliations
Further Information

Publication History

Received 05 September 1994

Accepted after resubmission 31 January 1995

Publication Date:
09 July 2018 (online)

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Summary

Monoclonal antibody purified factor IX concentrate, Mononine® (Armour Pharmaceutical Company, Kankakee, Illinois, USA), is a recently developed replacement factor concentrate for the treatment of patients with hemophilia B. The pharmacokinetic properties of monoclonal antibody purified factor IX concentrate (MAb Factor IX concentrate) have been evaluated in only small samples of patients, and little is known about those factors that might influence in vivo recovery of factor IX after infusion in a larger patient population. In vivo recovery of factor IX was therefore evaluated for 80 different indications in 72 patients who received MAb Factor IX concentrate for the management of spontaneous or trauma-induced bleeding, or as prophylaxis with surgery. The average recovery after infusions for presurgical pharmacokinetic analysis (mean ± standard deviation) was 1.28 ± 0.56 U/dl rise per U/kg infused (range 0.41-2.80), and the average recovery after all infusions for treatment was 1.23 ± 0.49 U/dl rise per U/kg infused (range -0.35-2.92). Recovery values for multiple MAb Factor IX doses in a given patient were also variable; the average recovery was 1.22 ± 0.53 U/dl rise per U/kg given, and standard deviations ranged from 0.03 to 1.26. Patient age, weight, and MAb Factor IX concentrate dose minimally but significantly influenced factor IX recovery. There was no significant effect of either race, history of previous thrombotic complications during treatment with other replacement factor concentrates, or bleeding state on recovery. All of the patients treated with this preparation experienced excellent hemostasis, and no thrombotic complications were observed.

 

  • References

  • 1 Thompson AR. Factor IX concentrates for clinical use. Semin Thromb Hemost 1993; 19: 25-36
    Article in Thieme ConnectPubMedGoogle Scholar
  • 2 Zauber NP, Levin J. Factor IX levels in patients with hemophilia B (Christmas disease) following transfusion of concentrates of factor IX or fresh frozen plasma (FFP). Medicine 1977; 56: 213-224
    CrossrefPubMedGoogle Scholar
  • 3 Kim HC, Matts L, Eisele J, Czachur M, Saidi P. Monoclonal antibody- purified factor IX - comparative thrombogenicity to prothrombin complex concentrate. Semin Hematol 1991; 28 suppl (Suppl. 06) 15-19
    PubMedGoogle Scholar
  • 4 Goldsmith JC, Kasper CK. et al. Coagulation factor IX: successful surgical experience with a purified factor IX concentrate. Am J Hematol 1992; 40: 210-215
    CrossrefPubMedGoogle Scholar
  • 5 Tengbom L, Stigendal L, Gustafsson G, Strömberg C, Hultmark P. Treatment with a pure factor IX concentrate in a patient with moderate hemophilia B undergoing bilateral total hip replacement. Transfusion 1993; 33: 936-939
    CrossrefPubMedGoogle Scholar
  • 6 Kim HC, McMillan CW, White II GC, Bergman GE, Saidi P. Clinical experience of a new monoclonal antibody purified factor IX: half-life, recovery, and safety in patients with hemophilia B. Semin Hematol 1990; 27 suppl (Suppl. 02) 304-305
    PubMedGoogle Scholar
  • 7 Kim HC, McMillan CW, White II GC, Bergman GE, Horton MW, Saidi P. Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates. Blood 1992; 79: 568-575
    PubMedGoogle Scholar
  • 8 Djulbegovic B, Kim HC. Compassionate treatment with a monoclonal antibody-purified factor IX concentrate in hemophilia B surgical patients who have experienced thrombotic complications with prothrombin complex concentrates. Blood 1993; 82 suppl (Suppl. 01) 154a
    PubMedGoogle Scholar
  • 9 Hrinda ME, Huang C, Tarr GC, Weeks R, Feldman F, Schreiber AB. Preclinical studies of a monoclonal antibody-purified factor IX, Mononine™. Semin Hematol 1991; 28 suppl (Suppl. 06) 6-14
    PubMedGoogle Scholar
  • 10 Aronstam A, McLellan DS, Wassef M, Mbatha PS. Effect of height and weight on the in vivo recovery of transfused factor VIII C. J Clin Pathol 1982; 35: 289-291
    CrossrefPubMedGoogle Scholar
  • 11 Manno CS, Butler RB, Cohen AR. Low recovery in vivo of highly purified factor VIII in patients with hemophilia. J Pediatr 1992; 121: 814-818
    CrossrefPubMedGoogle Scholar
  • 12 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: 384-386
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Kim HC, White II GC. Long-term safety, tolerance, and recovery of factor IX (human) in patients with hemophilia B. Blood 1993; 82 suppl (Suppl. 01) 154 a
    PubMedGoogle Scholar