Anaphylaxis after treatment with recombinant factor VIII.

Abstract

BACKGROUND:

Treatment of hemophilia patients with recombinant factor VIII concentrates has not previously been associated with anaphylaxis.

STUDY DESIGN AND METHODS:

A 5-week-old boy with severe hemophilia A developed dyspnea, cyanosis, hypotension, and a diffuse urticarial rash following treatment with a recombinant factor VIII (Recombinate). To identify the cause of anaphylaxis in this patient, the vial lot was examined for the presence of endotoxin, and a checkerboard immunoblotting technique was used to test serum and/or plasma samples from the patient and mother for the presence of antibodies (IgA, IgG, IgE, and IgM) to Recombinate-related antigens (recombinant factor VIII, von Willebrand factor, human serum albumin, Chinese hamster ovary proteins, bovine serum albumin, mouse monoclonal anti-human factor VIII, polyethylene glycol 3350), and to ethylene oxide, the agent used to sterilize the infusion equipment.

RESULTS:

No immune response directed against the Recombinate-related antigens or ethylene oxide that could be associated with the anaphylactic reaction was identified. Endotoxin was not present upon rabbit pyrogen testing of the therapeutic product.

CONCLUSION:

These studies failed to show any association between Recombinate and the onset of the allergic reaction. This seems to be the first reported case of anaphylaxis following the infusion of a recombinant form of factor VIII concentrate.

• Authors: R I Shopnick, M Kazemi, D B Brettler, C Buckwalter, L Yang, G Bray, E D Gomperts
• Journal: Transfusion (Transfusion) Vol. 36 Issue 4 Pg. 358-61 (Apr 1996) ISSN: 0041-1132 [Print] United States
• PMID: 8623140 (Publication Type: Case Reports, Journal Article)

Chemical References

• Antigens
• Recombinant Proteins
• F8 protein, human
• Factor VIII

Topics

• Anaphylaxis (etiology, immunology)
• Antigens (immunology)
• Factor VIII (adverse effects, immunology, therapeutic use)
• Hemophilia A (therapy)
• Humans
• Infant
• Male
• Recombinant Proteins (adverse effects, immunology, therapeutic use)