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High-Quantity von Willebrand factor (VWF)

The mainstay of von Willebrand disease (VWD) treatment is the replacement of the deficient protein [VWF]1

Quantity: High ratio of VWF:RCo to factor VIII (FVIII)

  • Humate-P® contains larger amounts of VWF than it does FVIII1
    — The average ratio of VWF:RCo to FVIII activity is 2.4 to 12

International unit (IU) activity of VWF:RCo and FVIII per vial of Humate-P®1

VWF:RCo/vial FVIII/vial Ratio Diluent
600 IU 250 IU 2.4 to 1 5 mL
1200 IU 500 IU 2.4 to 1 10 mL
2400 IU 1000 IU 2.4 to 1 15 mL

  • Because VWF:RCo is the most accepted and specific method for determining VWF activity,3 VWF:RCo units are used to calculate the amount of VWF necessary for dosing
  • High ratio of VWF:RCo to FVIII can allow adjustment of VWF levels without raising FVIII levels to unacceptable levels4

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is indicated in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia). Humate-P® is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.

Humate-P® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations or to any of its components.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures considered.

Humate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Although few adverse reactions have been reported the most common are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.

Please see accompanying full prescribing information for Humate-P®.

The information provided herein is solely for use by physicians and healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.

References

  1. Mannucci PM. Treatment of von Willebrand’s disease. N Engl J Med. 2004;351:683-694.
  2. Data on file, 2005, CSL Behring LLC.
  3. Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, Haemate-P/Humate-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost. 2002;87:224-230.
  4. Kraaijenhagen RA, in't Anker PS, Koopman MMW, et al. High plasma concentration of factor VIIIc is a major risk factor for venous thromboembolism. Thromb Haemost. 2000;83:5-9.