VWF Densitometric Analysis

View an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.

VWF Densitometric Analysis

In a densitometric analysis of various FVIII/VWF concentrates, Humate-P has been shown to have the highest content of HMW-VWF multimers, represented in the graph by the blue line. The multimer pattern of Humate-P is most like that of normal human plasma,1 which is represented by the black line. In contrast, the multimer patterns of products A, G, H, and E, represented in the densitometric analysis by the red, green, orange, and yellow lines, respectively, differ markedly from that of normal human plasma. Specifically, Humate-P contains 94% of the corresponding bands in normal human plasma.2

The densitometric analysis shows that, like normal human plasma, Humate-P contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers1, and it is capable of correcting the hemostatic defect in patients with VWD.

Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is indicated for treatment and prevention of bleeding in adult patients with 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 not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with risk factors for thrombosis.

Humate-P is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions (reported by >5% of subjects) were allergic/anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis.

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The information provided here is primarily intended for use by physicians and other 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.

Treatment for VWD patients

© CSL Behring 2018. The product information presented on this site is intended for US residents only. 11-HUM-082

References

  1. Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Müller H-G, Friedbold J. Characterization of factor VIII/von Willebrand factor concentrates using a modified method of von Willebrand factor multimer analysis. Hemophilia. 1998;4(suppl 3):25-32.
  2. Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol. 1988;40:205-214.