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Humate-P® for von Willebrand Disease—High-Quality VWF

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

Quality: high molecular weight von Willebrand factor (HMW-VWF) multimers2

  • HMW-VWF demonstrates increased hemostatic activity2
  • HMW-VWF is associated with
    — High specific activity2
    — VWF:ristocetin cofactor (VWF:RCo) activity
    — Collagen-binding activity
  • High molecular weight von Willebrand factor is also associated with shortened bleeding time3

Like normal human plasma, Humate-P® contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers2, and it is capable of correcting the hemostatic defect in patients with severe VWD.4

In fact, in an analysis of FVIII/VWF concentrates3,4, Humate-P® has been shown to have the highest HMW-VWF content. Click here to see an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.


Important Safety Information


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 known risk factors for thrombosis.

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

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

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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. 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.
  3. Berntorp E, Nilsson IM. Use of a high-purity factor VIII concentrate (Hemate P) in von Willebrand's disease. Vox Sang. 1989;56:212-217.
  4. Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol. 1988;40:205-214.
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