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VWF Densitometric Analysis

Densitometric analysis of various VWF/FVIII concentrates1

  • In a study of FVIII/VWF concentrates, Humate-P® was shown to have the highest HMW-VWF content—this correlates with a high amount of specific activity2
  • Among VWF-containing concentrates, Humate-P® has a VWF multimer pattern most like that of normal human plasma2,3
  • Humate-P® contains 93.6% of the corresponding bands in normal human plasma1

Like normal human plasma, Humate-P® has a high percentage of HMW-VWF multimers—enabling it to correct the hemostatic defect in patients with severe VWD4

Click here to view the densitometric tool.


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. Data on file, 2005, CSL Behring LLC.
  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.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.