The Clotting Process

VWD is one of the most common hereditary bleeding disorders. Current data and guidelines suggest VWD affects up to 1% of the general population.1,2 In order to understand VWD and its treatment, it helps to know how blood coagulation works and how Humate-P helps clots form properly.

Here is a general description of the blood clotting process:

  • When your body is injured and there is damage to the blood vessels, a plug, or blood clot, forms to stop the bleeding.3
  • A clot is made up of platelets that circulate in your blood, and fibrin that forms to hold the platelets together.3
  • The process that causes clots to form is called clotting.4

For clotting to work, certain protein factors in your blood must work together. One of these factors is von Willebrand factor (VWF), a protein in the blood that is critical to the clotting process.4

Von Willebrand factor and bleeding

VWF is an important part of stopping bleeding after an injury.5 This is why people with VWD have excessive bleeding.

  • VWF binds with platelets, causing them to stick together where the injury has occured.3
  • VWF also stabilizes and protects another factor that’s necessary for clots, factor VIII (FVIII).4
  • If a person can’t make enough VWF, or if their VWF isn’t working properly, it’s called von Willebrand disease.4

How your body clots normally vs. clotting in VWD3

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.

The most commonly reported adverse reactions in patients receiving Humate-P 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, or 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.

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© CSL Behring 2012. The product information on this site is intended for US residents only. 11-HUM-081

References

  1. Data on File. CSL Behring LLC.
  2. Berntorp E, Archey W, Auerswald G, et al. A systematic overview of the first pasteurized VWF/FVIII medicinal product, Haemate P/Humate-P: history and clinical performance. Eur J Haematol. 2008;80 (Suppl 70):3-3.
  3. Hoffman M, Monroe DM. Coagulation 2006: a modern view of hemostasis. Hematol Clin N Am. 2007;21:1-11.
  4. National Heart, Lung, and Blood Institute. The Diagnosis, Evaluation and Management of von Willebrand Disease. National Institutes of Health; 2007. NIH Publication No. 08-5832.
  5. Centers for Disease Control and Prevention. Report on the Universal Data Collection Program: Special report summarizing data on females with von Willebrand disease. 2003; 4 (No.1).