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About von Willebrand Disease

Von Willebrand Disease (VWD) affects both men and women and is one of the most common hereditary bleeding disorders.1,2 Current data and guidelines suggest VWD affects up to 1% of the general population. 1,2

People who have VWD take longer than normal to stop bleeding.3 Why? A protein in the blood, called von Willebrand factor (VWF), helps clots form. People with von Willebrand disease don’t have enough von Willebrand factor or their VWF might not work properly.3

Most people who have von Willebrand disease do not even know it.4 They might have key symptoms, but might mistakenly think those signs of VWD are normal or untreatable.

www.AllAboutBleeding-us.com provides valuable information and resources for people with VWD and their caregivers.


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

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.

References

  1. Centers for Disease Control and Prevention. Report on the Universal Data Collection Program: Special report summarizing data on females with von Willebrand disease. December 2003;5(1).
  2. National Heart, Lung, and Blood Institute. The diagnosis, evaluation and management of von Willebrand Disease. 2007. NIH Publication No. 08-5832. Available at www.nhlbi.nih.gov/guidelines/vwd/. Accessed June 16, 2010.
  3. National Hemophilia Foundation. What is von Willebrand disease? Available: http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=182&contentid=47&rptname=bleeding. Accessed July 20, 2010.
  4. Rick ME. Diagnosis and management of von Willebrand's syndrome. Med Clin North Am. 1994;78:609-623.