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About von Willebrand Disease: What is VWD?

Von Willebrand disease (VWD) is the most common inherited bleeding disorder in humans.1 About one in every 100 people has VWD.2 Unlike hemophilia, which is a bleeding disorder mostly affecting men, VWD affects men and women equally.1

People who have VWD take longer than normal to stop bleeding.1 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.1

Most people who have von Willebrand disease do not even know it.3 They might have key symptoms, but might mistakenly think those signs of VWD are normal or untreatable.


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. National Heart, Lung, and Blood Institute Diseases and Conditions Index. Who gets von Willebrand disease? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_ WhoIsAtRisk.html. Accessed April 29, 2005.
  2. Rodeghiero F, Castamon G, Din F. Epidemiological investigation of the prevalence of von Willebrand disease. Blood. 1987;69:454-459.
  3. Rick ME. Diagnosis and management of von Willebrand's syndrome. Med Clin North Am. 1994;78:609-623.
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