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Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
Date:1/13/2010

c reactions.  Symptoms may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing.  Contact your doctor promptly with any of these symptoms. Let your doctor know if you have had any previous allergic reactions to other VWF/Factor VIII or other plasma products.

The most common related Adverse Reactions observed during the wilate® clinical studies include: urticaria and dizziness. As with all VWF/Factor VIII products, there is the potential for inducing antibodies to Factor VIII and VWF (inhibitors), especially in VWD type 3 patients. Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed VWF/Factor VIII therapy.

There is also a risk of thromboembolic events associated with von Willebrand factor/Coagulation Factor FVIII (VWF/FVIII) products: plasma levels of FVIII activity should be monitored to avoid sustained excessive FVIII levels, which may increase the risk of thrombotic events. There is also a theoretical risk of infectious agents transmission as the product is made from human plasma.

About VWD:

VWD is the most common bleeding disorder, which is found in approximately 1% to 2% of the U.S. population, according to the Centers for Disease Control and Prevention.(6) The illness is a result of the body's inability to make functional von Willebrand Factor, the human protein that helps clot blood.

About the Octapharma Group:

Headquartered in Lachen, Switzerland, Octapharma
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1. Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
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