octapharma
For the treatment of VWD

What is von Willebrand Disease (VWD)?

Von Willebrand disease (VWD) is an inherited bleeding disorder. It affects the blood’s ability to clot.1-3

VWD is caused by problems with a special protein (a clotting factor) in the blood called von Willebrand factor (VWF). VWF helps platelets in the blood stick together to form blood clots and stop bleeding. A person with VWD does not have enough VWF in the blood or the protein does not work the way it should. VWF also carries clotting factor eight (FVIII), another protein that helps blood to clot.

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Indications and Usage

wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding. wilate® is not indicated for the treatment of hemophilia A.

Important Safety Information

wilate® is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container.

Hypersensitivity or allergic reactions have been observed upon use of wilate® and may in some cases progress to severe anaphylaxis (including shock) with or without fever.

When using a factor VIII (FVIII)-containing von Willebrand Factor (VWF) product, the treating physician should be aware that continued treatment may cause excessive rise in FVIII activity. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate® to avoid sustained excessive VWF and FVIII activity levels, which may increase the risk of thrombotic events.

Patients with VWD, especially type 3 patients, may potentially develop neutralizing antibodies (inhibitors) to VWF, manifesting as an inadequate clinical response. Since inhibitor antibodies may occur concomitantly with anaphylactic reactions, patients experiencing an anaphylactic reaction should also be evaluated for the presence of inhibitors.

wilate® is made from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, eg, viruses and, theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent or other unknown infectious agents, cannot be completely eliminated. Despite measures to reduce this risk, such products may still potentially transmit disease.

The most common adverse reactions to treatment with wilate® in patients with VWD have been urticaria and dizziness. The most serious adverse reactions to treatment with wilate® in patients with VWD have been hypersensitivity reactions.

Please see full prescribing information.

To report suspected adverse reactions, contact:
Octapharma USA Inc.
866-766-4860 or
FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

References

1.  National Heart Lung and Blood Institute. von Willebrand Disease. Last Update 2010. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_All.html. Accessed Apr 12, 2010.

2. Canadian Hemophilia Society. An Introduction to von Willebrand disease. Last Update 2010. Available at: http://www.hemophilia.ca/en/bleeding-disorders/von-willebrand-disease/an-introduction-to-von-willebrand-disease/. Accessed Apr 9, 2010.

3. Nichols WL, Hultin MB, James AH, et al. von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA). Haemophilia 2008;14:171-232.

Photos are of models and for illustrative purposes only.

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