octapharma
For the treatment of VWD

Diagnosing von Willebrand Disease (VWD)

Diagnosing von Willebrand disease (VWD) can be difficult. VWD is relatively rare, and many doctors may not be familiar with it. Your doctor may refer you to a blood disease specialist, called a hematologist.

To diagnose VWD, your doctor will first review your personal and family history of bleeding. If these suggest VWD, specific blood tests can be used to help make the diagnosis. However, the results of blood tests can vary from day to day, and testing may need to be repeated.

Blood tests that may be used to diagnose or screen for VWD1,2

Test What it measures
Bleeding time or PFA 100
(Platelet Function Analyzer)
How long it takes for bleeding to stop
(Many patients with VWD may have normal results)
Factor VIII clotting activity How well FVIII works to stop bleeding
VWF antigen The amount of VWF
VWF ristocetin (ris-to-SEE-tin) cofactor activity
How well VWF works to stop bleeding
VWF multimers Measures the different parts of the VWF protein and
helps determine the type of VWD
Platelet function tests How well platelets work

 

 


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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. 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 April 9, 2010.
2. 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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