octapharma
For the treatment of VWD

Symptoms

von Willebrand disease (VWD) is caused by a deficiency or dysfunction in von Willebrand factor (VWF) – a plasma protein that assists platelets in clustering and adhering to the blood vessel wall and one that is vital for normal blood clotting. The most common presenting symptom in patients with VWD is bleeding, usually involving mucous membranes and skin sites. Bleeding is usually of mild to moderate severity, reflecting the predominance of type 1 VWD. However, life-threatening bleeding (CNS, gastrointestinal) can occur in patients with type 3 VWD, those with type 2 VWD, and even (rarely) in those with type 1 VWD.2

Other symptoms suggestive of VWD include:2

  • Easy bruising
  • Prolonged bleeding from minor cuts
  • Heavy or prolonged menstrual bleeding
  • Bleeding in the upper and lower gastrointestinal tract
  • Prolonged bleeding following injury, surgery, dental work, or childbirth

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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. Castaman G, Federici AB, Rodeghiero F, Mannucci PM. von Willebrand’s disease in the year 2003: towards the complete identification of gene defects for correct diagnosis and treatment. Haematologica. 2003;88:94–108.

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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