octapharma
For the treatment of VWD

High Standards for Efficacy

Most products used for the treatment of bleeding disorders are rated for their ability to successfully stop bleeding on a very subjective scale. This is a scale in which doctors rate the ability of the product to stop the bleeding, in their opinion, on a 4-point scale as “excellent”, “good”, “moderate”, and “none”.

The efficacy of wilate® in the treatment of bleeding episodes was measured using both the traditional subjective criteria and an additional set of objective criteria. In fact, wilate® is the first VWF/FVIII product to be evaluated by the FDA using both criteria. wilate® successfully stopped bleeding in 84% of patients even using this tougher measurement scale.

wilate® objective efficacy criteria: a high standard for success1

Treatment of a bleeding episode was rated "successful" only if ALL criteria were fulfilled:
  • Rating on subjective scale was “excellent” or “good”
  • Patient did NOT require treatment with another VWF-containing product
  • Patient did NOT require a blood transfusion
  • For bleeding episodes that need more than 1 day of treatment, doses of wilate® on the second day were less than half those on the first day
  • Severe bleeding needed <4 days of wilate® treatment‡
  • Moderate bleeding needed <3 days of wilate® treatment‡
  • Minor bleeding needed <2 days of wilate® treatment‡

‡Other than gastrointestinal

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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. wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) full prescribing information. 2009.

 

Photos are of models and for illustrative purposes only.

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