octapharma
For the treatment of VWD

Stringent Objective Efficacy Criteria

wilate® efficacy assessed using an additional set of stringent objective criteria

The efficacy of wilate® in the treatment of bleeding episodes was analyzed using both the traditional subjective 4-point hemostatic efficacy scale (excellent, good, moderate, and none) and an additional set of objective criteria. In fact, wilate® is the first VWF/FVIII complex to be evaluated by the FDA using both subjective and objective criteria to determine efficacy.

The treatment of a bleeding episode was classified as a success only if all of the objective criteria were fulfilled.1

wilate® objective efficacy criteria: a high standard for success

Treatment of a bleeding episode was rated "succesful" only if ALL criteria were fulfilled:
  • Last efficacy rating of the bleeding episode was “excellent” or “good”
  • Episode was NOT additionally treated with another VWF-containing product (excluding whole blood)
  • Patient did NOT receive a blood transfusion during the episode
  • Follow-up treatment with a daily dosage of wilate® that was  <50% of the initial dose (for bleeding episodes with more than 1 day of treatment)
  • Treatment duration of <4 days in cases of severe bleeding (other than gastrointestinal)
  • Treatment duration of <3 days in cases of moderate bleeding (other than gastrointestinal)
  • Treatment duration of <2 days in cases of minor bleeding (other than gastrointestinal)

 

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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