octapharma
For the treatment of VWD

Acute Bleeds

All patients: Proven clinical efficacy in the treatment of acute bleeds*

Clinical efficacy of wilate® in the control of bleeding in patients with VWD was evaluated in four prospective clinical studies1

  • Data were obtained from 70 VWD patients, of which 37 were type 3
  • 1,068 bleeding episodes were treated with wilate® on-demand treatment in 45 patients
  • Using the objective criteria, 84% of the bleeding episodes were rated as being successfully treated
  • The most common bleeding sites were joints, followed by epistaxis, GI tract, gynecologic, and oral1
  • The majority of bleeding episodes were treated for 1-3 days. In patients with GI bleeds, the duration for product use to control bleeding could be much longer (up to 7 days).1

Pediatric patients: Proven clinical efficacy in the treatment of acute bleeds*

As part of the prospective clinical studies, 234 bleeding episodesin 11 pediatric patients (5-16 years of age), of whom 73% were type 3 VWD, were treated with wilate®.

  • Using objective criteria, the overall haemostatic efficacy of wilate® was rated as successful in 88% of acute bleeding episodes.
  • The most common bleeding sites were joints, followed by gynecologic, epistaxis, oral, and GI tract.1

Efficacy in all patients and pediatric patients with VWD analyzed by objective criteria1

efficacyinacutebleeds_chart1good
93% of the successfully treated bleeding episodes occurred in patients with VWD type 3 (n=25)1

*In patients with severe VWD as well as patients with mild to moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
A “bleeding episode” may involve bleeding at multiple sites in this analysis.

 

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

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

Photos are of models and for illustrative purposes only.

Copyright © 2017. Octapharma USA Inc. All Rights Reserved.