octapharma
For the treatment of VWD

Efficacy in Acute Bleeds

wilate® is effective for bleeding episodes* in patients with all types of VWD.1
wilate® was tested in four clinical studies:1

  • 1,068 bleeding episodes were treated with wilate® in 45 patients
  • Over half of the patients had type 3 VWD (most severe VWD)
  • Most common bleeding sites were joints, nose bleeds, stomach bleeds, and mouth bleeds
  • All patients: Using the objective criteria, 84% of the bleeding episodes* were successfully treated
  • Pediatric patients: Using the objective criteria, 88% of the bleeding episodes* were successfully treated
  • Most of the bleeds were treated for 1-3 days

Successful treatment of bleeding episodes in patients with VWD**, using objective criteria1

Picture_2

93% of the successfully treated bleeds were in patients with VWD type 3 (n=25)1

**Among 70 VWD patients, 45 patients received wilate® on-demand treatment for 1,068 bleeding episodes, including 11 pediatric patients (5-16 years of age), treated for 234 bleeding episodes.1

* A “bleeding episode” may involve bleeding at multiple sites in this analysis.
†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.
‡Other than gastrointestinal

3_Images_12


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.

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