octapharma
For the treatment of VWD

wilateBridgeTitle
 

Prescribing Information

The Octapharma wilate Free Trial is a unique opportunity for von Willebrand Disease (VWD) patients and their providers to experience the safety, efficacy and convenience of wilate® von Willebrand Factor/Coagulation Factor VIII Complex (Human) at no cost.

If you have a VWD patient currently using another VWF/FVIII product, or a patient not currently using factor treatment, you may want to consider wilate®. With the Octapharma wilate Free Trial, eligible VWD patients can receive treatment with wilate® (not to exceed 6 doses or not exceed approximately 20,000 IUs) at no cost, shipped directly to the patient and administered under the supervision and care of their physician.

There’s never been a better time to try wilate® and see first hand if wilate® is right for your patients with VWD.

How it works…

  • Physician identifies a patient for the Octapharma wilate® Free Trial
  • Physician initiates Enrollment and Patient Consent Forms and writes a prescription for wilate®
  • Physician supplies the Enrollment and Patient Consent Forms and prescription to patient
  • Patient completes both Forms, signs and faxes all documents to Program Administrator (Covance at 1-800-554-6744)
  • Program Administrator reviews documents to ensure patient meets program criteria
  • Program Administrator processes completed Enrollment and Patient Consent Forms and prescription to pharmacy for dispensing of wilate®
  • Program Administrator confirms wilate® is shipped to patient
  • Patient is administered wilate® under the supervision and care of a physician

 

 

 

 

 

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

Photos are of models and for illustrative purposes only.

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