octapharma
For the treatment of VWD

Removal of Impurities

Accompanying plasma proteins are efficiently removed

wilate® exhibits high purity. The purification level of clotting factors is defined as specific activity, or the amount of the desired clotting factor per mg of total protein.1 High purity has been defined as a specific activity of 1-100 units/mg protein for Factor VIII (FVIII).2 The specific activity for wilate® is  >60 IU/mg VWF:RCo and  >60 IU/mg FVIII activities per mg of total protein. Actual mean specific activity for both VWF:RCo and FVIII averaged >100 IU/mg total protein for each, suggesting a high purity concentrate.3 No albumin is added as a stabilizer.4

wilate® demonstrates high specific activity and a physiologic 1:1 ratio of VWF and FVIII5

  wilate® Humate-P®
Specific activity of
final product*
>60 1-2
Ratio of VWF:FVIII 1:1 1.8-2.8:1

*IU VWF/mg total protein after addition of stabilizer The clinical relevance of this data has not been established.

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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.
  2.  Stadler M, Gruber G, Kannicht C, et al. Characterisation of a novel high-purity, double virus inactivated von Willebrand factor and factor VIII concentrate (Wilate®). Biologicals. 2006;34:1-8.
  3. Farrugia A. Guide for the assessment of clotting factor concentrates for the treatment of hemophilia. World Federation of Hemophilia. Available at: http://www.wfh.org/2/docs/Publications/Safety_and_Supply/ GuideClottingFactor_Eng.pdf. Accessed January 29, 2010.
  4. DiMichele DM, Kroner BL, and The North American Immune Tolerance Study Group. The North American Immune Tolerance Registry: practices, outcomes, outcome predictors. Thromb Haemost. 2002;87:52-57.
  5. Data on file. Octapharma USA Inc. 2011.

 

 

Photos are of models and for illustrative purposes only.

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