octapharma
For the treatment of VWD

Purity

Plasma contains the VWF and FVIII proteins in very low levels. The wilate® manufacturing process is designed to purify the VWF/FVIII complex. (Click here to learn more about how wilate® is made)

When wilate® is separated by the size of its components it shows just one single peak containing only the VWF/FVIII protein complex.1 There is no evidence of other impurities.

wilate® demonstrates one peak when separate by size of its components1

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Contaminating plasma proteins are removed

A VWD replacement treatment should only contain VWF and FVIII proteins to help your blood clot. Other proteins may lead to side effects, or weaken the clotting ability of the VWF concentrate.
Because contaminating proteins are reduced during wilate® production,2 there is no need to add albumin as a stabilizer.

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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. 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.

2. Data on file, Octapharma USA, Inc, 2009.

 

Photos are of models and for illustrative purposes only.

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