octapharma
For the treatment of VWD

von Willebrand Disease (VWD) & Bleeding

 When you have an injury that bleeds, the protein in the blood called von Willebrand factor (VWF) acts as a “glue” helping the blood clot and close up the wound. In patients with von Willebrand disease this “glue” is missing or may not work very well.

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VWD & Bleeding Slideshows

Normal Clotting

Step 1 - Normal Clotting

When a blood vessel is damaged, it tightens to slow the flow of blood to the injured area.

Step 2 - Normal Clotting

Platelets are very small cells in the blood. They stick to the inside of the blood vessel and plug holes at the injury site.

Step 3 - Normal Clotting

VWF acts as a glue to hold the platelets in place at the site of injury.

Step 4 - Normal Clotting

The clump of platelets provides a surface where blood clotting can happen. Clotting proteins (like FVIII) in the blood gather on the surface of the platelets to form a clot, similar to a scab.

Abnormal Clotting

Step 1 - Abnormal Clotting

When a blood vessel is damaged, the blood vessels tighten normally.

Step 2 & 3 - Abnormal Clotting

A person with VWD may not have enough VWF in the blood, or it may not work normally. So the VWF cannot act as the glue to hold the platelets in place. The platelets do not form a clump.

Step 4 - Abnormal Clotting

The VWF carries factor FVIII in the blood. FVIII is a protein needed to make a solid clot. When VWF is low, so is FVIII. Without normal levels of FVIII, a solid clot takes a very long time to form.

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

 

Reference

1.Canadian Hemophilia Society. An Introduction to von Willebrand disease. Last Update 2010. Available at: http://www.hemophilia.ca/en/bleeding-disorders/von-willebrand-disease/an-introduction-to-von-willebrand-disease/. Accessed Apr 9, 2010.

Photos are of models and for illustrative purposes only.

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