octapharma
For the treatment of VWD

Diagnosing von Willebrand Disease (VWD)

To diagnose von Willebrand disease (VWD), initial clinical assessment should focus on a personal history of excessive bleeding and family history of bleeding disorders to determine whether the patient may benefit from further diagnostic evaluation.1

Initial evaluation of patients for bleeding disorders1

1. Have you or a blood relative ever needed medical attention for a bleeding problem or been told you have a bleeding disorder or problem:
  • During/after surgery?
  • With dental procedures, extractions?
  • With trauma?
  • During childbirth or for heavy menses?
  • Ever had bruises with lumps?
2. Do you have or have you ever had:
  • Liver or kidney disease; a blood or bone marrow disorder; a high or low platelet count?
3. Do you take aspirin, NSAIDs, clopidogrel, warfarin, heparin?

 

Initial evaluation of patients to determine whether laboratory testing is indicated. The initial strategy is to determine which patients would benefit most from further diagnostic evaluation for von Willebrand disease (VWD) or other bleeding disorders. Individuals (for example, an asymptomatic person who will undergo a surgical or other invasive procedure) would be asked three questions about their personal and family bleeding history, which, if any responses are positive, would lead to a second set of questions selected for sensitivity and specificity for VWD. Click here {yootooltip title=[http://www.nhlbi.nih.gov] display=[inline]} Clicking this link will open a new browser window, accessing a third party website maintained by a third party over whom Octapharma has no control. Octapharma is not responsible for, and accepts no responsibility for, information contained in a third party website. To return to the wilate® USA website, close the new window. {/yootooltip} to view the NHLBI guidelines for intital evaluation of VWD.
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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. Nichols WL, Hultin MB, James AH, et al. von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA). Haemophilia. 2008;14:171-232.

Photos are of models and for illustrative purposes only.

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