octapharma
For the treatment of VWD

Treatment Options

Treatment will usually depend on the specific type of VWD and its severity. Most cases of VWD are very mild, and you may need treatment only when having surgery or dental work or when treating accidental injuries. Medicines to treat VWD act, mainly in one of two ways:1

1. Increase the release of VWF into the blood

2. Replace VWF and FVIII in the blood

Specific treatments for VWD1,2

Desmopressin: Acts to make your body release more VWF and FVIII into your bloodstream.

  • Treatment can be injected or taken by nasal spray
  • Examples: Desmopressin, 1-desamino-8-D-arginine vasopressin (DDAVP)
  • Desmopressin is used mainly for Type 1 VWD
  • Do NOT use for Type 2B as VWF proteins do not work properly in Type 2B

VWF/FVIII concentrates: This treatment is used to replace the VWF and FVIII proteins that are missing from your blood.

  • Treatment is injected
  • Examples:
    wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human),*
    Humate-P®, Antihemophilic Factor/von Willebrand Factor Complex (Human),
    Alphanate®, Antihemophilic Factor/von Willebrand Factor Complex (Human)††
  • Mainly used for severe VWD and patients with mild to moderate VWD who cannot take or do not respond to desmopressin

Non-specific treatments to help stop bleeding1, 2

Other treatments to help stop bleeding may also be used.

Antifibrinolytics: Stop an enzyme that dissolves clots. Help prevent the breakdown of clots that have formed.

  • Examples: Tranexamic acid, aminocaproic acid
Fibrin glues: Create a fibrin “net” to help hold platelets together in a clot.
  • This medicine is placed directly on the injury
  • Examples:
    Beriplast® P Combi-Set, Fibrin sealant kit; Tisseel®, Fibrin Sealant§
  • It is used in dental extractions and surgery
*wilate® is indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

Humate-P® is a registered trademarks of CSL Behring LLC
††Alphanate® is a registered trademark of Grifols Biologicals Inc.

 

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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. National Heart Lung and Blood Institute. von Willebrand Disease. Last Update 2010. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_All.html. Accessed April 12, 2010.

2. 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 April 9, 2010.

 

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·         Treatment is injected

·         Examples: wilate®*, Humate-P®, Alphanate®

Mainly used for Type 3 VWD, and patients with Type 1 or Type 2 who cannot take or do not respond to desmopressin

Photos are of models and for illustrative purposes only.

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