Wilate

Pronunciation: WILL-ate
Generic name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Dosage form: injection for infusion
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 22, 2023.

What is Wilate?

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) is an injection that may be used to treat episodes of bleeding associated with von Willebrand disease (VWD) in children and adults. It may be used for:

• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes in adults and children age 6 and older.

Wilate may also be used to treat adults and adolescents aged and older with hemophilia A for:

• Routine prophylaxis to reduce the frequency of bleeding episodes
• On-demand treatment and control of bleeding episodes.

Wilate works by temporarily replacing missing von Willebrand factor (VWF) and coagulation factor VIII (FVIII), in the blood to aid in clotting. VWF promotes platelet aggregation and platelet adhesion on damaged blood vessel walls. It also acts as a carrier protein for the procoagulant protein FVIII, an essential cofactor in the activation of factor X leading to the formation of thrombin and fibrin.

Patients suffering from VWD have a deficiency or abnormality of VWF. This reduction in VWF plasma concentration results in correspondingly low FVIII activity and abnormal platelet function, thereby resulting in excessive bleeding. [9] After administration, WILATE temporarily

When infused into a patient with hemophilia A, Wilate replaces missing FVIII which then binds to VWF in the patient´s circulation. Activated FVIII (FVIIIa) acts as a cofactor for activated factor IX (FIXa), accelerating the conversion of factor X to activated factor X (FXa). FXa converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. By increasing levels of FVIII, Wilate temporarily corrects the factor deficiency, resolving the bleeding tendency.

Hemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of antihemophilic factor VIII and results in profuse bleeding into joints, muscles, or internal organs, either spontaneously or as a result of accidental or surgical trauma.

Wilate was first FDA-approved on December 7, 2009, for von Willebrand’s disease. This approval was expanded to hemophilia A on October 8, 2018.

Warnings

Hypersensitivity reactions, including anaphylaxis, have been reported. Do not use if you have ever had a severe allergic reaction to antihemophilic factors in the past or have a known hypersensitivity reaction to human plasma-derived products, any ingredient in the formulation, or components of the container. Tell your doctor immediately if you develop signs of hypersensitivity including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Stop the administration immediately.

Thromboembolic events (blood clots) may occur. Your healthcare provider will monitor you for these. The risk is higher in patients undergoing multiple treatments with Wilate.

There is a potential of developing neutralizing antibodies to VWF, leading to an inadequate response. The risk is higher in VWD type 3 patients. If the expected VWF activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, contact your healthcare provider.

Wilate is made from human plasma. Although extreme care is taken with screening donors and plasma and in the preparation of the product, there is still a risk of transmitting infectious agents.

Carefully follow all instructions about how to store this medicine. Each brand of antihemophilic and von Willebrand factor complex may have specific storage instructions.

Before using

You should not use Wilate if you have ever had a severe allergic reaction to an antihemophilic factor.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.

Your doctor may want you to receive a hepatitis vaccination before you start using Wilate.

Pregnancy and Breastfeeding

It is not known whether Wilate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether the antihemophilic and von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Wilate administered?

Use Wilate exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

• Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
• Wilate is injected into a vein through an IV line and the recommended infusion rate of 2-4 ml/min. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.
• Always wash your hands before preparing and giving your injection.
• Wilate is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
• After mixing the medicine with a diluent, store it at room temperature and use it within 4 hours. Do not refrigerate or freeze.
• Do not use Wilate if it has changed colors or has particles in it. Call your pharmacist for new medicine.

While using this medicine, you may need frequent blood tests.

Wear a medical alert tag or carry an ID card stating that you have hemophilia A or von Willebrand disease. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

What happens if I miss a dose?

Since Wilate is used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Wilate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the side effects of Wilate?

Wilate may cause hypersensitivity reactions. Get emergency medical help if you have signs of an allergic reaction to Wilate: hives; chest tightness, wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• hot flashes when the injection is given
• sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance
• sudden cough, coughing up blood
• pain, swelling, warmth, or redness in one or both legs
• pale or yellowed skin, dark-colored urine, fever, confusion, or weakness
• bleeding from a wound or where the medicine was injected or
• bleeding that is not controlled.

Common Wilate side effects occurring in 1% or more people with VWD may include:

• hypersensitivity reactions
• urticaria
• dizziness

In people with hemophilia A the most common side effect was fever.

Other side effects include:

• nosebleeds
• rash or itching
• numbness or tingling
• headache, dizziness or
• back pain.

To report suspected adverse reactions, contact Octapharma USA Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Wilate?

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.

Related/similar drugs

tranexamic acid, desmopressin, Vonvendi, Cyklokapron, DDAVP, Hemlibra, Advate, Humate-P, von willebrand factor, Alphanate

Storage

Store for up to 36 months at +2°C to +8°C (36°F to 46°F) in the original containers to protect from light from the date of manufacture.

• Within this period, Wilate may be stored for a period of up to 6 months at room temperature (maximum of +25°C or 77°F). Write the starting date of room temperature storage clearly on the product carton.
• Once stored at room temperature, the product must not be returned to the refrigerator.
• The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earliest. Do not freeze.
• Do not use after the expiration date.
• Reconstitute only directly before injection. Use the solution within 4 hours after reconstitution and discard any remaining solution.

Ingredients

Active: Von Willebrand Factor/Coagulation Factor VIII complex derived from large pools of human plasma collected in U.S. plasma donation centers.

• All plasma donations are tested for viral markers in compliance with the requirements of EU CPMP and FDA guidance. In addition, the limit for the titer of human parvovirus B19 DNA in the manufacturing pool is set not to exceed 104 IU/mL.
• The product is manufactured from cryoprecipitate, which is reconstituted in a buffer and treated with aluminum hydroxide followed by two different chromatography steps, ultra- and diafiltration, and sterile filtration.
• The manufacturing process includes two virus inactivation steps, namely, treatment with an organic solvent/detergent (S/D) mixture, composed of tri-n-butyl phosphate (TNBP) and Octoxynol-9, and a terminal dry heat (TDH) treatment of the lyophilized product in final container [at +100°C (212°F) for 120 minutes at a specified residual moisture level of 0.7-1.6%].
• In addition, the ion-exchange chromatography step utilized during Wilate manufacturing also removes some viruses.

Inactive: Glycine, Sucrose, Sodium chloride, Sodium citrate, Calcium chloride, Water for injection, Polysorbate 80.

Components used in the packaging of Wilate are not made with natural rubber latex.

Manufacturer

Octapharma Pharmazeutika Produktionsges for Octapharma USA, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer