Wilate

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) is an injectable medicine used to treat and prevent bleeding in children and adults with von Willebrand disease (VWD) and in adolescents 12 years of age and older and adults with hemophilia A.

In von Willebrand disease, Wilate 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 hemophilia A, Wilate may be used for:

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

Wilate was first FDA-approved on December 7, 2009, for von Willebrand disease. This approval was expanded to include hemophilia A on October 8, 2018. There is no Wilate generic.

Hypersensitivity reactions, including anaphylaxis, have been reported with Wilate. Do not use Wilate 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.

Neutralizing antibodies (inhibitors) to VWF and factor VIII have occurred following administration of Wilate, which can lead to an inadequate response. If the expected VWF or factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an adequate dose or repeated dosing, contact your healthcare provider, as this may indicate the development of an inhibitor.

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.

Do not use Wilate if you are allergic to von Willebrand Factor or Factor VIII or any of the other ingredients of Wilate.

Before receiving Wilate, tell your healthcare provider about all your medical conditions, including:

• if you have ever had a stroke or a blood clot
• if you are pregnant or planning a pregnancy
• if you are breastfeeding or planning to breastfeed.

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 breastfeeding a baby.

Wilate works by temporarily replacing two proteins needed for normal clotting: von Willebrand factor (VWF) and coagulation factor VIII (FVIII). VWF helps platelets stick together and adhere to damaged blood vessel walls, and it also carries and stabilizes FVIII.

People with von Willebrand disease have too little VWF or VWF that does not work properly, which lowers FVIII activity and impairs platelet function, leading to excessive bleeding. In hemophilia A, an inherited disorder caused by low levels of factor VIII, bleeding can occur in the joints, muscles, or internal organs, either spontaneously or after injury or surgery. By raising VWF and FVIII levels, Wilate temporarily corrects the deficiency and helps control the bleeding tendency.

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
• bleeding that is not controlled.

Common side effects

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

• hypersensitivity reactions
• urticaria
• chest discomfort
• 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
• 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.

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 at the recommended infusion rate of 2 to 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 color 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.

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.

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 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.

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

Inactive: glycine, sucrose, sodium chloride, sodium citrate, calcium chloride, water for injection, and polysorbate 80.

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

Wilate is manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria (U.S. License No. 1646) and distributed by Octapharma USA, Inc., Paramus, NJ 07652.