Von Willebrand Factor Recombinant (Von WILL-a-brand FAK-tor re-KOM-bin-ant)

Treats and controls bleeding episodes, manages bleeding during or after surgery, and reduces the number of bleeding episodes when used regularly in patients with von Willebrand disease.

Brand Name(s):

Vonvendi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use a new needle and syringe each time you inject your medicine.
• To prepare the medicine using 2 bottles (vials):
  • Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.
  • Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.
  • Add the liquid to the powder by turning it upside down.
  • Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.
  • Check the mixture to make sure it is clear. Do not use the medicine if you can see particles or flakes in the mixture or if the mixture is cloudy.
  • Use a sterile plastic disposable syringe to remove the mixture from the bottle.
  • Give the injection as directed by your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature or in the refrigerator, away from heat, moisture, and direct light. Keep from freezing.
• Use the mixture within 3 hours after it is prepared. Do not store and use later.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a recent heart attack or a history of stroke.
• This medicine may increase your risk for blood clots. Tell your doctor if you have a history of blood clots (including disseminated intravascular coagulation, pulmonary embolism).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood, trouble breathing, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with speech, vision, or walking

If you notice these less serious side effects, talk with your doctor:

• Dizziness, nausea, vomiting
• Joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088