Generic Name/API: von Willebrand factor (recombinant)

Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.

Dosage Forms & Strength & Pack Size:
VONVENDI is available as a lyophilized powder in single-dose vials
containing nominally 650 or 1300 international units VWF:RCo.

• Store at refrigerated temperature 2°C to 8°C (36°F to 46°F) or room temperature not to
exceed 30°C (86°F).
• Do not freeze.
• Store in the original box and protect from extreme exposure to light.
• Do not use beyond the expiration date printed on the VONVENDI vial label or carton.
• Do not use if the solution in the syringe is cloudy or contains flakes or particles after filtration
from the vial into the syringe.
• Use reconstituted product immediately or within 3 hours after reconstitution.
• Discard any unused reconstituted product after 3 hours.


VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to:

treat and control bleeding episodes
prevent excessive bleeding during and after surgery
reduce the number of bleeding episodes when used regularly (prophylaxis) in adults with severe Type 3 von Willebrand disease receiving on-demand therapy

Who should not use VONVENDI?
You should not use VONVENDI if you:

Are allergic to any ingredients in VONVENDI.
Are allergic to mice or hamsters.
Tell your healthcare provider if you are pregnant or breastfeeding because VONVENDI may not be right for you.

How should I use VONVENDI?
Your first dose of VONVENDI for each bleeding episode may be administered with a recombinant factor VIII as instructed by your healthcare provider.

Your healthcare provider will instruct you whether additional doses of VONVENDI with or without recombinant factor VIII are needed.

What should I tell my healthcare provider before I use VONVENDI?
You should tell your healthcare provider if you:

Have or have had any medical problems.
Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
Have any allergies, including allergies to mice or hamsters.
Are breastfeeding. It is not known if VONVENDI passes into your milk and if it can harm your baby.
Are pregnant or planning to become pregnant. It is not known if VONVENDI can harm your unborn baby.
Have been told that you have inhibitors to von Willebrand factor (because VONVENDI may not work for you).
Have been told that you have inhibitors to blood coagulation factor VIII.
What else should I know about VONVENDI and von Willebrand Disease?
Your body can form inhibitors to von Willebrand factor or factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop VONVENDI or factor VIII from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to von Willebrand factor or factor VIII.

What are the possible side effects of VONVENDI?
You can have an allergic reaction to VONVENDI.

Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Side effects that have been reported with VONVENDI include: headache, nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, joint pain, joint injury, increased liver enzyme level in blood, hot flashes, itching, high blood pressure, muscle twitching, unusual taste, blood clots and increased heart rate.

Tell your healthcare provider about any side effects that bother you or do not go away.

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