Safety evaluated in four prospective, multicenter trials¹

Three studies were conducted in subjects with von Willebrand disease (VWD) and one was conducted in subjects with hemophilia A. The adverse reactions reported in the three VWD trials, with a total of 80 participants, are listed below.¹

Side effects (most common to least common)

3.75% of participants (3 out of 80) experienced:

Dizziness

Nausea

Vomiting

2.5% of participants (2 out of 80) experienced:

Itching

Vertigo

1.25% of participants (1 out of 80) experienced:

Chest discomfort

Deep vein thrombosis
(blood clots)

Hot flush

Hypertension

Increased heart rate

Tingling or burning at infusion site

Tremor

Unusual taste

Of the 125 total adverse events observed during the study, 8 (6.4%) were considered to have a causal relationship to VONVENDI.²

These are not all the possible side effects with VONVENDI. You can ask your healthcare provider for information that is written for healthcare professionals. Tell your healthcare provider about any side effects that bother you or do not go away.

See Detailed Important Risk Information

What is VONVENDI?

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

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

VONVENDI^® [von Willebrand factor (recombinant)] Important Information

What is VONVENDI?

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

Detailed Important Risk Information

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: nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see VONVENDI full Prescribing Information

VONVENDI^® safety

What you need to know about VONVENDI side effects

Safety evaluated in four prospective, multicenter trials¹

References

VONVENDI® safety

What you need to know about VONVENDI side effects

Safety evaluated in four prospective, multicenter trials1

References

VONVENDI^® safety

Safety evaluated in four prospective, multicenter trials¹