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VONVENDI® [von Willebrand factor (Recombinant)] On Demand

Trial design

VONVENDI, given with and without additional recombinant FVIII (rFVIII), was studied in 22 adult patients with different types of severe von Willebrand disease (VWD) to test how it would work to control a total of 192 bleeds. The first dose of VONVENDI was given with rFVIII; if further doses were necessary, rFVIII was given only when needed. Investigators rated bleed resolution according to a scale of "Excellent=1," "Good=2," "Moderate=3," or "None=4." Treatment success was defined as a mean efficacy rating score of less than 2.5 for all bleeding episodes.^1,2

100% pie chart depicting that 100% of people had their bleeds successfully treated with VONVENDI®.

100% of people (18/18) had their bleeds successfully treated^1b

97% pie chart depicting that 97% of 192 bleeds were rated as Excellent with VONVENDI®.

97% of 192 bleeds were rated as "Excellent," with the remaining 3% rated as "Good"¹

82% pie chart depicting that 82% of 192 bleeds were cleared up after just one infusion of VONVENDI®.

82% of 192 bleeds were cleared up after just one infusion (ranges 1-4)^1a

^aYour doctor will decide if you may use VONVENDI by itself, or if you also require rFVIII along with VONVENDI, based on your clinical situation.¹

^bThis analysis excluded 4 of a total of 22 patients who were treated with VONVENDI in the trial.¹

In the clinical study, an average of one infusion of VONVENDI (with or without rFVIII) (ranges 1-4) treated mild-to-moderate bleeding episodes. People who experienced a major bleed required an average of two doses (range 1-3 doses). In two cases, as many as three doses were needed to control bleeding.¹

Leslie's story

Diagnosed with VWD in 2003

"Once I was trained on how to do my own infusion, I infused on the eve of the surgery and again right before. I also infused after surgery—this was my normal for any surgery. I was amazed at how well this treatment worked for me."

"I try not to let my blood disorder get me down. As I tell my son, life is what you make of it. My adventure is not done; my story is not finished."

See her story

Erica's story

Diagnosed with VWD in 1981

"I feel fortunate that there's been an increase in awareness when it comes to VWD, from diagnosis and available information to patient care."

"The doctor came back with a diagnosis: VWD type 2B. It was something I had never heard of before… but something that would change my life forever."

See her story

Nicole's story

Diagnosed with VWD in 2009

"Although I've faced many battles since I was diagnosed, the amount of support I had from all the other patients fighting the same battle gave me strength."

"I was experiencing nosebleeds that lasted 15 minutes or more almost every day. My new doctor told me I needed to manage my bleeds, and discussed beginning a treatment called VONVENDI."

See her story

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
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

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
reduce the number of bleeding episodes when used regularly (prophylaxis) in adults with severe Type 3 von Willebrand disease receiving on-demand therapy

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: 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.

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

Treatment on-demand

Trial design

Treat and control bleeding
episodes on-demand