VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to: 1) treat and control bleeding episodes; 2) prevent excessive bleeding during and after surgery

VWD can be caused by either3: Not having enough von Willebrand factor (VWF). Having VWF that isn't working properly

What is von Willebrand factor (VWF)?

VWF is a blood protein that helps your body form blood clots that stop bleeding. Your body needs the right amount of functional VWF and factor VIII (FVIII) in order to form blood clots. VWF works in two ways: Platelet glue and FVIII Support.

What are VWD signs and symptoms?

VWD symptoms include: Excessive bleeding, either from an injury or after surgery or dental work. Nosebleeds that last longer than 10 minutes. Heavy or long menstrual bleeding. Bloody urine or stools. Easy bruising or lumpy bruises

Facts About von Willebrand disease (VWD)

Leslie, a real VWD patient sitting down looking at the horizon.

What is VWD?

VWD was named after Dr. Erik von Willebrand, who discovered the disease in a 5-year-old Finnish girl in 1924.² It is a bleeding disorder that makes it difficult to form blood clots, resulting in more frequent bleeds that last longer than normal.¹

VWD is usually hereditary, meaning it's passed down from a parent to a child. In some rare instances, a child can have the disease without a family history of VWD.¹

What causes VWD?

VWD can be caused by either³:

Not having enough von Willebrand factor (VWF)
Having VWF that isn't working properly

There are 3 types of VWD¹

All 3 types of VWD may cause severe or frequent bleeds or symptoms.⁴

Type 1 — Low levels of VWF
Type 2 — VWF doesn't work the way it should
Type 3 — Very little or no VWF

How is VWD diagnosed

In most cases, diagnosing VWD involves reviewing your personal history of abnormal bleeding or bruising, along with screening and diagnostic tests. These tests show your healthcare provider the amount of clotting proteins (VWF and FVIII) in your blood and if those proteins are functioning properly or not.⁷

A long road to diagnosis

Even though it's the most common inherited bleeding disorder, many people with VWD face a long road to diagnosis. In one survey of women with VWD, there was an average of 16 years (range 0-39) between the first symptoms and diagnosis of a bleeding disorder.⁸ As a result, it is suspected that there are many undiagnosed people living with VWD.⁹ 76% of 42 men with VWD had been diagnosed by age 10, but 50% of 38 women with VWD were not diagnosed until after age 12.¹⁰ An accurate diagnosis is extremely important for women in order to avoid unnecessary and/or invasive treatments, such as hysterectomy.⁵

Real VWD patient Erica sitting around the table with her family and friends.

Is VONVENDI^® [von Willebrand factor (Recombinant)] right for you?

VONVENDI was created specifically to treat bleeding episodes in adults with VWD. When infused into your blood stream, it acts like your body's natural von Willebrand factor (VWF), helping to form clots, and helping your own FVIII to work.⁵¹¹¹

VONVENDI is approved for use in adults with VWD Types 1, 2, and 3.⁶¹² It can also be prescribed to manage bleeds in three different ways:

Prophylactically as part of a regular routine for adults with severe type 3 VWD¹¹¹⁵
On-demand during active bleeds¹¹¹⁵
Perioperatively to prevent excessive bleeding during and after surgery¹¹¹⁵

Discover VONVENDI

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

References

What is von Willebrand disease? Centers for Disease Control and Prevention website. Accessed July 9, 2020. http://www.cdc.gov/ncbddd/vwd/facts.html
Nichols WL, Hultin MB, James AH, et al. Von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA). Haemophilia. 2008;14(2):171-232.
Gill JC, Giancarlo C, Windyga J, et al. Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood. 2015;126(17):2038-2045.
The Lewin Group. Strategic Summit on Von Willebrand Disease. National Hemophilia Foundation. 2015. Accessed July 9, 2020. https://www.hemophilia.org/sites/default/files/article/documents/NHF-Strategic-Summit-Report-on-von-Willebrand-disease_1.pdf
Von Willebrand disease. National Organization for Rare Disorders website. Accessed July 9, 2020. https://rarediseases.org/rare-diseases/von-willebrand-disease/
Von Willebrand disease. Mayo Clinic website. Accessed July 9, 2020. https://www.mayoclinic.org/diseases-conditions/von-willebrand-disease/symptoms-causes/syc-20354978
von Willebrand Disease (VWD) Diagnosis. Centers for Disease Control website. Accessed July 9, 2020. https://www.cdc.gov/ncbddd/vwd/diagnosis.html
Kirtava A, Crudder S, Dilley A, Lally C, Evatt B. Trends in clinical management of women with von Willebrand disease: a survey of 75 women enrolled in haemophilia treatment centres in the United States. Haemophilia. 2004;10(2):158-61.
All about von Willebrand disease...for people with von Willebrand disease and their families. Canadian Hemophilia Society. Accessed July 9, 2020. http://www.hemophilia.ca/files/AllAboutVWDRevisedEng.pdf
Data and Statistics on von Willebrand Disease. CDC website. Accessed July 9, 2020. https://www.cdc.gov/ncbddd/vwd/data.html
VONVENDI Prescribing Information
Baxalta receives FDA Approval for VONVENDI, the first and only recombinant treatment for adults affected by von Willebrand disease. Business Wire. December 8, 2015. Accessed July 9, 2020. https://www.businesswire.com/news/home/20151208006689/en/Baxalta-Receives-FDA-Approval-VONVENDIRecombinant-Treatment

More facts about von willebrand disease (VWD)

The most common inherited bleeding disorder¹