VONVENDI® Prophylaxis Treatment

What is prophylaxis, or "prophy"?

Prophylaxis treatment is taken routinely to reduce the number of bleeds rather than waiting for a bleed to happen and treating it on demand. VONVENDI was tested in a clinical trial for prophylaxis treatment.¹

VONVENDI prophylaxis reduced the number of bleeds in adults with severe Type 3 VWD¹

Annualized bleed rate (ABR) is a common term/abbreviation used when talking about the average number of bleeds a person with a bleeding disorder experiences in a year.²

Median ABR refers to the middle value in a sorted list of annual bleeds.

Trial Description

Routine prophylaxis with VONVENDI was studied over the course of a year in 10 adults with severe Type 3 VWD who had previously received on-demand treatment (Prior OD). During the study, the majority of patients (9/10) received twice-weekly dosing with VONVENDI.¹ The median ABRs were compared for the 12 months during the study (on-study) against the 12 months prior to the study (historical).¹

MEDIAN ABR IN SEVERE TYPE 3 VWD PATIENTS
WHO HAD PREVIOUSLY RECEIVED ON-DEMAND THERAPY

Historical (on-demand)

On-study (prophylaxis)

All bleeds^b

5.0
(3.0, 159.0)

2.3
(0.0, 157.9)

55%

Median ABR (range)^a

0 1 2 3 4 5 6

Spontaneous bleeds^c

3.5
(3.0, 158.0)

1.0
(0.0, 157.9)

76%

Median ABR (range)^a

0 1 2 3 4 5 6

Joint bleeds^b

2.0
(0.0, 7.0)

0.0
(0.0, 1.9)

100%

Median ABR (range)^a

0 1 2 3 4 5 6

Median ABR (range)^a

Median % change in
ABR^a

^a Based on descriptive statistics, which are used to describe the basic features of the data in a study
^b Treated, untreated, traumatic (due to an injury), or spontaneous (without apparent cause)
^c Treated or untreated

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

Prophylaxis Treatment

What is prophylaxis, or "prophy"?

VONVENDI prophylaxis reduced the number of bleeds in adults with severe Type 3 VWD¹

Trial Description

MEDIAN ABR IN SEVERE TYPE 3 VWD PATIENTS
WHO HAD PREVIOUSLY RECEIVED ON-DEMAND THERAPY

With VONVENDI prophylaxis, you may be able to
protect^‡ against bleeds before they even occur¹

Is prophylaxis right for you?

Prophylaxis Treatment

What is prophylaxis, or "prophy"?

VONVENDI prophylaxis reduced the number of bleeds in adults with severe Type 3 VWD1

Trial Description

MEDIAN ABR IN SEVERE TYPE 3 VWD PATIENTS WHO HAD PREVIOUSLY RECEIVED ON-DEMAND THERAPY

With VONVENDI prophylaxis, you may be able to protect‡ against bleeds before they even occur1

Is prophylaxis right for you?

VONVENDI prophylaxis reduced the number of bleeds in adults with severe Type 3 VWD¹

MEDIAN ABR IN SEVERE TYPE 3 VWD PATIENTS
WHO HAD PREVIOUSLY RECEIVED ON-DEMAND THERAPY

With VONVENDI prophylaxis, you may be able to
protect^‡ against bleeds before they even occur¹