VONVENDI® safety

What you need to know about VONVENDI side effects

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.1

Doctor talking to her VWD patient.

Safety evaluated in five prospective, multicenter trials1

Four studies were conducted in subjects with von Willebrand disease and one was conducted in subjects with hemophilia A. The adverse reactions listed below are from three VWD clinical trials with a total of 80 participants, during which VONVENDI was used for pharmacokinetics assessment, on-demand treatment, and management of bleeding episodes in patients undergoing surgery.1

Side effects (most common to least common)

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

Man with blurry vision icon. Dizziness
Stomach icon. Nausea
Unsettled stomach icon. Vomiting

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

Itching hand icon. Itching
Man with vertigo icon. Vertigo

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

Chest icon. Chest discomfort
Vein icon. Deep vein thrombosis
(blood clots)
Three flushes icon. Hot flush
Irregular heart icon. Hypertension
Irregular heart icon. Increased heart rate
Needle icon. Tingling or burning at infusion site
Shaking man icon. Tremor
Tongue icon. 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.

Safety evaluated in the prophylaxis clinical trial

In the completed prophylaxis clinical study, 22 adult patients aged 18 years and older received prophylactic treatment with VONVENDI. The adverse drug reactions reported in this clinical trial are listed below.1

Side effects (most common to least common)

18.2% of participants (4 out of 22) experienced:

Man with blurry vision icon. Headache

13.6% of participants (3 out of 22) experienced:

Joint stiffness icon. Joint stiffness

9.1% of participants (2 out of 22) experienced:

Increased ALT icon. Increased ALT*
(alanine aminotransferase)

4.5% of participants (1 out of 22) experienced:

Increased AST icon. Increased AST*
(asparate aminotransferase)
Heartbeat wavelength icon. Irregularly fast or
erratic heartbeat
Irregular heartbeat wavelength icon. Extra heartbeats or contradictions
Digestive tract icon. Diarrhea
Purple spots icon. Purple spots and patches on skin
Itching hand icon. Itching
Site irritation icon. Injection site irritation

*Increased liver enzyme level in blood

Real VWD patient, Erica standing next to some flowers and smiling. VONVENDI® can be used for on-demand treatment.
Use on-demand

In adult patients with VWD, VONVENDI is approved to control bleeds as they occur.1

Learn more
Doctor discussing with patient.
Use for surgeries

In adult patients with VWD, VONVENDI is approved to manage bleeds related to procedures.1

Learn more

References

  1. VONVENDI Prescribing Information
  2. 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.