Treatment on-demand

In a clinical trial, VONVENDI successfully treated bleeding on-demand in adult VWD patients.

Study description

VONVENDI, given with or without additional recombinant factor VIII (rFVIII) was studied in a clinical trial to test how it would work to control bleeding episodes. The clinical trial included 22 treated adult patients with VWD. The first dose of VONVENDI was given with rFVIII; if further doses were necessary, rFVIII was given only when needed.* Investigators rated bleed control according to a scale of “Excellent”= 1, “Good”=2, “Moderate”=3, and “None”=4. Treatment success was defined as an average efficacy rating score of less than 2.5 for all bleeding episodes.

*Your doctor will decide if you may use VONVENDI by itself, or if you also require rFVIII along with VONVENDI, based on your clinical situation.
^†This analysis excluded 4 of a total of 22 patients who were treated with VONVENDI in the adult clinical trial.
^‡In the adult clinical study, a median of 1 infusion of VONVENDI (with or without rFVIII) (range 1-4) treated mild-to-moderate bleeding episodes. People who experienced a major bleed required a median of 2 doses (range 1-3 doses). In 2 cases, as many as 3 doses were needed to control bleeding.

Study safety

125 adverse events were reported, 8 of which were considered related to VONVENDI treatment. Six of these 8 adverse events were mild or moderate tingling or burning at infusion site, unusual taste, increased heart rate, change in heart rhythm, itching, and hot flash. The remaining 2 adverse events of chest discomfort and increased heart rate were considered serious and experienced by 1 patient at the same time.

Treat and control bleeding episodes on-demand

VONVENDI can be used on-demand by adults with VWD to control major and minor bleeds in all locations, such as:

Mouth bleeds

Nosebleeds

Heavy menstrual bleeds

GI bleeds

Joint bleeds