1 infusion normalized endogenous factor VIII (FVIII) levels over time1,2,a
infusion of VONVENDI® [von Willebrand factor (Recombinant)] achieved hemostatic levels of factor VIII coagulation activity (FVIII:C) in the pivotal phase 3 clinical studies over time1-3
Hemostatic FVIII levels were observed in patients with all types of von Willebrand disease (VWD) in pharmacokinetic (PK) evaluations performed in a non-bleeding state.2,3
Dosing of VONVENDI, with or without recombinant factor VIII (rFVIII), should be based on patient need as determined by monitoring levels and clinical judgment.
Endogenous FVIII:C levels rose at a mean rate of 7.7% per hour (range 1.0%-17.2%) for the first 6 hours in the clinical trials1,4
- PK analyses were performed post-hoc from pooled data across on-demand and surgery trials (N=40)4
- VONVENDI promoted an increase in von Willebrand factor (VWF) activity levels per Ristocetin cofactor assay (VWF:RCo)1
- Mean (SD) half-life was 19.1 (4.32) hours for PK80 and 22.6 (5.34) hours for PK501
Endogenous FVIII:C levels were sustained over 72 hours post-infusion
Median Level (Range) (%)
Normal FVIII:C Range
Time Post VONVENDI Infusion (hours)
aPK analyses were performed in both the on-demand and surgery trials, in a non-bleeding state. Data shown on the graph corresponds to the on- demand trial (50 IU VWF:RCo/kg; n=16).2,3
On-Demand Dosing in Adult VWD Patients
factor may be dosed independently of rFVIII1,a
For the first dose, administer VONVENDI alone if FVIII:C level is ≥40% or if an immediate rise in FVIII:C is not necessary.1
|Hemorrhagic event||Initial doseb||Subsequent dose|
|Minor (eg, readily managed epistaxis, oral bleeding, menorrhagia)||40 to 50 IU/kg||40 to 50 IU/kg every 8 to 24 hours (as clinically required)|
|Majorc (eg, severe or refractory epistaxis, menorrhagia, gastrointestinal (GI) bleeding, central nervous system (CNS) trauma, hemarthrosis, or traumatic hemorrhage)||50 to 80 IU/kg||40 to 60 IU/kg every 8 to 24 hours for approximately 2 to 3 days (as clinically required)|
Dosing of VONVENDI, with or without rFVIII, should be based on patient need as determined by monitoring levels and clinical judgment
aVONVENDI contains only trace amounts of rFVIII.
bIf rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions.
cA bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (eg, intracranial or gastrointestinal hemorrhage).
Surgical Dosing in Adult VWD Patients
factor may also be dosed independently of rFVIII for perioperative management of bleeding in adult VWD patients during elective surgery1,a
Preoperative dosing of VONVENDI for elective surgeryb
12-24 hours prior to surgery1
- VONVENDI may be administered to allow endogenous FVIII levels to increase
Within 3 hours prior to surgery1
- Assess FVIII:C to ensure minimum target levels are achieved
Administer VONVENDI within 1 hour prior to surgery with or without rFVIII
- Administer VONVENDI alone if FVIII:C is at or greater than minimum target levels
- Administer VONVENDI with rFVIII if FVIII:C is below minimum target levels
- If rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions1
|Type of Surgery||Baseline FVIII:C, VWF:RCo, IRc||
VONVENDI Dose (IU VWF:RCo required)
|VWF:RCo (IU VWF:RCo/ kg BW)||FVIII:C (IU FVIII:C/ kg BW)|
VWF:RCo Target peak
|25 to 30 IU/kg||20 to 25 IU/kg||50% to 60%||40% to 50%|
|Major||50 ± 10 IU/kg||40 to 50 IU/kg||100%||80% to 100%|
aVONVENDI contains only trace amounts of rFVIII.
bPlease see full Prescribing Information for VONVENDI dosing in the emergency setting.
cIR = Incremental Recovery as measured in the subject. If the IR is not available, assume an IR of 2.0% per IU/kg.
dAdditional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels. Dosing guidance should be based on the IR.
postoperative dose may be administered up to every other day (every 12-48 hours)1
The following postoperative dosing guidelines should be kept top of mind for VONVENDI:
- Monitor VWF:RCo and FVIII:C plasma levels starting at 12-24 hours and at least every 24 hours1
- Dose VONVENDI based on patient need. If necessary, the frequency of VONVENDI dosing should range between twice a day and every 48 hours1
|Type of Surgery||VWF:RCo Minimum Target Plasma Level||FVIII:C Minimum Target Plasma Level||Minimum Duration of Treatment||Frequency of Dosing|
|Up to 72 hours post surgery||After 72 hours post surgery||Up to 72 hours post surgery||After 72 hours post surgery|
|Minor||≥ 30%||-||> 30%||-||48 hours||Every 12-24 hrs to every other day|
|Major||> 50%||> 30%||> 50%||> 30%||72 hours|
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