Treatment of von Willebrand disease (VWD) should be supervised by a physician experienced in the treatment of haemostatic disorders. Posology Dose and frequency of administration must be individualized according to clinical judgement and based on the patient´s weight, type and severity of the bleeding episodes/surgical intervention and based on monitoring of appropriate clinical and laboratory measures.
Dose based on bodyweight may require adjustment in underweight or overweight patients. 02 IU/mL (2%). 4 IU/mL (≥ 40% of normal activity). Depending on the patient’s baseline FVIII:C levels, a single infusion of rVWF will, in a majority of patients, lead to an increase above 40% in endogenous FVIII:C activity within 6 hours and will result in sustaining this level up to 72 hours post infusion.
The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of the bleeding, and both VWF:RCo and FVIII:C levels. If the patient’s baseline plasma FVIII:C level is < 40% or is unknown and in all situations where a rapid correction of haemostasis should be achieved, such as treatment of an acute haemorrhage, severe trauma or emergency surgery, it is necessary to administer a recombinant factor VIII product with the first infusion of VEYVONDI, in order to achieve a haemostatic plasma level of FVIII:C.
However, if an immediate rise in FVIII:C is not necessary, or if the baseline FVIII:C level is sufficient to ensure haemostasis, the physician may decide to omit the co- administration of rFVIII at the first infusion with VEYVONDI.
In case of major bleeding events or major surgeries requiring repeated, frequent infusions, monitoring of FVIII:C levels is recommended, to decide if rFVIII is required for subsequent infusions to avoid excessive rise of FVIII:C. Treatment of bleeding episodes (on-demand treatment) in adults and children Start of treatment The first dose of VEYVONDI should be 40 to 80 IU/kg body weight.
4 IU/mL (40%) should be achieved. Dosing guidelines for treatment of minor and major haemorrhages are provided in Table 1. VEYVONDI should be administered with recombinant factor VIII if the FVIII:C levels are < 40%, or are unknown, to control bleeding.
02 (IU/mL)/(IU/kg). The complete dose of VEYVONDI should be administered followed by rFVIII within 10 minutes. Calculating dose VEYVONDI dose [IU] = dose [IU/kg] x body weight [kg] Subsequent infusions A subsequent dose of 40 IU to 60 IU/kg of VEYVONDI should be infused every 8 to 24 hours as per the dosing ranges in Table 1, or as long as clinically appropriate.
In major bleeding episodes, maintain trough levels of VWF:RCo greater than 50% for as long as deemed necessary. Based on experience from clinical trials, once VWF has been replaced, endogenous FVIII levels will remain normal or near normal as long as VEYVONDI is continued to be administered.
Table 1. g. g. severe or refractory epistaxis, menorrhagia, gastrointestinal bleeding, central nervous system trauma, haemarthrosis, or traumatic haemorrhage) 50 to 80 IU/kg 40 to 60 IU/kg every 8 to 24 hours for approximately 2- 3 days (or as long as deemed clinically necessary) a If rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions.
, intracranial or gastrointestinal haemorrhage). 8 IU/mL for major surgery. For prevention of excessive bleeding in case of elective surgery, within 3 hours prior to initiation of any surgical procedure, the FVIII:C levels should be assessed.
8 IU/mL for major surgery, a dose of VEYVONDI alone should be administered within 1 hour prior to the procedure. If the FVIII:C levels are not at the recommended target levels, rFVIII should be administered in addition to vonicog alfa to raise VWF:RCo and FVIII:C, within 1 hour prior to the procedure.
Please refer to Table 2 for FVIII:C recommended target levels. The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding. Table 2. 80 - 1 IU/mL ∆b VWF:RCo x BW (kg) /IRc a Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma […]