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VONVENDI is a brand name for Von Willebrand Factor, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VONVENDI (von Willebrand factor (Recombinant)) is indicated for: • Treatment and Control of bleeding episodes in adults (age ≥18 years) diagnosed with von Willebrand Disease (VWD). • Perioperative management of bleeding in adults (age ≥18 years) diagnosed with VWD. 1.1 Pediatrics Pediatrics (age <18): No data are…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment with VONVENDI should be supervised by a physician experienced in the treatment of hemostatic disorders. Dosage and frequency must be personalized according to clinical judgment and based on the patient’s weight, type and severity of the bleeding episodes and surgical intervention, and also based on monitoring of appropriate clinical and laboratory measures ( See 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
, ≥40% of normal activity). Depending on the patient’s baseline FVIII:C level, a single infusion of rVWF is expected, in a majority of patients, to lead to an increase in endogenous FVIII:C activity above 40% within 6 hours. , one that does not contain VWF) should be administered with the first infusion of VONVENDI to achieve a hemostatic plasma FVIII:C level.
However, if an immediate rise in FVIII:C is not necessary, or if the baseline FVIII:C level is sufficient to ensure hemostasis, then VONVENDI should be administered without rFVIII. In case of major bleeding events or major surgeries requiring repeated, frequent infusions, monitoring of FVIII:C level is recommended, to decide if rFVIII infusion is needed for subsequent infusions and to avoid an excessive rise in FVIII:C.
Page 5 of 34 Patients should be monitored for the development of neutralizing antibodies (inhibitors) against VWF or FVIII. If the expected VWF:RCo activity (Ristocetin cofactor activity) plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a VWF or FVIII inhibitor is present.
See 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use. Treatment of Bleeding Episodes (On-Demand Treatment) Rapid correction of both VWF:RCo and FVIII:C levels is important in the successful management of acute bleeding episodes.
The first dose of VONVENDI should be 40 to 80 IU/kg body weight. Replacement levels of VWF:RCo > 60 IU/dL (60%) and FVIII:C > 40 IU/dL (40%) should be achieved. Dosing guidelines for treatment of minor and major bleeding are provided in Table 1.
Administer VONVENDI with recombinant FVIII (rFVIII) if the FVIII:C level is <40% or is unknown in all situations where a rapid correction to the hemostatic plasma level of FVIII:C should be achieved (such as treatment of an acute hemorrhage, severe trauma or emergency surgery), in order to control bleeding.
1 Adverse Reaction Overview The most common adverse drug reactions (incidence ≥ 2%) reported in the clinical trials were headache, nausea, vomiting, dizziness, vertigo and pruritus generalised. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Two patients were treated with rVWF in both 070701 and 071001 studies; one patient was treated with rVWF in both 071001 and 071101 studies.
e. during or within 24 hours after infusion) was observed for 28% (53/187) of the overall number of adverse events (AEs). The total of 3 serious AEs reported in 2 patients in the safety population (80 patients) were of moderate severity and all non-serious AEs were of mild or moderate severity.
In the surgery study (071101), one asymptomatic patient with ADAMTS13 at 37% of the normal plasma levels, was diagnosed with deep vein thrombosis which was revealed by imaging conducted as a part of the hospital’s standard of care for high-risk patients, 3 days after total hip replacement surgery, while receiving VONVENDI.
1 b Frequency categories common (≥ 1/100 to < 1/10). c Frequency by patient = total number of patients experiencing the AE divided by total number of patients (N) and multiplied by 100. d Frequency by infusions = total number of adverse events divided by total number of infusions (N) and multiplied by 100.
e The reported events of headache were considered by the investigator to be unrelated to treatment Immunogenicity The immunogenicity of VONVENDI was assessed in clinical trials by monitoring the development of neutralizing antibodies against VWF and FVIII, as well as binding antibodies against VWF, Furin, Chinese hamster ovary (CHO) protein and mouse immunoglobulin G (IgG).
, Monitoring and Laboratory Tests). , ≥40% of normal activity). Depending on the patient’s baseline FVIII:C level, a single infusion of rVWF is expected, in a majority of patients, to lead to an increase in endogenous FVIII:C activity above 40% within 6 hours.
, one that does not contain VWF) should be administered with the first infusion of VONVENDI to achieve a hemostatic plasma FVIII:C level. However, if an immediate rise in FVIII:C is not necessary, or if the baseline FVIII:C level is sufficient to ensure hemostasis, then VONVENDI should be administered without rFVIII.
In case of major bleeding events or major surgeries requiring repeated, frequent infusions, monitoring of FVIII:C level is recommended, to decide if rFVIII infusion is needed for subsequent infusions and to avoid an excessive rise in FVIII:C.
Page 5 of 34 Patients should be monitored for the development of neutralizing antibodies (inhibitors) against VWF or FVIII. If the expected VWF:RCo activity (Ristocetin cofactor activity) plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a VWF or FVIII inhibitor is present.
See 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use. Treatment of Bleeding Episodes (On-Demand Treatment) Rapid correction of both VWF:RCo and FVIII:C levels is important in the successful management of acute bleeding episodes.
The first dose of VONVENDI should be 40 to 80 IU/kg body weight. Replacement levels of VWF:RCo > 60 IU/dL (60%) and FVIII:C > 40 IU/dL (40%) should be achieved. Dosing guidelines for treatment of minor and major bleeding are provided in Table 1.
Administer VONVENDI with recombinant FVIII (rFVIII) if the FVIII:C level is <40% or is unknown in all situations where a rapid correction to the hemostatic plasma level of FVIII:C should be achieved (such as treatment of an acute hemorrhage, severe trauma or emergency surgery), in order to control bleeding.
VONVENDI is contraindicated in patients who have had a serious hypersensitivity reaction to this drug or to any ingredient in the formulation, including any non -medicinal ingredient, mouse or hamster proteins, or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition, and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 (IU/dL)/(IU/kg). Administer the complete dose of VONVENDI followed by rFVIII within 10 minutes. g. g. severe or ref ractory epistaxis, menorrhagia, gastrointestinal bleeding, central nervous system trauma, hemarthrosis, or traumatic hemorrhage) 50 to 80 IU/kg 40 to 60 IU/kg every 8 to 24 hours f or approximately 2-3 days (or as long as deemed clinically necessary) a If rFVIII is administered, see rFVIII product monograph for dosing, reconstitution and administration instructions.
, intracranial or gastrointestinal (GI) hemorrhage). Administer a subsequent dose of 40 to 60 IU/kg of VONVENDI every 8 to 24 hours as per the dosing ranges in Table 1, or as long as clinically necessary. In major bleeding episodes, maintain trough levels of VWF:RCo > 50% as long as deemed clinically necessary.
Page 6 of 34 Treatment in Case of Surgery Assess baseline FVIII:C level prior to initiation of any surgical procedure. The recommended minimum FVIII:C target levels prior to initiating the surgical procedure are 30 IU/dL for minor surgery and 60 IU/dL for major surgery.
To raise endogenous FVIII:C level to the recommended minimum target level (30 IU/dL for minor surgery and 60 IU/dL for major surgery), a dose of 40 to 60 IU/kg VONVENDI may be administered 12 to 24 hours prior to initiating surgery.
FVIII:C level should be assessed within 3 hours prior to initiating the surgical procedure. If the level is at the recommended minimum target level, administer a dose of VONVENDI alone within 1 hour prior to the procedure to maintain adequate levels of VWF :RCo and FVIII:C (Table 2).
If the FVIII:C level is below the recommended minimum target level, administer VONVENDI in addition to rFVIII to raise FVIII:C to target level. Refer to Table 2 for recommended VWF:RCo and FVIII:C target peak plasma levels for the prevention of excessive bleeding during and after surgery.
When possible, incremental recovery (IR) for rVWF should be determined before an elective surgery. 0 IU/dL per IU/kg for rVWF. Table 2 – Recommended VWF:RCo and FVIII:C Target Peak Plasma Levels for the Prevention of Excessive Bleeding During and After Surgery Type of Surgery VWF:RCo Target Peak Plasma Level FVIII:C Target Peak Plasma Levela.
Calculation of rVWF Dose (to be administered within 1 hour prior to surgery) (IU VWF:RCo required) Minor 50 - 60 IU/dL 40 - 50 IU/dL ∆b. VWF:RCo x BW (kg) /IRc. Major 100 IU/dL 80 - 100 IU/dL a. Additional rFVIII may be […]
Neutralizing antibodies against either VWF or FVIII were not observed. Of the patients who received VONVENDI in the clinical studies, one patient who was treated perioperatively and for whom no adverse events or lack of hemostatic efficacy was reported, developed treatment-emergent non-neutralizing binding antibodies against VWF following a transfusion of packed red blood cells.
Binding antibodies against potential impurities such as rFurin, CHO-protein or mouse IgG were not observed after treatment with VONVENDI. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, Page 17 of 34 sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, it may be misleading to compare the incidence of antibodies to VONVENDI in the studies described above with the incidence of antibodies in ot her studies or to other products. 5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of VONVENDI.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions:
Infusion related reaction (may include symptoms such as tachycardia, flushing, dyspnea and blurred vision) Immune System Disorders: Anaphylactic reaction
0 (IU/dL)/(IU/kg). Administer the complete dose of VONVENDI followed by rFVIII within 10 minutes. g. g. severe or ref ractory epistaxis, menorrhagia, gastrointestinal bleeding, central nervous system trauma, hemarthrosis, or traumatic hemorrhage) 50 to 80 IU/kg 40 to 60 IU/kg every 8 to 24 hours f or approximately 2-3 days (or as long as deemed clinically necessary) a If rFVIII is administered, see rFVIII product monograph for dosing, reconstitution and administration instructions.
, intracranial or gastrointestinal (GI) hemorrhage). Administer a subsequent dose of 40 to 60 IU/kg of VONVENDI every 8 to 24 hours as per the dosing ranges in Table 1, or as long as clinically necessary. In major bleeding episodes, maintain trough levels of VWF:RCo > 50% as long as deemed clinically necessary.
Page 6 of 34 Treatment in Case of Surgery Assess baseline FVIII:C level prior to initiation of any surgical procedure. The recommended minimum FVIII:C target levels prior to initiating the surgical procedure are 30 IU/dL for minor surgery and 60 IU/dL for major surgery.
To raise endogenous FVIII:C level to the recommended minimum target level (30 IU/dL for minor surgery and 60 IU/dL for major surgery), a dose of 40 to 60 IU/kg VONVENDI may be administered 12 to 24 hours prior to initiating surgery.
FVIII:C level should be assessed within 3 hours prior to initiating the surgical procedure. If the level is at the recommended minimum target level, administer a dose of VONVENDI alone within 1 hour prior to the procedure to maintain adequate levels of VWF :RCo and FVIII:C (Table 2).
If the FVIII:C level is below the recommended minimum target level, administer VONVENDI in addition to rFVIII to raise FVIII:C to target level. Refer to Table 2 for recommended VWF:RCo and FVIII:C target peak plasma levels for the prevention of excessive bleeding during and after surgery.
When possible, incremental recovery (IR) for rVWF should be determined before an elective surgery. 0 IU/dL per IU/kg for rVWF. Table 2 – Recommended VWF:RCo and FVIII:C Target Peak Plasma Levels for the Prevention of Excessive Bleeding During and After Surgery Type of Surgery VWF:RCo Target Peak Plasma Level FVIII:C Target Peak Plasma Levela.
Calculation of rVWF Dose (to be administered within 1 hour prior to surgery) (IU VWF:RCo required) Minor 50 - 60 IU/dL 40 - 50 IU/dL ∆b. VWF:RCo x BW (kg) /IRc. Major 100 IU/dL 80 - 100 IU/dL a. Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
Dosing calculation should be determined based on the IR and product monograph. b. ∆ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo. c. IR = [Plasma VWF:RCo at 30 minutes post-inf usion (IU/dL) – Plasma VWF:RCo at baseline (IU/dL)] / Dose (IU/kg) After the initiation of the surgical procedure, the VWF:RCo and FVIII:C plasma levels should be […]