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Veyvondi is a brand name for Vonicog Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prevention and treatment of haemorrhage or surgical bleeding in adults (aged 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. 3 Treatment of haemorrhage in children (aged less than 18 years) with von Willebrand disease (VWD), when…
Verbatim from this product's EMA label. Tap a section to expand.
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.
Summary of the safety profile During treatment with VEYVONDI the following adverse reactions may occur: hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF. 8 Tabulated list of adverse reactions Table 4 lists the adverse reactions reported in clinical trials, post-authorisation safety studies or post- marketing reporting.
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 4. Summary of adverse reactions reported in clinical trials, post-authorisation safety studies or post-marketing with VEYVONDI in von Willebrand disease MedDRA system organ class (SOC) Adverse reaction by preferred term (PT) Frequency category by subject Immune system disorders Anaphylactic reaction* Not known Nervous system disorders Headache Very common Dizziness Common Vertigo Common Dysgeusia Uncommon Tremor Uncommon Cardiac disorders Tachycardia Uncommon Vascular disorders Hypertension Common Deep venous thrombosis Uncommon Hot flush Uncommon Gastrointestinal disorders Vomiting Common Nausea Common Skin and subcutaneous tissue disorders Pruritus generalised Common General disorders and administration site conditions Chest discomfort Uncommon Infusion site paraesthesia Uncommon Infusion-related reaction (including tachycardia, flushing, rash, dyspnea, blurred vision)* Not known Investigations Electrocardiogram T wave inversion Uncommon Heart rate increased Uncommon * Adverse reactions identified during post-marketing surveillance.
Description of selected adverse reactions Hypersensitivity There is a possibility of developing hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, rhinoconjunctivitis, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) which may in some cases progress to anaphylaxis (including shock).
2). Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity reactions Hypersensitivity reactions (including anaphylaxis) have occurred.
Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock.
In case of shock, standard medical treatment for shock should be implemented. Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care.
Adequate medical treatment and provisions should be available for immediate use for a potential anaphylactic reaction, especially for patients with a history of allergic reactions. VEYVONDI contains trace amounts of mouse immunoglobulin G and hamster proteins (less than or equal to 2 ng/IU VEYVONDI).
Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins. VEYVONDI contains trace amounts of recombinant coagulation factor VIII. Thrombosis and embolism There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors for thrombosis including low ADAMTS13 levels.
Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care. In patients requiring frequent doses of VEYVONDI in combination with recombinant factor VIII, plasma level for FVIII:C activity should be monitored to avoid sustained excessive FVIII:C plasma level, which may increase the risk of thrombotic events.
1. 6 Known allergic reaction to mouse or hamster proteins.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Calculating dose VEYVONDI dose [IU] = dose [IU/kg] x body weight [kg] 4 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 […]
Patients with VWD, especially type 3, may very rarely develop neutralising antibodies (inhibitors) to von Willebrand factor. If such inhibitors occur, the condition may manifest itself as an inadequate clinical response. Such antibodies may occur in close association with hypersensitivity or anaphylactic reactions.
Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor. In all such cases, it is recommended that a specialised haemophilia centre be contacted. 9 Thrombogenicity There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors including low ADAMTS13 levels.
Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care. Immunogenicity The immunogenicity of VEYVONDI was assessed in clinical trials by monitoring the development of neutralising antibodies against VWF and FVIII, as well as binding antibodies against VWF, Furin, Chinese Hamster Ovary (CHO) protein and mouse IgG.
No treatment-emergent development of neutralising antibodies against human VWF or neutralising antibodies against human rFVIII was observed. One of the 132 subjects who received VEYVONDI peri-operatively in clinical trials developed treatment-emergent binding antibodies against VWF following a surgery for whom no adverse events or lack of haemostatic efficacy has been reported.
Binding antibodies against impurities such as rFurin, CHO-protein or mouse IgG were not observed after treatment with VEYVONDI. Paediatric population The frequency, type and severity of adverse reactions in children receiving VEYVONDI for the treatment of haemorrhage are expected to be the same as in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Any FVIII that would be administered along with VEYVONDI should be a pure FVIII product. A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events. Neutralising antibodies (inhibitors) Patients with VWD, especially type 3, may develop neutralising antibodies (inhibitors) to von Willebrand factor.
If the expected plasma level of (VWF:RCo) is not attained, or if bleeding is not controlled with an appropriate dose, an appropriate assay should be performed to determine if a von Willebrand factor inhibitor is present. In patients with high levels of anti-VWF neutralising antibodies, von Willebrand factor therapy may not be effective and other therapeutic options should be considered to establish haemostasis.
7 Treatment of VWD patients who have high-titer binding antibodies [due to previous treatment with plasma derived von Willebrand factor (pdVWF)] may require a higher dose to overcome the binding antibody effect and such patients could be managed clinically by administration of higher doses of vonicog alfa based on the PK data for each individual patient.
2% of the WHO recommended maximum daily intake of 2 g sodium for an adult, assuming a body weight of 70 kg and a dose of 80 IU/kg body weight. This is to be taken into consideration by patients on a controlled sodium diet. 1 mg/mL. Polysorbates may cause allergic reactions.