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WILLFACT is a brand name for Von Willebrand Factor. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Willfact is indicated in the prevention and treatment of haemorrhage or surgical bleeding in patients with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated. WILLFACT can be used for all age groups. WILLFACT should not be used in the treatment of Haemophilia A.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment of von Willebrand disease should be supervised by a physician experienced in the treatment of haemostatic disorders. 02 IU/mL (2 %). 4 IU/mL (40 %) should be achieved. 4 IU/mL (40 %). A single injection of von Willebrand factor alone does not induce a maximum rise of FVIII:C for at least 6-12 hours.
It cannot immediately correct the FVIII:C level. So, if the patient’s baseline plasma FVIII:C level is below this critical level, in all situations where a rapid correction of haemostasis should be achieved, such as treatment of haemorrhage, severe trauma or emergency surgery, it is necessary to administer a factor VIII product with the first injection of von Willebrand factor, in order to achieve a haemostatic plasma level of FVIII:C.
However, if an immediate rise in FVIII:C is not necessary, for example in a planned surgery, or if the baseline FVIII:C level is sufficient to ensure haemostasis, the physician may decide to omit the co-administration of FVIII at the first injection of VWF.
• Start of treatment: The first dose of Willfact is 40 to 80 IU/kg for the treatment of haemorrhage or trauma, in conjunction with the required amount of factor VIII product, calculated according to the patient's baseline plasma level of FVIII:C, in order to achieve an appropriate plasma level of FVIII:C, immediately before the intervention or as soon as possible after the onset of the bleeding episode or severe trauma.
In case of surgery, it should be given 1 hour before the procedure. An initial dose of 80 IU/kg of Willfact may be required, especially in patients with type 3 von Willebrand disease where maintenance of adequate levels may require higher doses than in other types of VWD.
For elective surgery, treatment with Willfact should start 12-24 hours before surgery and should be repeated 1 hour before the procedure. 4 IU/mL (40 %) before surgery. However, this should be confirmed in each patient. • Subsequent injections: If required, treatment should be continued with an appropriate dose of Willfact, 40 - 80 IU/kg per day in 1 or 2 injections daily over one to several days.
The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of bleeding and both VWF:RCo and FVIII:C levels. • Long-term prophylaxis: Willfact can be administered as long-term prophylaxis in a dose which is determined individually for each patient.
Summary of the safety profile During treatment with WILLFACT the following adverse reactions may occur: Allergic reactions and anaphylactic reactions (including shock in rare cases), thromboembolic events (mostly in patients with risk factors), inhibitor formation against VWF and administration site reactions.
Tabulated list of adverse reactions The table below provides an overview of adverse drug reactions observed in 6 clinical trials and one non-interventional post-marketing study, and from other post marketing sources. During the studies, 226 patients were exposed to WILLFACT for a total of 16 640 exposure days.
The adverse drug reactions were categorized according to the MedDRA System Organ Class (SOC), Preferred Term Level (PT) and frequency. Frequency of adverse event occurrence has been estimated 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).
For spontaneously reported post-marketing adverse reactions, the reporting frequency is categorised as not known. MedDRA Standard System Organ Class Adverse Drug Reactions (Preferred Term) Frequency by number of patients Blood and lymphatic system disorders Von Willebrand’s factor inhibition* Not known Hypersensitivity UncommonImmune system disorders Anaphylactic shock* Not known Dizziness UncommonNervous system disorders Paraesthesia, Hypoaesthesia Uncommon Hot flush UncommonVascular disorders Thromboembolic events* Not known Skin and subcutaneous tissue disorders Pruritus Uncommon Administration site reactions** (including Infusion site reaction, infusion site inflammation and vessel puncture site inflammation) Common Sense of oppression Uncommon Chills, Feeling cold Uncommon General disorders and administration site conditions Pyrexia* Not known * Reported during the post-marketing experience/surveillance with a frequency “not known”, per convention.
In actively bleeding patients it is recommended to co-administer a FVIII product with the von Willebrand factor product with a low FVIII content in a separate syringe as a first line treatment. Hypersensitivity As with any intravenous administration of a plasma-derived protein, hypersensitivity reactions are possible.
Patients must be closely monitored and carefully observed for any symptoms throughout the injection period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
If these symptoms occur, the administration should be discontinued immediately. In case of anaphylactic shock, standard medical treatment should be implemented. Transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). The measures taken may be of limited value against non-enveloped viruses such as hepatitis A and parvovirus B19.
g. haemolytic anaemia). Appropriate vaccination (hepatitis A and hepatitis B) should be considered for patients regularly receiving human plasma-derived von Willebrand factor. It is strongly recommended that every time Willfact is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Willfact doses between 40 and 60 IU/kg, administered two to three times per week, reduce the number of haemorrhagic episodes. • Outpatient treatment: Home treatment may be initiated, especially in cases of minor to moderate bleeding or during long term prophylaxis to prevent bleeding, with the treating physician’s approval.
The physician should ensure that appropriate training is provided and that the treatment is reviewed at predefined intervals. Paediatric population For each indication, dosing is based on bodyweight. The dose and duration of treatment should be adjusted to the clinical condition of the patient, and their VWF:RCo and FVIII:C plasma levels.
• Start of treatment: • For children below 6 years of age, the initial dose may be guided by the patient’s incremental recovery (IR) or, if IR data are not available, an initial dose between 60 and 100 IU/kg may be required with the goal to raise patients VWF:RCo levels to 100 IU/dL.
• For children above 6 years of age and adolescents, the posology is the same as adult patients. • Subsequent injections: For children and adolescents, subsequent doses should be individualised to the clinical condition and to the vWF:RCo levels and adjusted to the clinical response.
For elective surgery: • In children below 6 years of age, following a first dose administered 12 to 24 hours prior to the procedure, the repeated dose may be administered 30 minutes before the procedure. • For children above 6 years of age and adolescents the posology is the same as adult patients.
• Prophylaxis: For children and adolescents, the dose and the re administration frequency should be individualised to the patient’s incremental recovery and vWF:RCo levels and adjusted to the clinical response. 6. Willfact should be administered via the intravenous route at a maximum rate of 4 mL/minute.
** MedDRA High Level Group Terms. Description of selected adverse reactions Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lipothymia/malaise, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to severe anaphylaxis (including shock).
Patients with von Willebrand disease, especially type 3 patients, may very rarely develop neutralising antibodies (inhibitors) to von Willebrand factor. If such inhibitors occur, the condition will manifest itself as an inadequate clinical response.
Such antibodies may occur in close association with anaphylactic reactions. Therefore, patients experiencing anaphylactic reaction should be evaluated for the presence of an inhibitor. In all such cases, it is recommended that a specialised haemophilia centre be contacted.
Willfact is a von Willebrand factor product with a low FVIII content. Nevertheless, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors. 4. Paediatric population WILLFACT was assessed in 56 patients under 18 years of age, among them, 23 were below 6 years old, 21 were aged between 6 to 11 years old and 12 over 11 years old.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store ".
Thromboembolism Willfact is a von Willebrand factor product with a low FVIII content. Nevertheless, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors. Therefore, patients at risk must be monitored for early signs of thrombosis.
Prophylaxis against venous thromboembolism should be instituted according to the current recommendations. When using Willfact, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. Therefore, in patients requiring frequent dosing of WILLFACT, especially if in combination with a factor VIII product, plasma levels of FVIII:C should be monitored to avoid sustained excessive FVIII:C plasma levels, which may increase the risk of thromboembolic events.
Immunogenicity Patients with von Willebrand disease, especially type 3 patients, may develop neutralising antibodies (inhibitors) to von Willebrand factor. If the expected VWF:RCo activity plasma levels are 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 inhibitor, von Willebrand factor therapy may not be effective and other therapeutic options should be considered. Excipient related considerations (sodium content) This medicinal product contains sodium.
If more than 3300 IU is injected (more than 1 mmol sodium), this should be taken into consideration by patients on a controlled sodium diet (see section 2 for quantity per vial).