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WILATE 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: 01/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2024 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution 06/2024 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution 12/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution 12/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .......................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ............................................................................................................
2 Geriatrics ............................................................................................................ 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX....................................................... 5 4 DOSAGE AND ADMINISTRATION ............................................................................... 1 Dosing Considerations ........................................................................................
2 Recommended Dose and Dosage Adjustment .................................................... 3 Reconstitution ..................................................................................................... 4 Administration .....................................................................................................
5 Missed Dose ....................................................................................................... 9 5 OVERDOSAGE............................................................................................................
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). Monitoring and Laboratory Tests The formation of inhibitors to FVIII in patients with hemophilia A treated with FVIII should be monitored. If the expected FVIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed (Bethesda test) to determine if FVIII inhibitors are present.
In patients with high levels of inhibitors, FVIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of patients with hemostatic disorders.
Peri-Operative Considerations See 4 DOSAGE AND ADMINISTRATION for instructions for prevention of bleeding in case of surgery or severe trauma. Sensitivity/Resistance As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
If allergic symptoms occur, patients should discontinue the administration immediately and contact their physician. If patients develop inhibitors to FVIII, the condition will manifest itself as an inadequate clinical response. Such antibodies may precipitate and may occur concomitantly to anaphylactic reactions.
Therefore, patients experiencing an anaphylactic reaction should be evaluated for the presence of inhibitors. In case of shock, the current medical standards for treatment of shock are to be observed. Skin See Sensitivity/Resistance above.
1 Pregnant Women Animal reproduction studies have not been conducted with VWF/FVIII. Based on the rare occurrence of hemophilia A in women, experience regarding the treatment during pregnancy is not available. Therefore, wilate® should be used during pregnancy only if clearly indicated.
– General). 1 Dosing Considerations After 24–48 hours of treatment, in order to avoid an excessive rise in FVIII:C, reduced doses and/or prolongation of the dose interval should be considered. 2 Recommended Dose and Dosage Adjustment Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.
wilate® Human von Willebrand factor (VWF) and human Coagulation Factor VIII (FVIII) Page 6 of 39 Unclassified / Non classifié The number of units of FVIII and VWF:RCo administered is expressed in IU, which are related to the current World Health Organization (WHO) standard for FVIII and VWF:RCo products.
FVIII and VWF:RCo activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to the International Standards for FVIII and VWF:RCo in plasma). Hemophilia A The dosage and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
One IU of FVIII activity is equivalent to that quantity of FVIII in 1 mL of normal human plasma. 5–2% of normal activity. 5 IU/kg The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Table 1 can be used to guide dosing during bleeds and surgery in adult patients and children older than 6 years. In the case of the following hemorrhagic events, the FVIII:C should not fall below the given plasma level in the corresponding period.
Table 1 Hemophilia A – Treatment Scheme for Hemorrhages and Surgery Degree of hemorrhage/ type of surgical procedure FVIII level required (%) (IU/dL) Frequency of doses (hours)/duration of therapy (days) Hemorrhage Mild hemorrhage: Early hemarthrosis, muscle bleed, nosebleed, oral bleed and other minor injuries 20–40 Repeat every 12 to 24 hours.
wilate® is contraindicated for patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 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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wilate® Human von Willebrand factor (VWF) and human Coagulation Factor VIII (FVIII) Page 14 of 39 Unclassified / Non classifié wilate® has been studied in 4 VWD patients (3 VWD type 3 and 1 VWD type 2B) during labour and delivery in one clinical study.
Two patients underwent vaginal delivery (type 3) and 2 patients had a cesarean section (type 3/type 2B). In this study all procedures were uneventful. 2 Breast-feeding It is not known whether wilate® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when wilate® is administered to a nursing mother.
3 Pediatrics Pediatrics (<12 years of age): There are insufficient data to recommend the use of wilate® in children below 12 years of age and in PUPs with hemophilia A. Studies have been conducted in children with VWD and show that there is no significant difference in the treatment from that recommended for adults (See 14 CLINICAL TRIALS).
4 Geriatrics Although some of the patients who participated in the wilate® studies were >65 years of age, no appropriate subgroup analyses were performed and therefore no safety or tolerability data regarding a geriatric population are available at this point.
1 Adverse Reaction Overview Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, erythema, pruritus, rash, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, chest pain, dyspnoea, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to a severe anaphylactic reaction (including shock).
Patients with hemophilia A may develop neutralizing antibodies (inhibitors) to FVIII. If such inhibitors occur, the condition will manifest as an insufficient clinical response. In such cases, it is recommended that a specialized hemophilia centre be contacted.
Based on previously published data from PUPs with severe hemophilia A treated with other concentrates, FVIII inhibitor rate is estimated to be 25–40%. In PTPs, there are insufficient data to estimate the rate of inhibitor development in patients commencing treatment with wilate®.
Published data, based on treatment with other FVIII products, estimate the rate of inhibitor development to be in the range of 2–3%. Data from ongoing and future studies with wilate® and from post-marketing reviews will provide more accurate information on the rate of inhibitor development associated with the transfer of patients to treatment with wilate®.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, 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 may be useful in identifying and approximating rates of adverse drug reactions in real-world use. VWD and Hemophilia A Safety data available from clinical studies with wilate® include data from 6 completed studies in hemophilia A and 9 completed studies in VWD and are summarized in this section.
In total, 310 individual patients (110 hemophilia patients and 200 VWD patients) were enrolled in these studies. 5 Mio IU wilate® from 95 batches were administered across all 15 studies, corresponding to approximately 16,425 exposure days.
Frequency of adverse events judged to be related to wilate® treatment are shown in Table 4. Table 4 Frequency of Treatment Related* Adverse Events by System Organ Class (All Studies) MedDRA standard System Organ Class ADRs (MedDRA Preferred Term) Number of unique patients with ADRs ADR rate (% of patients)† […]
At least 1 day, until the bleed as indicated by pain is resolved or healing is achieved. More extensive hemarthrosis, muscle bleed or hematoma 30–60 Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and disability are resolved.
Life threatening hemorrhage: cerebral hemorrhage, blunt trauma without visible bleeding site, severe abdominal bleed resp. internal bleeding, throat bleed 60–100 Repeat infusion every 8 to 24 hours until threat is resolved. Surgery Minor including tooth extraction 30–60 Every 24 hours, at least 1 day, until healing is achieved.
Major 80–100 (pre- and postoperative) Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a FVIII activity of 30% to 60%. FVIII = Coagulation factor VIII; IU = International units.
During the course of treatment, appropriate determination of FVIII:C levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (FVIII:C) is indispensable.
Individual patients may vary in their response to wilate® Human von Willebrand factor (VWF) and human Coagulation Factor VIII (FVIII) Page 7 of 39 Unclassified / Non classifié FVIII treatment, achieving different levels of in-vivo recovery (IVR) and demonstrating a different half-life (T1/2).
Prophylaxis For long-term prophylaxis against bleeding in patients with severe hemophilia A, doses of approximately 20 IU wilate®/kg BW should be given at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
There are insufficient data to recommend the use of wilate® in children below 12 years of age and in PUPs with hemophilia A. Von Willebrand disease Based on the clinical trial results, approximately 20–60 IU VWF:RCo/kg BW are given to achieve adequate hemostasis in case of bleeding.
For prevention of bleeding in case of surgery, wilate® should be given 1–2 hours before start of the surgical procedure (30–60 IU VWF:RCo/kg BW for minor surgery and 40–60 IU VWF:RCo/kg BW for major surgery) and, if required, every 12–24 hours after the intervention (20–40 IU VWF:RCo/kg BW for minor and major surgery).
Plasma level of VWF:RCo of ≥60 IU/dL (≥60%) and FVIII:C of ≥40 IU/dL (≥40%) should be achieved. The dosage should be adjusted according to the extent and location of the bleeding and/or the type of surgery. In VWD type 3 patients, especially in those with gastrointestinal (GI) bleedings, higher doses may be required.
Table 2 provides an overview of the recommended doses for the treatment of hemorrhages and for the prevention of bleeding during and after surgical procedures. Dosage recommendations are based on the actually administered doses that were shown to be efficacious in the clinical studies in VWD.
Table 2 wilate® Dosing for Treatment of Hemorrhages and in Surgery Type of VWD Indication Dosage (IU VWF:RCo/kg BW) Any type Minor hemorrhage* Loading dose 20–40 IU/kg, maintenance dose 20–30 IU/kg every 12–24hrs‡ Major hemorrhage† Loading dose 40–60 IU/kg, maintenance dose 20–40 IU/kg every 12–24hrs‡ Any type Minor surgery§ Loading dose 30–60 IU/kg, maintenance dose 20–40 IU/kg every 12–24 hours Major surgery# Loading dose 40–60 IU/kg, maintenance dose 20–40 IU/kg every 12–24 hours Treatment guidelines apply to all VWD types.
g. mild forms of epistaxis, oral bleeds, menorrhagia. g. GI bleeds, muscle bleeding, hemarthrosis, severe refractory epistaxis. ‡ This may need to be continued for up to 3 days for minor hemorrhages and 5–7 days for major hemorrhages. g.
dental surgery of 1 or more teeth […]