High-purity, Human Von Willebrand Factor/Coagulation Factor VIII Complex Concentrate. Contains Von Willebrand Factor and Factor VIII in a 1:1 Activity Ratio.
Theraputic Indication
- Von Willebrand disease (VWD)
Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated.
- Haemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Presentation
Available in vials of: 500 IU
Key features of wilate®
- 14 years of clinical experience.
- Proven safety and efficacy in the treatment and prevention of bleeding, including surgical prophylaxis, for types 1, 2 and 3 von Willebrand disease (VWD) and haemophilia A1.
- No accumulation of FVIII after repeated dosing2 and no reports of thrombotic complications2,3.
- Two independent virus-inactivation steps1.
Dose
I-On demand treatment:
Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 IU/kg
The following can be used to guide dosing in bleeding episodes and surgery.
Hemorrhage
-Mild bleeding: 20-40 IU/Kg repeat infusion every 12-24 hours, at least for 1 day
-Moderate bleeding : 30-60 IU/Kg repeat infusion every 12-24 hours for 3-4 days
-Life threatening bleeding: 60-100 IU/Kg repeat infusion every 8-24 hours until threat is resolved
Surgery
-Minor surgery: 30-60 IU /KG repeat infusion every 24 hours at least for 1 day
-Major surgery: 80-100 IU/Kg pre-and postoperative, repeat infusion every 8-24 hours until adequate wound healing then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
II-Prophylaxis:
For long-term prophylaxis against bleedings in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
III-Paediatric population
There are insufficient data to recommend the use of Wilate in haemophilia A in children less than 6 years old.
Method of administration
Intravenous use.
The injection or infusion rate should not exceed 2-3 ml per minute.
Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Undesirable effects
Anaphylactic shock and Von Willebrand's factor inhibition are very rare
Hypersensitivity , Faver & Factor VIII inhibition in Previously Treated Patients (PTPs) are Uncommon
Factor VIII inhibition is common in Previously Untreated Patients (PUPs)
Shelf-life
3 years.
The stability of the reconstituted solution has been demonstrated for 4 hours at room temperature (max. +25°C). Nevertheless, to avoid microbial contamination, the reconstituted solution should be used immediately.
Special precautions for storage
Store powder and solvent vial in a refrigerator (2-8°C). Keep the vials in the outer carton in order to protect from light. Do not freeze.
The product can be stored at room temperature (max. +25°C) for 2 months. In this case the shelf-life expires 2 months after the product has been taken out of the refrigerator for the first time.
The reconstituted solution should be used on one occasion only. Any solution remaining should be discarded.
References
1. Wilate® Summary of Product Characteristics.
2. Srivastava A et al. Haemophilia 2017; 23:264-72.
3. Berntorp E et al. Haemophilia 2009; 15:122-30.