Administration Protocol for Wilate
Wilate is administered intravenously after reconstitution, with dosing based on VWF:RCo units per kilogram body weight, typically ranging from 20-80 IU/kg depending on the clinical indication (bleeding treatment, surgical prophylaxis, or routine prophylaxis). 1, 2
Reconstitution and Route
- Wilate must be reconstituted from lyophilized powder to solution before administration 1
- Administer only via intravenous injection after proper reconstitution 1, 2
- Infusion speed should be carefully controlled, as adverse events have been associated with rapid infusion rates 1
Dosing by Clinical Indication
On-Demand Treatment of Bleeding Episodes
Gastrointestinal bleeding: Higher doses required at mean 44 IU/kg with longer treatment duration (mean 4 days) 2
Severe bleeding: May require up to 50-80 IU/kg depending on severity and location 2, 3
Surgical Prophylaxis
Minor surgery: Target VWF:RCo levels of 50-60 IU/dL and FVIII:C levels of 40-50 IU/dL 5
- Typical dosing: 40-50 IU/kg perioperatively 3
Major surgery: Target VWF:RCo levels of 100 IU/dL and FVIII:C levels of 80-100 IU/dL 5
- Mean total perioperative dose: approximately 848.6 IU/kg administered over the surgical period 4
Routine Prophylaxis
- Standard prophylactic regimen: 20-50 IU/kg administered 1.9 times per week (approximately twice weekly) 2
- Mean prophylactic dose of 27.4 IU/kg has demonstrated reduction in bleeding frequency from 4.5 to 1.4 bleeds per month 2
Pharmacokinetic Considerations
- VWF:RCo half-life: Average 10.4 hours (terminal half-life 15.8 hours) 6
- In vivo recovery: Mean 1.89 IU/dL per IU/kg for VWF:RCo 6
- Wilate demonstrates parallel decay curves for both VWF:RCo and FVIII:C over time, unlike some other concentrates that show FVIII plateau 6
- The physiological 1:1 ratio of VWF to FVIII prevents notable FVIII accumulation even with treatment ≥3 days 1
Pediatric Dosing
- Children under 6 years: Same weight-based dosing as adults (20-50 IU/kg for bleeding episodes) 3
- Efficacy and dosing requirements in children do not differ significantly from the adult population 2, 3
- In vivo recovery profiles in pediatric patients are consistent with adult data 3
Critical Safety Considerations
- Infusion-related reactions: Slow infusion rate to minimize adverse events; 50% of reported adverse events were retrospectively attributed to excessive infusion speed 1
- Thrombotic risk: While rare (0.44% adverse event rate per infusion), monitor patients with thrombotic risk factors 1
- No FVIII accumulation: The 1:1 VWF:FVIII ratio prevents the problematic FVIII accumulation seen with some other concentrates 1, 6
Monitoring Parameters
- Assess VWF:RCo and FVIII:C levels to guide dosing, particularly in surgical settings 5, 6
- For surgical procedures, monitor coagulation parameters both during and after the procedure 5
- The parallel decay of VWF and FVIII facilitates easier laboratory monitoring compared to concentrates with disproportionate ratios 6