Surgery

wilate provides effective surgical prophylaxis
with low dosing1.

Mean Daily Dose of wilate in Major and Minor Surgeries

Wilate Srivastava
  • The mean total loading dose was 51.4 IU VWF:RCo/kg per infusion (median 52.1)
  • The mean maintenance dose was 28.5 IU VWF:RCo/kg per infusion (median 28.5)
  • In surgical studies with Humate-P®, the median loading dose was 82.3 IU VWF:RCo/kg per infusion;
    the median maintenance dose was 52.8 IU VWF:RCo/kg per infusion

 

Hemostatic Efficacy by Type of Surgery and Type of VWD1

By type of surgery

Efficacy assessment*% Success
Minor (N-9)100% (9/9)
Major (N-21)95.2% (20/21)
All surgeries (N-30)96.7% (29/30)
*Based on the derived overall assessment, derived from the intra- and postoperative assessment of the IDMC, Independent Data Monitoring Committee.
† Two patients were enrolled for 2 surgeries each; therefore, there were 28 individual patient. Efficacy was excellent or good in all pediatric procedures (3 surgeries in 3 patients) By type of VWB There were no thromboembolic events; no antithrombotic agents were administered.
Efficacy assessment*% Success
Minor (N-9)100% (9/9)
Major (N-21)95.2% (20/21)
All surgeries (N-30)96.7% (29/30)
*Based on the derived overall assessment (derived from the intra- and postoperative assessment of the IDMC, based on blood loss, transfusion requirements, and postoperative bleeding and oozing). IDMC, Independent Data Monitoring Committee.
Two patients were enrolled for 2 surgeries each; therefore, there were 28 individual patient.

wilate Dosing for Perioperative Management of Bleeding in Children and Adults2.

Minor Surgery (including tooth extractions)

Loading Dosage (IU VWF:RCo/kg BW)Maintenance Dosage (IU VWF:RCo/kg BW)aTherapeutic Goal
30-60 IU/kg within 3 hours of the start of the surgical procedure15-30 IU/kg of half the loading dose every 12-24 hoursb,cVWF:RCo peak level of 50% after loading dose and trough level of >30% during maintenance doses until wound healingd

Major Surgery

Loading Dosage (IU VWF:RCo/kg BW)Maintenance Dosage (IU VWF:RCo/kg BW)aTherapeutic Goal
40-60 IU/kg within 3 hours of the start of the surgical procedure20-40 IU/kg of half the loading dose every 12-24 hoursb,cVWF:RCo peak level of 100% after loading dose and trough level of >50% during maintenance doses until wound healingd
aThis may need to be continued for up to 3 days for minor surgeries and for 6 days or more for major surgeries (until wound healing is achieved).
bIt is recommended to administer at least 2 maintenance doses within the first 24 hours after the start of the surgery.
cIn vivo recovery and t1/2 VWF:RCo/FVIII:C were 1.9% per IU/kg and 15.8 hours/2.2% per IU/kg and 19.6 hours, respectively.
dIn order to decrease the risk of perioperative thrombosis, FVIII activity levels should not exceed 250%.
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wilate showed no accumulation of FVIII during repeat dosing in surgery.

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References
  1. Srivastava A, et al. Haemophilia. 2017;23(2):264-272. 2. wilate Full Prescribing Information. Hoboken, NJ: Octapharma; rev 2015.