wilate Pharmacokinetics During Repeat Dosing in Surgery

Understanding the pharmacokinetics of a VWF/FVIII complex; a two-component product

The effect of repeated dosing when the half-life of active components differs.

Similar Half-Lives

Wilate Accumulation Repeat Dosing Chart

Different Half-Lives

Wilate Accumulation Repeat Dosing Chart
  • When the half-life of component 1 (VWF) is shorter than that of component 2 (FVIII), and repeat dosing occurs to maintain a steady state for 1, accumulation of 2 may occur. 1
  • Large differences between VWF half-life and FVIII half-life may increase the risk of FVIII accumulation when repeat doses are administered, as in surgery1

Component Half-Life of VWF/FVIII Complexes2-4

Humate-P®

Terminal Half-life(t1/2) of FVIII:C in Any Type (hours)Terminal Half-life (t1/2) of VWF:RCo in Any Type (hours)Ratio Half-life (t1/2) of FVIII:C/VWF:RCo (hours/hours)Recommended Repeat Dosing (hours)
∼2510-132.2Every (6) 8-12

wilate

Terminal Half-life(t1/2) of FVIII:C in Any Type (hours)Terminal Half-life (t1/2) of VWF:RCo in Any Type (hours)Ratio Half-life (t1/2) of FVIII:C/VWF:RCo (hours/hours)Recommended Repeat Dosing (hours)
∼20∼161.3Every 12-14
*Patients with shorter VWF and FVIII half-lives may require dosing every 6 hours4.
Presentation of Humate-P half-life information is not intended to claim or imply inferiority, equivalence, or superiority to wilate in efficacy, safety, or other conditions of use.
  • The risk of thromboembolic events is particularly important in surgical situations when a VWD patient receives repeated doses of VWF/FVIII complexes.2
  • All VWF/FVIII complexes carry warnings and precautions regarding the risk of thromboembolic events in VWD patients.

Pharmacokinetics During Repeat Dosing in Surgery

wilate

Wilate Accumulation Chart

Humate-P

Humate Accumulation
wilate
Pharmacokinetic data from 28 VWD patients undergoing surgery
Humate P.
Pharmacokinetic data from 29 VWD patients undergoing elective surgery
  • VWF and FVIII plasma levels were determined 30 minutes before and after each infusion
  • Both VWF and FVIII plasma levels rise and fall in parallel during maintenance dose administrations
  • No accumulation of FVIII:C was observed over time5
  • VWF and FVIII plasma levels were determined 30 minutes before and after each infusion
  • Pre-infusion mean levels of FVIII before each maintenance dose progressively increased, in contrast to those of VWF which remained relatively stable6
Presentation of Humate-P pharmacokinetics information is not intended to claim or imply inferiority, equivalence, or superiority to wilate in efficacy, safety, or other conditions of use.

wilate Pharmacokinetics During Repeat Dosing in Surgery

Long Wilate Accumulation Chart
  • Average plasma peak and trough levels in 28 VWD patients undergoing surgery5
  • No accumulation of FVIII:C was observed over time
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7F920A1F-498E-4B69-8CA7-9AC36704C874 Created with sketchtool.

Low recommended loading and maintenance dosing make wilate easy and convenient to use.

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References
  1. Gill et al. Haemophilia. 2014;20(6):1-3.
  2. Kessler CM, Friedman K, Schwartz BA, Gill JC, Powell JS; for the wilate PK Study Investigators. The pharmacokinetic diversity of two von Willebrand factor (VWF)/factor VIII (FVIII) concentrates in subjects with congenital von Willebrand disease. Results from a prospective, randomized crossover study. Thromb Haemost. 2011;106:279-288
  3. wilate Full Prescribing Information. Hoboken, NJ: Octapharma USA Inc; 2015.
  4. Humate-P® [Antihemophilic Factor/von Willebrand Factor Complex (Human)] Lyophilized Powder for Reconstitution for Intravenous Use Only [full prescribing information]. Kankakee, IL: CSL Behring LLC; August 2013.
  5. Srivastava et al. Haemophilia. 2017;23(2):264-272.
  6. Lethagen et al. J Thromb Haemost. 2007;5:1420-1430.

Humate-P® is a registered trademark of CSL Behring.