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Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response

Guy Young1, Anthonie W A Lensing2, Paul Monagle3,4

  • 1Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.

Journal of Thrombosis and Haemostasis : JTH
|April 5, 2020
PubMed

Insights

Pediatric venous thromboembolism (VTE) can be safely and effectively treated with bodyweight-adjusted rivaroxaban, available in tablet or suspension forms. This study validates these dosing regimens for children, ensuring appropriate VTE management.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Hematology

Background:

  • The EINSTEIN-Jr study demonstrated rivaroxaban's comparable efficacy and safety to standard anticoagulation for pediatric venous thromboembolism (VTE).
  • Rivaroxaban dosing in children was previously established using Phase 1 and 2 data and pharmacokinetic (PK) modeling.

Purpose of the Study:

  • To validate bodyweight-adjusted rivaroxaban dosing regimens (tablets and oral suspension) in children with VTE.
  • To assess the pharmacokinetic (PK) parameters and exposure-response relationships for rivaroxaban in pediatric patients.
  • To evaluate the safety and tolerability of rivaroxaban formulations in children.

Main Methods:

  • Pharmacokinetic (PK) modeling was used to derive steady-state plasma concentrations (AUC, Cmax, Ctrough) from sparse blood sampling in children.
  • Exposure-response relationships were analyzed to link PK parameters with clinical outcomes (recurrent VTE, bleeding, adverse events).
  • A taste-and-texture questionnaire assessed the acceptability of the rivaroxaban oral suspension formulation.

Main Results:

  • Pharmacokinetic exposures for rivaroxaban in children were found to be within the adult range.
  • No correlation was observed between PK parameters and efficacy, bleeding, or adverse event outcomes.
  • Both tablet and oral suspension formulations demonstrated similar results, with favorable acceptability and palatability for the suspension.

Conclusions:

  • Bodyweight-adjusted rivaroxaban regimens, administered via tablets or oral suspension, are validated for treating pediatric VTE.
  • These validated regimens provide appropriate and effective treatment options for children with VTE.
  • Rivaroxaban offers a safe and effective alternative to standard anticoagulation in the pediatric VTE population.
Abstract

Keywords:
anticoagulationbodyweight-adjusted dosingpediatric patientspharmacokineticsrivaroxabansuspensionvenous thromboembolism

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