Journal article

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

Guy Young, Anthonie WA Lensing, Paul Monagle, Christoph Male, Kirstin Thelen, Stefan Willmann, Joseph S Palumbo, Riten Kumar, Ildar Nurmeev, Kerry Hege, Fanny Bajolle, Philip Connor, Helene L Hooimeijer, Marcela Torres, Anthony KC Chan, Gili Kenet, Susanne Holzhauer, Amparo Santamaria, Pascal Amedro, Jan Beyer-Westendorf Show all

Journal of Thrombosis and Haemostasis | WILEY | Published : 2020

Abstract

BACKGROUND: Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling. METHODS: Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Base..

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