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Rivaroxaban (Xarelto°) for venous thromboembolism in children and adolescents

FEATURED REVIEW Rivaroxaban is the first oral factor Xa inhibitor to be granted marketing authorisation in the European Union for use in children and adolescents. In this situation, what benefit does rivaroxaban bring, compared to a heparin derivative or warfarin? What is its adverse effect profile in children and adolescents?
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  •  POSSIBLY HELPFUL  As of early 2022, according to the results of one trial in 500 patients, for those rare cases of venous thromboembolism occurring in children and adolescents, rivaroxaban has not been shown to have a more favourable harm-benefit balance than that of a heparin derivative (alone or followed by a vitamin K antagonist). In infants, the harm-benefit balance of rivaroxaban is uncertain, mainly because of an increased risk of bleeding. When parenteral administration of an anticoagulant, and the repeated blood sampling needed for laboratory monitoring, are factors leading to poor treatment compliance, orally administered rivaroxaban is an option for children over 2 years of age. For infants, rivaroxaban is an option which should only be used in the closely monitored context of a clinical research study. 

©Prescrire 1 July 2022

Source: "Rivaroxaban (Xarelto°) for venous thromboembolism in children and adolescents. An orally administered alternative" Prescrire International 2022; 31 (239): 173-175. Subscribers only.

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