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In the absence of clinical data, rivaroxaban doses for thromboprophylaxis in post\u2010Fontan children aged 9\u2009years and older or \u226530\u2009kg were derived by a bridging approach that used physiologically\u2010based pharmacokinetic (PBPK) and population pharmacokinetic (popPK) models based on pharmacokinetic (PK) data from 588 pediatric patients and from adult patients who received 10\u00a0mg once daily for thromboprophylaxis after major orthopedic surgeries as a reference. Both models showed a tendency toward underestimating rivaroxaban exposure in post\u2010Fontan patients aged between 2 and 5\u2009years but accurately described rivaroxaban PK in post\u2010Fontan patients aged between 5 and 8\u2009years. Under the assumption that hepatic function is not impaired in post\u2010Fontan patients, PBPK and popPK simulations indicated that half of the rivaroxaban doses for the same body weight given to pediatric patients treated for acute VTE would yield in pediatric post\u2010Fontan patients exposures similar to the exposure observed in adult patients receiving 10\u00a0mg rivaroxaban once daily for thromboprophylaxis. Simulation\u2010derived doses (7.5\u00a0mg rivaroxaban once daily for body weights 30\u2013&lt;50\u2009kg and 10\u00a0mg once daily for body weights \u226550\u2009kg) were therefore included in the recent US label of rivaroxaban for thromboprophylaxis in children aged 2\u2009years and older with congenital heart disease who have undergone the Fontan procedure.<\/jats:p>","DOI":"10.1002\/psp4.12830","type":"journal-article","created":{"date-parts":[[2022,6,6]],"date-time":"2022-06-06T06:24:40Z","timestamp":1654496680000},"page":"1111-1121","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Model\u2010informed bridging of rivaroxaban doses for thromboprophylaxis in pediatric patients aged 9\u2009years and older with congenital heart disease"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8322-965X","authenticated-orcid":false,"given":"Stefan","family":"Willmann","sequence":"first","affiliation":[{"name":"Bayer AG, Research &amp; 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