{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T04:03:41Z","timestamp":1779249821259,"version":"3.51.4"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T00:00:00Z","timestamp":1684454400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T00:00:00Z","timestamp":1684454400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Res"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Iron deficiency is the primary cause of anemia in children. Intravenous (IV) iron formulations circumvent malabsorption and rapidly restore hemoglobin.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This Phase 2, non-randomized, multicenter study characterized the safety profile and determined appropriate dosing of ferric carboxymaltose (FCM) in children with iron deficiency anemia. Patients aged 1\u201317 years with hemoglobin &lt;11\u2009g\/dL and transferrin saturation &lt;20% received single IV doses of undiluted FCM 7.5\u2009mg\/kg (<jats:italic>n<\/jats:italic>\u2009=\u200916) or 15\u2009mg\/kg (<jats:italic>n<\/jats:italic>\u2009=\u200919).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The most common drug-related treatment-emergent adverse event was urticaria (in three recipients of FCM 15\u2009mg\/kg). Systemic exposure to iron increased in a dose-proportional manner with approximate doubling of mean baseline-corrected maximum serum iron concentration (157\u2009\u00b5g\/mL with FCM 7.5\u2009mg\/kg; and 310\u2009\u00b5g\/mL with FCM 15\u2009mg\/kg) and area under the serum concentration\u2013time curve (1901 and 4851\u2009h\u00b7\u00b5g\/mL, respectively). Baseline hemoglobin was 9.2 and 9.5\u2009g\/dL in the FCM 7.5 and 15\u2009mg\/kg groups, respectively, with mean maximum changes in hemoglobin of 2.2 and 3.0\u2009g\/dL, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In conclusion, FCM was well tolerated by pediatric patients. Improvements in hemoglobin were greater with the higher dose, supporting use of the FCM 15\u2009mg\/kg dose in pediatric patients (Clinicaltrials.gov NCT02410213).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Impact<\/jats:title>\n                <jats:p><jats:list list-type=\"bullet\">\n                  <jats:list-item>\n                    <jats:p>This study provided information on the pharmacokinetics and safety of intravenous ferric carboxymaltose for treatment of iron deficiency anemia in children and adolescents.<\/jats:p>\n                  <\/jats:list-item>\n                  <jats:list-item>\n                    <jats:p>In children aged 1\u201317 years with iron deficiency anemia, single intravenous doses of ferric carboxymaltose 7.5 or 15\u2009mg\/kg increased systemic exposure to iron in a dose-proportional manner, with clinically meaningful increases in hemoglobin.<\/jats:p>\n                  <\/jats:list-item>\n                  <jats:list-item>\n                    <jats:p>The most common drug-related treatment-emergent adverse event was urticaria.<\/jats:p>\n                  <\/jats:list-item>\n                  <jats:list-item>\n                    <jats:p>The findings suggest that iron deficiency anemia in children can be corrected with a single intravenous dose of ferric carboxymaltose and support use of a 15\u2009mg\/kg dose.<\/jats:p>\n                  <\/jats:list-item>\n                <\/jats:list><\/jats:p>\n              <\/jats:sec>","DOI":"10.1038\/s41390-023-02644-9","type":"journal-article","created":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T06:02:15Z","timestamp":1684476135000},"page":"1547-1554","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Safety, pharmacokinetics, and pharmacodynamics of intravenous ferric carboxymaltose in children with iron deficiency anemia"],"prefix":"10.1038","volume":"94","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1626-1283","authenticated-orcid":false,"given":"Bartosz","family":"Korczowski","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colm","family":"Farrell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Falone","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Blackman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trudy","family":"Rodgers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,5,19]]},"reference":[{"key":"2644_CR1","doi-asserted-by":"publisher","first-page":"1211","DOI":"10.1016\/S0140-6736(17)32154-2","volume":"390","author":"GBD 2016 Disease and Injury Incidence and Prevalence Collaborators.","year":"2017","unstructured":"GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. 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