Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease
Iron-deficiency anemia is the most common reason for worsening of the anemia characteristically seen in chronic kidney disease (CKD). Ferric carboxymaltose (FCM) is a macromolecular hydroxide ferric carbohydrate complex that allows high-dose iron to be administered parenterally for gradual, controll...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-10-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2022.967233/full |
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| author | Patricia Garcia-Ortega Ines Jimenez-Lozano Álejandro Cruz Aurora Fernandez Polo Mercedes Lopez Gema Ariceta Gema Ariceta |
| author_facet | Patricia Garcia-Ortega Ines Jimenez-Lozano Álejandro Cruz Aurora Fernandez Polo Mercedes Lopez Gema Ariceta Gema Ariceta |
| author_sort | Patricia Garcia-Ortega |
| collection | DOAJ |
| description | Iron-deficiency anemia is the most common reason for worsening of the anemia characteristically seen in chronic kidney disease (CKD). Ferric carboxymaltose (FCM) is a macromolecular hydroxide ferric carbohydrate complex that allows high-dose iron to be administered parenterally for gradual, controlled release. The aim of this study was to retrospectively evaluate the safety and effectiveness of FCM treatment in pediatric patients with CKD non-dependent of hemodialysis, seen at a tertiary hospital. Data were collected on demographics, dosage, infusion time, laboratory results, and tolerability of the medicinal product. A total of 79 patients (40.5% girls) were included; the median age [25th percentile (P25) to 75th percentile (P75)] was 9 years (5–13). Laboratory results at 15–45 days post-infusion revealed a median increase of 1.4 g/dL (0.9–1.9) in hemoglobin, 224 μg/L (136–378.5) in ferritin, 37 μg/dL (17.5–71) in serum iron, and 18% (9.3–27.8) in transferrin saturation. All patients tolerated FCM infusions well, and no serious hypersensitivity reactions or anaphylactic reactions were observed. Only one adverse event was identified: drug extravasation at the end of the infusion in a 16-year-old patient. These data provide further evidence for the use of FCM as a safe and effective therapeutic option in pediatric patients with CKD, based on the low incidence of adverse effects, minor intervention required, and anemia improvement based on laboratory results. |
| first_indexed | 2024-04-13T23:14:28Z |
| format | Article |
| id | doaj.art-cad746f44ee44122ad5d348ae4bc9ac0 |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-04-13T23:14:28Z |
| publishDate | 2022-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-cad746f44ee44122ad5d348ae4bc9ac02022-12-22T02:25:28ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602022-10-011010.3389/fped.2022.967233967233Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney diseasePatricia Garcia-Ortega0Ines Jimenez-Lozano1Álejandro Cruz2Aurora Fernandez Polo3Mercedes Lopez4Gema Ariceta5Gema Ariceta6Department of Pharmacy, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pharmacy, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pediatric Nephrology, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pharmacy, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pediatric Nephrology, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pediatric Nephrology, Vall d'Hebron University Hospital, Barcelona, SpainDepartment of Pediatrics, Autonomous University of Barcelona, Barcelona, SpainIron-deficiency anemia is the most common reason for worsening of the anemia characteristically seen in chronic kidney disease (CKD). Ferric carboxymaltose (FCM) is a macromolecular hydroxide ferric carbohydrate complex that allows high-dose iron to be administered parenterally for gradual, controlled release. The aim of this study was to retrospectively evaluate the safety and effectiveness of FCM treatment in pediatric patients with CKD non-dependent of hemodialysis, seen at a tertiary hospital. Data were collected on demographics, dosage, infusion time, laboratory results, and tolerability of the medicinal product. A total of 79 patients (40.5% girls) were included; the median age [25th percentile (P25) to 75th percentile (P75)] was 9 years (5–13). Laboratory results at 15–45 days post-infusion revealed a median increase of 1.4 g/dL (0.9–1.9) in hemoglobin, 224 μg/L (136–378.5) in ferritin, 37 μg/dL (17.5–71) in serum iron, and 18% (9.3–27.8) in transferrin saturation. All patients tolerated FCM infusions well, and no serious hypersensitivity reactions or anaphylactic reactions were observed. Only one adverse event was identified: drug extravasation at the end of the infusion in a 16-year-old patient. These data provide further evidence for the use of FCM as a safe and effective therapeutic option in pediatric patients with CKD, based on the low incidence of adverse effects, minor intervention required, and anemia improvement based on laboratory results.https://www.frontiersin.org/articles/10.3389/fped.2022.967233/fullpediatricskidney diseaseintravenous ironferric carboxymaltoseiron deficiencyanemia |
| spellingShingle | Patricia Garcia-Ortega Ines Jimenez-Lozano Álejandro Cruz Aurora Fernandez Polo Mercedes Lopez Gema Ariceta Gema Ariceta Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease Frontiers in Pediatrics pediatrics kidney disease intravenous iron ferric carboxymaltose iron deficiency anemia |
| title | Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| title_full | Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| title_fullStr | Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| title_full_unstemmed | Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| title_short | Safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| title_sort | safety and effectiveness of ferric carboxymaltose intravenous therapy in pediatric patients with chronic kidney disease |
| topic | pediatrics kidney disease intravenous iron ferric carboxymaltose iron deficiency anemia |
| url | https://www.frontiersin.org/articles/10.3389/fped.2022.967233/full |
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