Abstract
Background. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy. Ferric carboxymaltose (FCM) is a stable, nondextran iron formulation administered intravenously in large single doses to treat IDA. Objective. Two open-label, randomized, placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients. Secondary endpoints were improvements in hemoglobin and iron indices. Design and Patients. Adults with hemoglobin ≤12 g/dL, ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30% were randomized to receive single (n = 366) or weekly (n = 343) FCM or SMC (n = 360 and n = 366). Results. Significantly greater (P ≤ 0.001) increases in hemoglobin and iron indices occurred in FCM groups versus SMC. In the multidose study, up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators. FCM and SMC groups had similar incidences and types of adverse events and serious adverse events. Transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in the FCM groups. Conclusion. Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min. Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations.
Highlights
Iron deficiency anemia (IDA) is a common hematological complication with a prevalence of 2% among adult men and 9–20% among adult women depending on race and ethnicity [1]
IDA occurs in several medical conditions including inflammatory bowel disease (IBD) and chronic kidney disease (CKD), in association with cancer and its treatment, and in cases of acute blood loss resulting from gastrointestinal (GI) bleeding, trauma, surgery, and obstetrics/gynecology conditions [2]
IV iron is recommended for hemodialysis-dependent CKD patients due to frequent blood losses on dialysis machines and Anemia difficulty utilizing oral iron [9, 10] and is an option for treatment of predialysis CKD patients [9]
Summary
Iron deficiency anemia (IDA) is a common hematological complication with a prevalence of 2% among adult men and 9–20% among adult women depending on race and ethnicity [1]. While oral iron is typically considered first-line treatment, high-dose intravenous (IV) iron therapy has a role in the treatment of varied clinical situations associated with IDA. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy. Two open-label, randomized, placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients. Greater (P ≤ 0.001) increases in hemoglobin and iron indices occurred in FCM groups versus SMC. Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min. Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations
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