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.