Ferric carboxymaltose for the treatment of iron-deficiency anemia. [corrected].

INTRODUCTION: Anemic patients may benefit from the various intravenous iron replacement options available. Ferric carboxymaltose (FCM) is a new iron formulation (150 kDa) that can be given at high doses (20 mg/kg, up to 1000 mg) over a short period (≤ 15 min), without test dosing. AREAS COVERED: This paper reviews studies dealing with the efficacy and safety of FCM for treating anemia in relatively large numbers of patients, in addition to analyzing the differences regarding clinical conditions, iron doses, follow-up, comparators, and hematologic response targets. EXPERT OPINION: Overall, there is substantial evidence that FCM is effective in treating iron-deficiency anemia in many acute and chronic conditions, with a favorable benefit-risk profile. The efficacy of FCM for correcting anemia is similar to that of iron sucrose, and it is superior to oral iron or placebo in replenishing iron stores. Despite higher acquisition costs (as fewer administrations are needed), treatment with FCM (as well as with iron isomaltoside 1000 or ferumoxytol) seems to be cost-effective when compared to iron sucrose, and is more convenient for patients. There are, however, some aspects (such as hypophosphatemia) and important missing information (such as use in children and pregnant women) that need to be addressed for facilitating a widespread use of FCM.