Iron-deficiency anemia (IDA) accounts for majority of
anemia. Although
iron replacement
therapy is effective, in Japan, conventional
iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations.
Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV
iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on
hemoglobin and serum
ferritin levels were included. Eligible subjects were administered FCM until the total calculated
iron dose (1000 or 1500 mg) was achieved over intervals of at least 1 week. A single
iron dose was 500 mg. In the full analysis set (n = 39), the incidence of adverse events and
adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV
iron. The mean change from baseline (10.39 g/dL) to the highest observed
hemoglobin level was 3.31 g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.