Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study
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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.
KeywordsFerric carboxymaltose (FCM) Japanese patients Iron-deficiency anemia (IDA) Digestive disease Intravenous iron
The authors are grateful to the patients and their families for their contributions.
Compliance with ethical standards
Conflict of interest
The present study was performed as a Phase III study funded by Zeria Pharmaceutical Co., Ltd. Ito, Takahashi, and Suzuki received research funding from Zeria Pharmaceutical Co., Ltd. Ikuta received personal fees as a medical specialist from Zeria Pharmaceutical Co., Ltd. Masaki and Terauchi are employees of Zeria Pharmaceutical Co., Ltd.
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