International Journal of Hematology

DOI: 10.1007/s12185-018-2529-9 Pages: 1-9

Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study

1. Asahikawa Medical University, Division of Gastroenterology and Hematology/Oncology, Department of Medicine

2. Kinshukai Infusion Clinic

3. Matsushima Clinic Shiodome

4. Zeria Pharmaceutical Co., Ltd., Clinical Research 2

5. Toho University Sakura Medical Center, IBD Center

Correspondence to:
Katsuya Ikuta
Tel: +81-166-68-2462
Email: ikuta@asahikawa-med.ac.jp

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Abstract

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.

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