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P380. Safety and efficacy of bolus administered ferric carboxymaltose (500 mg) in the treatment of iron deficiency anaemia in IBD patients

D. Jakobsen1, M. Wiesenthal2, F. Hartmann3, A. Dignass4, S. Weber-Mangal5, J. Stein2, 11Krankenhaus Sachsenhausen, Crohn Colitis Center, Frankfurt, Germany, 2Crohn Colitis Zentrum Rhein-Main, Frankfurt, Germany, 3Marien Krankenhaus, Frankfurt, Germany, 4Apaglesion Markus Krankenhaus, Frankfurt, Germany, 5Vifor Pharma Germany, Munich, Germany

Background

Iron deficiency anemia (IDA) is a common hematological complication in IBD with potentially serious clinical consequences and often requires intravenous iron therapy. Ferric carboxymaltose (FCM) is a stable, non-dextran iron formulation which can be administered intravenously in large single doses to treat IDA.

Objective: To evaluate safety and efficacy of multiple or single bolus injection of 500 mg FCM administered within 2 minutes compared to standard infusion (15 min) of 500 mg FCM in IBD patients with IDA. Secondary endpoints were improvements in hemoglobin and iron indices.

Methods

Adult IBD patients with hemoglobin less than 12 g/dL and ferritin less than 30 ng/mL or transferrin saturation less than 16% were randomized to receive 500 mg FCM either as a single bolus (n = 40) or intravenous infusion over 15 min (n = 41).

Results

The increase in hemoglobin and iron indices was similar in both FCM groups. Both groups also reported similar incidences and types of adverse events and serious adverse events. Furthermore, transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in similar rates in both groups.

Conclusion

FCM administered in single doses of up to 500 mg within 2 minutes is safe, well tolerated and associated with improvements in hemoglobin and iron indices comparable to administration of FCM via infusion.