The safety and efficacy of high dose ferric carboxymaltose in patients with chronic kidney disease: A single center study.

Abstract

Ferric carboxymaltose (FCM) is a parenteral, dextran-free iron formulation designed to overcome the limitations of existing intravenous (IV) iron preparations. We investigated the safety and efficacy of high dose administration of FCM in our anemic chronic kidney disease (CKD) patients. It was a prospective observational study from June 2011 to August 2013. FCM was administered as IV infusion 1000 mg in 250 ml of normal saline over 15-30 min. Efficacy was evaluated by comparing the Hb and/or serum iron status at the first follow-up visit after the infusion with that at the baseline. A total of 500 infusions were administered to 450 patients. All patients had a successful administration of the FCM. None of the patients had any serious drug-related AE. AE of mild to moderate severity observed or reported after the infusion were: accelerated hypertension (0.2%), feeling abnormal (0.6%), headache and bodyaches (0.6% each), and infusion site reaction (0.8%). 261 patients had a follow up Hb, which showed an increase of 1.7 ± 1.5 g/dl after a period of 11 ± 7.2 weeks (P = 0.001); 188 (72%) patients had a rise in Hb of ≥1 g/dl. The increase in Hb was observed uniformly across all stages of CKD. Proportions of patients with an Hb of above 10 and 11 g/dl increased from 30.2% to 62.8% and 16.1% to 37.9%, respectively (P = 0.001). Iron status evaluation done in 44 patients after a follow up period of 15.1 ± 11.5 weeks showed increases in Hb of 1.6 ± 2.2 g/dl (P = 0.001), transferrin saturation of 9.1 ± 16.9% (P = 0.001), and ferritin of 406 ± 449 ng/ml (P = 0.001). We conclude high dose administration of FCM is safe and well-tolerated. It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.