Ferric carboxymaltose (FCM, Ferinject) was effective and well tolerated in the 
treatment of iron-deficiency anemia (IDA) in nine, Phase III, randomized, 
controlled, multicenter trials in a diverse range of indications, including 
patients with inflammatory bowel disease (IBD), post-partum anemia (PPA) or 
abnormal uterine bleeding (AUB), chronic heart failure (CHF), 
non-dialysis-dependent chronic kidney disease (CKD) and those undergoing 
hemodialysis (HD). In most trials, patients received either FCM doses of < or = 
1000 mg, administered intravenously (i.v.) over < or = 15 min. or oral ferrous 
sulfate (FeSulf) 325 mg (65 mg iron), three times daily (t.i.d.), or 304 mg (100 
mg iron), twice daily (b.i.d.). In one trial, patients on HD received 200 mg 
i.v. of either FCM or iron sucrose (ISC), two-to-three times weekly. In a pilot 
study in patients with CHF and CKD, patients received 200 mg of FCM by push 
injection compared with 200 mg of ISC slow injection. FCM was usually 
administered until the patient's calculated total iron replacement dose was 
achieved. Treatment with FCM improved indices of anemia (hemoglobin [Hb], 
ferritin and transferrin saturation [TSAT] values). In patients on HD with IDA 
secondary to CKD, FCM demonstrated comparable efficacy to ISC in achieving an 
increase in Hb. In patients with IBD or PPA, improvements in Hb levels were more 
rapid with FCM than with FeSulf. Patients with PPA receiving FCM compared with 
those receiving oral iron achieved an Hb rise > or = 2.0 g/dl earlier (7 days 
compared with 14 days; p < 0.001), were more likely to achieve an Hb rise > or = 
3.0 g/dl at any time beginning at day 14 (86.3% compared with 60.4%; p < 0.001), 
and achieve an Hb > 12.0 g/dl at the end of the study (Day 42; 90.5% compared 
with 68.6%, p < 0.01). Serum ferritin increased in the i.v. FCM treatment group, 
but not in the oral iron group. Differences between groups were significant at 
each study interval. TSAT increased significantly at every interval in both 
groups; however, FCM-treated patients showed higher TSAT at each interval after 
the first week. FCM improved patient quality of life to an equivalent extent to 
oral FeSulf in patients with IBD or PPA, and to a greater extent than oral 
FeSulf in women with AUB. FCM also improved quality of life as well as 
functional symptoms and exercise capacity in patients with CHF. Safety data from 
more than 3000 patients showed that FCM was well tolerated. No safety concerns 
have been identified in breastfed infants of mothers receiving FCM. FCM is, 
therefore, an effective and well-tolerated option in the treatment of IDA.