Abstract
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 ≤ 1000 mg, administered intravenously
(i. v.) over ≤ 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
≥ 2.0 g/dl earlier (7 days compared with 14 days; p < 0.001), were more likely to
achieve an Hb rise ≥ 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.
Key words Anemia - Ferinject® - Ferric carboxymaltose, efficacy, safety - Intravenous iron -
Iron deficiency
