There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .
Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study.
BACKGROUND Currently available intravenous ( IV ) iron agents vary in indication , dosing regimens and safety profiles . Ferric carboxymaltose ( FCM ) is a stable , non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues . The objective of the present study was to evaluate the safety of FCM compared with st and ard medical care ( SMC ) in dialysis ( HD ) and non-dialysis-dependent ( NDD ) chronic kidney disease ( CKD ) patients . METHODS Adults 18 - 85 years of age with CKD were enrolled . NDD-CKD ( n = 204 ) patients received an undiluted IV dose of FCM ( 15 mg/kg to a maximum of 1000 mg IV ) and HD-CKD ( n = 50 ) patients received an undiluted IV push of 200 mg ~30 - 60 min into the dialysis session . Subjects r and omized to the SMC group ( n = 259 ) received treatment determined by the investigator that could include oral iron , IV iron or no iron . RESULTS Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated . Incidences of treatment-emergent adverse events were similar between the groups : 30.3 % ( 77 of 254 ) in the FCM group and 32.8 % ( 85 of 259 ) in the SMC group . Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate . There were no clinical ly significant differences in laboratory or clinical chemistry values or vital signs between the groups . There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin ( Hb ) improvement , including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of > 12 g/dL. CONCLUSION FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations
There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .