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 .
Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha.
PURPOSE Unresponsiveness to erythropoiesis-stimulating agents , occurring in 30 % to 50 % of patients , is a major limitation to the treatment of chemotherapy-related anemia . We have prospect ively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin .  PATIENTS AND METHODS Between December 2004 and February 2006 , 149 patients with lung , gynecologic , breast , and colorectal cancers and > or= 12 weeks of planned chemotherapy were enrolled from 33 institutions . Patients were required to have hemoglobin < or= 11 g/L and no absolute or functional iron deficiency . All patients received darbepoetin 150 microg subcutaneously once weekly for 12 weeks and were r and omly assigned to sodium ferric gluconate 125 mg intravenously ( IV ) weekly for the first 6 weeks ( n = 73 ) or no iron ( n = 76 ) . Primary end point of the study was the percentage of patients achieving hematopoietic response ( hemoglobin > or= 12 g/dL or > or= 2 g/dL increase ) . RESULTS Hematopoietic response by intention-to-treat analysis was 76.7 % ( 95%CI , 65.4 % to 85.8 % ) in the darbepoetin/iron group and 61.8 % ( 95%CI , 50.0 % to 72.7 % ) in the darbepoetin group ( P = .0495 ) . Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations , hematopoietic responses in the darbepoetin/iron group ( n = 53 ) and in the darbepoetin-only group ( n = 50 ) were 92.5 % ( 95 % CI , 81.8 % to 97.9 % ) and 70 % ( 95 % CI , 55.4 % to 82.1 % ) , respectively ( P = .0033 ) . Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on . The safety profile was comparable in the two arms . CONCLUSION In patients with chemotherapy-related anemia and no iron deficiency , IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity
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 .