A practical approach for iron repletion

Singh H, Reed J, Noble S, Cangiano J, Van Wyck DB for the United States Iron Sucrose (Venofer®) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006;1:475-482

Background:
A randomized, controlled, multicenter trial in anemic patients (N=126) with peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) compared the safety and efficacy of combined Venofer® (iron sucrose injection, USP) and erythropoiesis stimulating agent (ESA) therapy (n=80) versus ESA therapy alone (n=46).

Patients in the Venofer® group received 1000 mg IV iron in divided doses over a 28-day period as a 300 mg infusion in 250 mL normal saline over 1.5 hours on days 1 and 15 and a 400 mg infusion in 250 mL normal saline over 2.5 hours on day 29.

Measures:

  • Establish the adjuvant efficacy of IV iron
  • Determine the safety of iron sucrose at individual doses of 300 mg and 400 mg
  • Evaluate the relationship between baseline iron indices-ferritin, and TSAT values-and likelihood of response to IV iron challenge

Results:

  • Peak Hb increase was higher in patients receiving Venofer® plus ESA than in patients treated with ESA alone (1.3 g/dL vs .7 g/dL, respectively; P=.0028) (primary therapeutic end point)
  • Anemia intervention occurred later (59 days vs 34 days, P=.0137) and less often (1 of 66 [1.3%] vs 5 of 30 [16.7%]) in Venofer® treated patients*
  • Baseline TSAT and ferritin showed no diagnostic utilization in determining iron response
  • No serious adverse drug related events
*Anemia intervention defined as an increase in ESA dose, administration of nonprotocol IV iron or red blood cell transfusion.




Conclusions:

  • Venofer® (iron sucrose injection, USP) administered as a 300 mg or 400 mg infusion is well tolerated and provides a practical approach for iron repletion
  • Baseline iron status (TSAT, ferritin) did not predict responsiveness to IV iron treatment


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American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


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