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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IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® 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 the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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