Indication:
Treatment of iron deficiency anemia in Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Patients Receiving an Erythropoietin.

Clinical Trial- Study Results:
A multi-center, open label, randomized study of 121 treated peritoneal dialysis patients (75 received Venofer® [iron sucrose injection, USP]and erythropoietin; 46 received erythropoietin alone). Venofer® patients received a total cumulative dose of 1,000 mg in 3 divided doses within a 28 day period. See Dosage and Administration. ^1,5

A greater proportion of Venofer® and erythropoietin patients (59.1%) had an increase in hemoglobin of ≥1 g/dL at any time during the study compared to the patients who received erythropoietin alone (33.3%) (p<.05). ^1,5

There were no serious adverse events. However, 8 patients experienced at least 1 non-serious adverse event thought to be related to Venofer® with GI complaints (diarrhea and nausea) seen most frequently. ^1,5

Dosage & Administration:
Venofer® is administered as a total cumulative dose of 1,000 mg in 3 divided doses , given by slow intravenous infusion, within a 28 day period; 2 infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. The Venofer® dose should be diluted in a maximum of 250 mL of 0.9% NaCl. ⁵