Indication:
Treatment of iron deficiency in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Patients Receiving or Not Receiving an Erythropoietin.

Clinical Trial Results:
A randomized, open-label, multi-center active-controlled study of the safety and efficacy of oral iron versus Venofer® (iron sucrose injection, USP) in NDD-CKD patients with or without erythropoietin therapy (n=182). Patients were treated with oral iron (ferrous sulfate 325 mg TID for 56 days) (n=91) or Venofer® (with or without an erythropoietin) (n=91). The Venofer® group received a total cumulative dose of 1,000 mg in divided doses over a 14 day period. (200 mg IV 5 times within a 14 day period or 500 mg as an infusion on days 1 and 14). See Dosage and Administration. ^5,8

A statistically greater proportion of Venofer® treated patients (39.2%) compared to oral iron patients (1.2%) had a clinically significant response defined as an increase in hemoglobin ≥1 g/dL, and ferritin ≥160 ng/mL at any time during the study. (p<.0001). ^5,8

A statistically greater proportion of Venofer® treated patients (44.3%) compared to oral iron (28%) had a clinically significant response as defined as an increase in hemoglobin ≥1 g/dL at any time during the study. (p=.0298). ^5,8

No serious adverse drug events were seen in patients administered Venofer® 200 mg IV over 2-5 minutes, but drug related hypotension, including one event considered serious, occurred in 2 females weighing less than 65 kg after 500 mg doses were given over 4 hours. ^5,8

GI complaints were the most frequently reported non-serious adverse drug event in both treatment groups. Transient taste disturbance was the most prominent GI complaint associated with Venofer®. Headache, myalgia, and hypotension were also associated with Venofer® administration. Constipation, diarrhea, nausea vomiting and dyspepsia were associated with oral iron administration. ^5,8

Dosage and Administration:
Venofer® is administered as a total cumulative dose of 1,000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period. There is limited experience with administration of an infusion of 500 mg of Venofer® diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 – 4 hours on day 1 and day 14; hypotension occurred in 2 of 30 patients treated. ⁵