Indication:
Treatment of Iron Deficiency Anemia in Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Patients Receiving an Erythropoietin.

U.S. Clinical Trial- Study Results:
A multi-center, open label, historically controlled study of 101 chronic hemodialysis patients with iron deficiency anemia (77 treated with Venofer® [iron sucrose injection, USP] and 24 historical controls).  Venofer® treated patients received a total cumulative dose of 1000 mg (100 mg over 10 consecutive dialysis sessions).  See Dosage and Administration Section.^5,6

The Venofer® group showed significantly greater increases in mean hemoglobin from baseline to end of treatment (day 24) (p<.01).  Treatment with Venofer® also significantly increased serum ferritin (p=.0001) and transferrin saturation (p=.0016) at study endpoint compared with historical controls. ^5,6

Four of the 77 patients (5%) treated with Venofer® experienced possible or probable drug-related adverse events (transient taste sensation, diarrhea & abdominal pain, diarrhea and nausea, and constipation).  None were considered serious or resulted in discontinuation of treatment.  No hypersensitivity reactions were seen.^5,6 

Dosage & Administration:
Venofer® is administered by slow IV push of 100 mg undiluted over 2-5 minutes or by infusion of 100 mg diluted in 100 mL of normal saline over 15 minutes for 10 consecutive dialysis sessions for a total cumulative dose of 1,000 mg.⁵