1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2007.
  2. Danielson BG, Salmonson T, Derendorf H, et al. Pharmacokinetics of iron [III]-hydroxide complex after a single dose in healthy volunteers. Arzn-Forsch/Drug Res. 1996;46:615-621.
  3. Beshara S, Lundqvist H, Sundin J, et al. Kinetic analysis of 52Fe labelled iron (III) hydroxide sucrose complex following bolus administration using positron emission tomography. Brit J Haemat. 1999;104:288-295.
  4. Beshara S, Lundqvist H, Sundin J, et al. Pharmacokinetic analysis and red cell utilization of 52Fe/59Fe labelled iron (III) hydroxide sucrose complex following intravenous administration using positron emission tomography. Clinical study report, 1997 and data on file: American Regent, Inc., Shirley, NY.
  5. Charytan C, Quinibi W, Bailie W. Comparison of Intravenous Iron Sucrose to Oral Iron in the Treatment of Anemic Patients with Chronic Kidney Disease Not on Dialysis. Nephron Clin Pract. 2005, Vol.100, c55-c62.
  6. Van Wyck et al. A randomized controlled trial comparing IV iron sucrose to oral iron in anemic patients with non-dialysis dependent CKD. Kidney Int. 2005;68:2846-2856
  7. Aronoff GR, Bennett WM, Blumenthal S, Charytan C, Pennell JP, Reed J, Rothstein M, Strom J, Wolf A, VanWyck D, Yee J. Iron sucrose in hemodialysis patients: Safety and efficacy of iron replacement and maintenance therapy. Kidney Int. 2004; 66:1193-1198
  8. Van Zyl-Smit R, Moosa MR, Potgieter CD, Viljoen HG, Naicker S. A multicentre study to investigate the tolerance, safety and efficacy of intravenous iron sucrose in hemodialysis patients with anemia. Clinical study report, 1997 and data on file: American Regent, Inc., Shirley, NY. Abstract in Kidney Int. 1999; 55: 2130.
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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