1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2011.
  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:

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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