Take IV Iron Therapy to a proven place: No dextrans. No bolded or black box warnings. No test dose!







  1. Hsu CY, McCulloch CE, Curhan GC. Iron status and hemoglobin level in chronic renal insufficiency. J Am Soc Nephrol. 2002;13(11):2728-2786.
  2. Heras M, Sandoval JS, Garrido J, et al. Effect of intravenous iron administration on oxidative stress in patients with CRF on hemodialysis under erythropoietin therapy [abstract]. J Am Soc Nephrol. 2000;11:272A.
  3. Drueke T, Witko-Sarsat V, Massy Z, et al. Iron therapy, advanced oxidation protein products, and carotid artery intima-media thickness in end-stage renal disease. Circulation. 2002;106:2212-2217.
  4. Parkkinen J, von Bonsdorff L, Peltonen S, et al. Catalytically active iron and bacterial growth in serum of haemodialysis patients after i.v. iron-saccharate administration. Nephrol Dial Transplant. 2000;15:1827-1834.
  5. Kooistra MP, Kersting S, Gosriwatana I, et al. Nontransferrin-bound iron in the plasma of haemodialysis patients after intravenous iron saccharate infusion. Eur J Clin Invest. 2002;32(suppl 1):36-41.
  6. Van Wyck D, Anderson J, Johnson K. Nephrol Dial Transplant. 2004;19:561-565.
  7. Kirk EA, Heinecke JW, LeBoeuf RC. Iron overload diminishes atherosclerosis in apoE-deficient mice. J Clin Invest. 2001;107:1545-1553.
  8. Meyers DG. The iron hypothesis-does iron cause atherosclerosis? Clin Cardiol. 1996;19:925-929.




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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