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



  1. Van Wyck DB. The natural history of iron deficiency in patients with dialysis-associated anemia: Analysis of the first 10 weeks without iron and comparison to LU98001. Clinical study report, 2000 and data on file: American Regent, Inc., Shirley, NY.
  2. Major A, Mathez-Loic F, Rohling R, Gautschi K, Brugnara C. The effect of intravenous iron on the reticulocyte response to recombinant human erythropoietin. Br J Haematol. 1997;98:292-294.
  3. Hsu CY, McCulloch CE, Curhan GC. Iron status and hemoglobin level in chronic renal insufficiency. J Am Soc Nephrol. 2002;13(11):283-2786.
  4. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis. 2006;47(suppl 3):S1-S146.
  5. Silverberg DS, Iaina A, Peer G, et al. Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis. 1996;27:234-238.
  6. Silverberg DS, Blum M, Agbaria V, Deutsch M, Irony D, Schwartz R. The effect of IV iron alone or in combination with low-dose erythropoietin in the rapid correction of anemia of chronic renal failure in the predialysis period. Clin Nephrol. 2001;55(3):212-219.
  7. Singh H, Reed J, Noble S. Effect of iron therapy in peritoneal dialysis patients receiving erythropoiesis stimulating agents for anemia: arandomized, controlled trial. Clin J Am Soc Nephrol. 2006;1(3):475-482.
  8. Federal Drug Administration. FDA strengthens safety information for erythropoiesis-stimulating agents (ESAs). FDA News. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html. Accessed February 4, 2009.
  9. Kimura T, Arai M, Masuda H, et al. Impact of a pharmacist-implemented anemia man¬agement in outpatients with end-stage renal disease in Japan. Biol Pharm Bull. 2004;27:1831-1833.
  10. Al-Momen AK, Huraib SO, Mitwalli AH, et al. Intravenous iron saccharate in hemodialysis patients receiving r-HuEPO. Saudi J Kidney Dis Transplant. 1994;5:168-172.
  11. Nyvad O, Danielson H, Madsen S. Intravenous iron-sucrose complex to reduce epoetin demand in dialysis patients. Lancet. 1994;344:1305-1306.
  12. Silverberg DS, Blum M, Agbaria Z, Peer G, Kaplan E, Iaina A. Intravenous ferric saccharate as an iron supplement in dialysis patients. Nephron. 1996;72:413-417.
  13. Gotloib L, Silverberg D, Fudin R, Shostak A. Iron deficiency is a common cause of anemia in chronic kidney disease and can often be corrected with intravenous iron. J Nephrol. 2006;19(2):161-167.
  14. Agarwal R, Rizkala A, Bastani B Kaskas M, Leehey D, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26:445-454.
  15. Sunder-Plassman G, Horl WH. Importance of iron supply for erythropoietin therapy. Nephrol Dial Transplant. 1995;10:2070-2076.
  16. Schaefer RM, Schaefer L. Management of iron substitution during r-HuEPO therapy in chronic renal failure patients. Erythropoiesis. 1992;3:71-75.
  17. Fishbane S, Frei GL, Maesaka J. Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron administration. Am J Kidney Dis. 1995;26:41-46.
  18. Macdougall IC, Tucker B, Thompson J, et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996;50:1694-1699.
  19. Sepandj F, Jindall K, West M, Hirsch D. Economic appraisal of maintenance parenteral iron administration in the treatment of anemia in chronic hemodialysis patients. Nephrol Dial Transplant. 1996;11:319-322.
  20. Taylor, JE, Peat N, Porter C, Morgan AG. Regular low-dose intravenous iron therapy improves response to erythropoietin in hemodialysis patients. Nephrol Dial Transplant. 1996;11:1079-1083.

 
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%).


Please see Full Prescribing Information.