1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2011.
  2. Data on file. American Regent, Inc., Shirley, NY.
  3. Danielson BG. Oral and intravenous iron supplementation in renal anemic patients on EPO treatment. Clinical study report, 1993a and data on file. American Regent, Inc., Shirley, NY.
  4. Danielson BG. Supplementation with IV iron sucrose complex in patients with renal anemia. Clinical study report, 1993b and data on file. American Regent, Inc., Shirley, NY.
  5. 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.
  6. Nyvad O, Danielson H, Madsen S. Intravenous iron-sucrose complex to reduce epoetin demand in dialysis patients. Lancet. 1994;344:1305-1306.
  7. 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.
  8. Macdougall IC, Chandler G, Armstrong A, Breen C, Harchowal J, Cavill I. Characterization of iron availability from three different IV iron preparations in dialysis patients. Clinical study report, 1999. Abstract from the 30th Annual Meeting and Scientific Exposition of the American Society of Nephrology. November 2-5, 1997, San Antonio, Texas.
  9. Al-Wakeel JS, Malik GH, Al-Mohaya S, et al. Intravenous iron supplementation in patients treated with erythropoietin. Indian J Nephrol. 1997;7:91-96.
  10. Tarng D-C, Huang TP, Chen TW. Mathematical approach for estimating iron needs in hemodialysis patients on erythropoietin therapy. Am J Nephrol. 1997;17:158-164.
  11. 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.
  12. Charytan C, Levin N, Al-Saloum M, et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Clinical study report, 1999. Am J Kidney Dis. 2001;37(2):300-307.
  13. Van Wyck DB, Cavallo G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36:88-97.
  14. Kosch M, Bahner U, Bettger H, Matzkies F, Teschner M, Schaefer RM. A randomized, controlled, parallel-group trial on efficacy and safety of iron sucrose Venofer® vs. iron gluconate (Ferrlecit®)in hemodialysis patients treated with rHuEpo. Nephrol Dial Transplant. 2001;16:1239-1244.
  15. Jones CH, Richardson D, Ayers S, Newstead CG, Will EJ, Davison AM. Percentage hypochromic red cells and the response to intravenous iron therapy in anemic hemodialysis patients. Nephrol Dial Transplant. 1998;13:2873-2876.
  16. Macdougall IC, Chandler G, Elston O, Harchowal J. Beneficial effects of adopting an aggressive intravenous iron policy in a hemodialysisunit. Am J Kidney Dis. 1999;34:S40-S48.
  17. Wakefield RM, Haynes PG, Lee MA, Brocklebank JT, Fitzpatrick MM. Intravenous iron saccharate therapy in paediatric end stage renal failure patients. Abstract from the IIIrd Spring Meeting of the Royal College of Paediatrics and Child Health. April 12-15, 1999.
  18. Andrade LJ, Garica MI, Acuna GD, Fogliati MM, Martinez RD, Loredo JP, et al. I.V. iron saccharate, five years experience [A0301]. Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. October 11-16, 2000.
  19. Richardson D, Bartlett C, Will EJ. Optimizing erythropoietin therapy in hemodialysis patients. Am J Kidney Dis. 2001;38(1):109-117.
  20. Baskin E, Besbas S, Ozdemir S, Topaglu R, Ogzen S, Bakkaloglu A, et al. Effect of intravenous iron saccharate in hemodialyzed children. Abstract from the XXXVI Congress of the European Renal Association/European Dialysis and Transplant Association. September 5-8, 1999, Madrid, Spain.
  21. Morgan H, Gautam M, Geary D. Maintenance intravenous iron therapy in pediatric hemodialysis patients. Pediatr Nephrol. 2001;16:779-783.
  22. Chandler G, Harchowal J, Macdougall IC. Intravenous iron sucrose: establishing a safe dose. Am J Kidney Dis. 2001;38(5):988-991.
  23. 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.
  24. Rothstein M, Carvello A, Charytan C, Collins D. A randomized study to assess the safety and tolerability of 200 and 100 mg of Venofer® administered to hemodialysis patients. Data on file. American Regent, Inc., Shirley, NY [IVEN01015].
  25. McKane W, Green C, Farrington K. Porphyria cutanea tarda precipitated by intravenous iron in a hemodialysis patient. Nephrol Dial Transplant. 2001:1936-1938.
  26. Tarif N, Mitwalli AH, Al-Wakeel JS, Aisha HA, Memon A, Sulaimani F, et al. Safety of intravenous ferrous saccharate administration in hemodialysis patients. A2136 Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. 2001.
  27. Jamil B, Hussain HH, Nasir H, Kumar H, Naqvi SAJ. Parenteral iron sucrose supplementation in iron repleted hemodialysis patients receiving erythropoietin. A1711 Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. 2001.
  28. Sikole A, Spasovski G, Zafirov D, Polenakovic M. Epoetin omega for the treatment of anemia in maintenance hemodialysis patients. Clin Nephrol. 2002;57:237-245.
  29. Domrongkitchaiporn S, Jirakranont B, Atamasnkul K, Ungkanont A, Bunyaratvej A. Indices of iron status in continuous ambulatory peritoneal dialysis patients. Am J Kidney Dis. 1999;34:29-35.
  30. Richardson D, Bartlett C, Jolly H, Will EJ. Intravenous iron for CAPD populations: proactive or reactive strategies? Nephrol Dial Transplant. 2001;16:115-119.
  31. Prakash S, Walek A, Dimkovic N, Bargman J, Vas S, Oreopolos D. Experience with a large dose (500 mg) of intravenous iron dextran and iron saccharate in peritoneal dialysis patients. Periton Dial Int. 2001;21:290-295.
  32. Scarpioni R, Gandolfi S, Cristinelli L. Long-term endovenous iron sucrose in anemic peritoneal dialysis patients on erythropoietin [rHuEPO] treatment do not increase peritonitis complicances: a 48 month study. A1868 Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. 2001.
  33. Monk AJ, Chandler G, Macdougall IC. Intravenous iron sucrose can be safely administered as a 2 minute bolus injection. Brit Renal Symp. June 2002.
  34. Dittrich E, Schillinger M, Sunder-Plassmann G, Horl WH, Vychytil A. Efficacy of a low dose intravenous iron sucrose regimen in peritoneal dialysis patients. Periton Dial Int. 2002;22:60-66.
  35. Aggarwal HK, Tziviskou E, Bellizzi V, Khandewal M, Moupas L, Bargman JM, et al. Prolonged administration over six hours of large doses of intravenous iron saccharate [500 mg] prevents severe adverse reactions in peritoneal dialysis patients. Periton Dial Int. 2002;22:636-637.
  36. 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.
  37. Silverberg DS, Blum M, Agbaria Z, et al. The quick correction of anemia in predialysis chronic renal failure with intravenous iron alone or in combination with erythropoietin. Clin Nephrol. 2001;55:212-219.
  38. Chandler G, Elston O, Davis CM, Williams K, MacDougall IC. Can higher doses of IV iron be given as a bolus injection? A1366 Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. 2000.
  39. Ursea N, Garneata L. Intravenous iron supplementation for the treatment of anemia in predialysis chronic renal failure patients. Nephrol Dial Transplant. 15:abstract, 2000.
  40. Stoves J, Inglis H, Newstead CG. A randomized study of oral vs. intravenous iron supplementation in patients with progressive renal insufficiency treated with erythropoietin. Nephrol Dial Transplant. 2001;16:967-974.
  41. Aaronson ML, Cornell LD. Tolerability of high dose [500 mg] intravenous iron sucrose in pre-dialysis patients receiving either erythropoietin or darbepoetin. SU-PO841 Abstract from the Annual Meeting and Scientific Exposition of the American Society of Nephrology. 2002.
  42. Fassa L, Campos D. Injectable iron in hypochromic anemias in pregnancy. Rev Ginecol Obstet. 1970;127:402-406.
  43. Chamate E. Treatment of iron deficiency in pregnancy and in the immediate puerperium, and of other ferropenic conditions with saccharated iron administered intravenously in fractionated doses. XIV Internat Cong Hemat. San Paolo Brazil, 1972.
  44. Al-Momen AK, Al-Meshari A, Al-Nuaim L, Saddique A, Abotalib Z, Khashogji T, et al. Intravenous iron sucrose in the treatment of iron deficiency anemia during pregnancy. Europ J Obstet Gynecol Reprod Biol. 1996;69:121-124.
  45. Lebrecht A, Haberlin F, Eberhard J. Postpartum anemia: Intravenous iron supplementation renders therapy with r-HuEPO redundant. Geburtsh u Frauenheilk. 1995;55:167-170.
  46. Zimmerman R, Breymann C, Richter C, Huch R, Huch A. r-HuEPO treatment of postpartum anemia. J Perinat Med. 1995;23:111-117.
  47. Breymann C, Major A, Richter C, Huch R, Huch A. Recombinant human erythropoietin and parenteral iron in the treatment of pregnancy anemia: a pilot study. J Perinat Med. 1995;23:89-98.
  48. Polatti F, Mandelli B. Treatment with intravenous Fe of hypochromic anemia in pregnancy (translation) Trattamento con Fe per via endovenosa dell'ameina ipocromica gravidica. Bollettino della Societa Medico-Chirurgica di Pavia. 1983;97(1-2):13-16.
  49. Gravier A, Descargues G, Marpeau L. How to avoid post-partum transfusions: benefit of intravenous iron supplementation. J Gynecol Obstet Reprod. 1999;28:77-78.
  50. Breymann C, Richter C, Huttner C, Huch R, Huch A. Effectiveness of recombinant erythropoietin and iron sucrose vs. iron therapy only, in patients with post-partum anemia and blunted erythropoiesis. Europ J Clin Invest. 2000;30:154-161.
  51. Krafft A, Breymann C, Huch R, Huch A. Intravenous iron sucrose in two pregnant women with inflammatory bowel disease and severe iron deficiency anemia. Acta Obstet Gynecol Scand. 2000;79:720-722.
  52. Delaporte-Cerceau S, BoulayG, Saint Blanquat L, Simon L, Hamza J. Intravenous iron therapy for correction of severe post-partum anemia. Obstet Anaesthesia meeting abstracts A505 April 2000.
  53. Ahmed K, Sadiq I, Yousef AW. Injectable iron therapy: Intramuscular vs. intravenous therapy. Biomedica. 2000;16:44-47.
  54. Frappier J, Delaporte-Cerceau S, deVaumas C, et al. Prise en charge des anemies severes du post-partum interet du fer saccharose intraveneux. Abstract 41st Congress Nat Anesthes. Reanimat 1999 September 23-26.
  55. Breymann C, Vesca E, Huch R, Huch A. Efficacy and safety of intravenously administered iron sucrose with and without adjuvant recombinant human erythropoietin for the treatment of resistant iron-deficiency anemia during pregnancy. Am J Obstet Gyneco. 2001;184:662-667.
  56. Bayoumeu F, Vial F, Zaccabri A, Aguiles O, Laxenaire MC. Anticorps antipublic et grossese: interet du fer intraveneux pour une autofusion avec cryoconservatiob. Ann Fr Anesth Reanim. 2002;21:27-31.
  57. ChalmanovN. Administration of intravenous iron [Venofer® in postpartum anemia syndrome or "Let's replace a blood transfusion when it's not a life-saver." Akush Ginekol. 2000;39:21-23.
  58. Sifakis S, Angelakis E, Vardaki E, Koumantaki Y, Matalliotakis I, Koumantakis E. Erythropoietin in the treatment of iron deficiency anemia during pregnancy. Gynecol Obstet Invest. 2001;51:150-156.
  59. Meyer MP, Haworth C, Meyer JH, Commerford A. A comparison of oral and intravenous iron supplementation in preterm infants receiving recombinant erythropoietin. J Pediatr. 1996;129:258-263.
  60. Martini A, Ravelli A, Di Fuccia G, Rosti V, Cazzola M, Barosi G. Intravenous iron therapy for severe anemia in systemic-onset juvenile chronic arthritis. Lancet. 1994;344:1052-1054.
  61. Berniére J. Dehullu JP, Gall O, Murat I. Le fer intraveineux dans le traitement des anémies postopératoires dans la chirurgie du rachis de l'enfant et de l'adolescent. Intravenous iron therapy for correction of post-operative anemia following spinal surgery in children. Revue Chir Orthoped. 1998;8:319-322.
  62. Michaud L, Guimber D, Mention K, Neuville H, Froger H, Gottrand F, et al. Tolerance and efficacy of intravenous iron saccharate for iron deficiency anemia in children and adolescents receiving long-term parenteral nutrition. Clin Nutr. 2002;21:403-407.
  63. Pollak A, Hayde M, Hayn M, et al. Effect of intravenous iron supplementation on erythropoiesis in erythropoietin-treated premature infants. Pediatr. 2001;107:78-85.
  64. Surico G, Muggeo P, Muggeo V, et al. Parenteral iron supplementation for the treatment of iron deficiency anemia in children. Ann Hematol. 2002; 81:154-157.
  65. Atherton DJ, Cox J, Hann I. Intravenous iron [III] hydroxide-sucrose complex for anaemia in epidermolysis bullosa. Brit J Dermatol. 1999;140:773.
  66. Delaporte-Cerceau S, Prayssac P, Simon L, Hamza J. Intravenous iron therapy for correction of severe post-operative anemia in children. Ped Anesthes Intensive Care A461, 1-4 April 2000.
  67. Jean N, Fraisse D, Loeb T. Transfusional economy: the interest of iron hydroxide-saccharose in the perioperative stage in pediatrics orthopedia and traumatology. CLSAP, Paris, 1997.
  68. Kapelushnik J, Moser A, Levi JV, Landau D, Pinsk V. Intravenous iron therapy in children. Blood. 2000;96:6b [A3676].
  69. Jasper A, Adams A, Smith PA, Lewis NJA. Successful strategies for improving outcome and reducing costs in anemia management in chronic renal impairment. Annual Dial Conf. February 2001.
  70. Gasché C, Dejaco C, Waldhoer T, Tillinger W, Reinisch W, Fueger GF, et al. Intravenous iron and erythropoietin for anemia associated with Crohn's disease. Ann Intern Med. 1997;126:782-787.
  71. Gasché C, Dejaco C, Reinisch W, Tillinger W, Waldhoer T, Fueger GF, et al. Sequential treatment of anemia in ulcerative colitis with intravenous iron and erythropoietin. Digestion. 1999;60(3):262-267.
  72. Bulvik S, Karalnick S, Leibovitz G, Niven M. Intravenous iron gluconate or iron saccharate for patients with malabsorption or oral intolerance. Abstract from the ISH-ASH Combined Hematology Congress July 4-8, 1998, Amsterdam, The Netherlands. Brit J Haematol. 1998;102(1):40.
  73. Stark P, Luboshitz J, Magen H, Bairey O, Shaklai M. Efficacy and safety of intravenous iron polymaltose (Ferrum Hausmann®) in the treatment of iron deficiency anemia. Blood. 1998;92:A#3079.
  74. Reffitt DM, Doig LA, Meenan J, Powell JJ, Thompson RPH. Sustained improvement in the quality of life of patients with anemia and inflammatory bowel disease given intravenous iron. Gut. 1999;44:A39.
  75. Gasche C, Waldhoer T, Feichtenschlager T, et al. Prediction of response to iron sucrose in inflammatory bowel disease-associated anemia. Am J Gastroenterol. 2001;96:2382-2387.
  76. Mercuriali F, Zanella A, Barosi G, Inghilleri G, Biffi E, Vinci A, et al. Use of erythropoietin to increase the volume of autologous blood donated by orthopedic patients. Transfusion. 1993;33:55-60.
  77. DePree C, Mermillod B, Hoffmeyer P, Beris P. Recombinant human erythropoietin as adjuvant treatment for autologous blood donation in elective surgery with large blood needs [≥5 units]: a randomized study. Transfusion. 1997;37:708-714.
  78. Weisbach V, Skoda P, Rippel R, Lauer G, Glaser A, Zingsem J, et al. Oral or intravenous iron as an adjuvant to autologous blood donation in elective surgery: a randomized controlled study. Transfusion. 1999;39:465-472.
  79. Rohling RG, Zimmerman AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000;9:497-500.
  80. Kipnis E, Deneux C. Utilisation de fer intra-veneux comme alternative a la transfusion homologue en chirurgie orthopedique. Abstract 72. Third Congres Nat. Securite Transfusionnelle Hemovigilance. September 1999.
  81. Olijhoek G, Megens GN, Musto P, Nogarin L, Gassmann-MayerC, Vercammen E, et al. Role of oral versus IV iron supplementation in the erythropoietic response to rHuEPO: a randomized, placebo controlled trial. Transfus Med. 2001;41:957-963.
  82. Walpoth BH, Aregger F, Imboden C, Auckenthaler E, Nydegger U, Carrel T. Safety of preoperative autologous blood donations in cardiac surgery. Infusion Ther. 2002;29:160-162.
  83. Breymann C, Buhner M, Lex B, Tulusan A. Recombinantes erythropoietin [40 000 E] und eisensaccharatkomplex zur perioperativen anwendung in der gynekologie. Personal communication. February 2003.
  84. Silverberg DS, Wexler D, Blum M, Keren G, Sheps D, et al. The use of subcutaneous erythropoietin and intravenous iron for the treatment of the anemia of severe, resistant congestive heart failure improves cardiac and renal function and functional cardiac class, and markedly reduces hospitalizations. J Am Coll Cardiol. 2000;35:1737-1744.
  85. Silverberg DS, Wexler D, Sheps D, et al. The effect of correction of mild anemia in severe, resistant congestive heart failure using subcutaneous erythropoietin and intravenous iron: a randomized controlled study. J Am Coll Cardiol. 2001;37:1775-1780.
  86. Höchli P, Wagenhäuser FJ, Fehr J. Repeated continuous administration of low doses of intravenous iron in anemic patients with active rheumatoid arthritis. Eur J Hematol. 1993;51:54-55.
  87. Kaltwasser JP, Kessler U, Gottschalk R, Stucki G, Moeller B. Effect of recombinant human erythropoietin and intravenous iron on anemiaand disease activity in rheumatoid arthritis. J Rheumatol. 2001;28:2430-2436.
  88. Montecucco C, Caporali R, Invernizzi R. Iron status in Still's disease. Lancet. 1995;345:58-59.
  89. 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.
  90. Blaustein DA et al. Intolerance to 1 gram iron sucrose infusions in chronic kidney disease patients. ASN 2003, San Diego Ca.
  91. Blaustein DA et al. The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney diseases. Kidney Int. 2003;64(suppl 87): s72-s77.
  92. Charytan, C., Qunibi, W., Bailie, G. 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;100: c55-c62.
  93. Fesyuk AF et al. Use of Venofer for correction of iron deficiency in patients with programmed haemodialysis. Nephrol Terapevticheskiy. 2003;8:59-61.
  94. Hollands et al. Safety and efficacy of high dose iron sucrose infusion in hospitalized CKD patients. ASN 2003, San Diego Ca.
  95. Kosmadakis N et al. Perioperative erythropoietin administration in patients with gastrointestinal tract cancer. Ann of Surg. 2003;237(3):417-421.
  96. Moniem et al. Tolerability and efficacy of parenteral iron therapy in haemodialysis patients. Abstract ASN 2003, San Diego Ca.
  97. Seronie-Vivien S et al Epoetin alfa and iron sucrose to treat severe anemia in a patient with chronic radiation enteropathy. Med Oncol. 2003;20(3):301-306.
  98. Khalid AM et al. A prospective randomized open-label study comparing the efficacy and safety of intraperitoneal iron versus intravenous iron in peritoneal dialysis patients. Am J Nephrol. 2004;24:61-146.
  99. Bodemar G. Treatent of anaemia in inflammatory bowel disease with iron sucrose. Scand J of Gastroenterol. 2004;39(5):454-458.
  100. Agarwal R et al. Oxidative stress and renal injury with intravenous iron in patients with chronic kidney disease. Kidney Int. 2004;65:2279-2289.
  101. Monnerat et al. Early administration of haemaglobin-adapted doses of erythropoietin with intravenous iron for the prevention of chemotherapy induced anaemia. Eur J of Cancer Supplements. 2003;1(5):s284.
  102. Cavdar C et al. The effect of intravenous iron treatment on oxidant stress and erythrocyte deformability in hemodialysis patients. Scand J of Urology and Nephrol. 2003;37:77-82.
  103. Oliviera A et al. Improvement of preoperative autologous donation (PAD) with recombinant human erythropoietin and intravenous iron. Abstract from NATA 4th Annual Symposium 2003, London UK.
  104. Sharbova-Slavova M et al. Treatment of perioperative anemia with erythropoietin beta and monitoring the therapeutic effect. Abstract from NATA 4th Annual Symposium 2003, London UK.
  105. Cuenca J et al. Parenteral iron useful in the management of trochanteric hip fracture. Abstract from NATA 4th Annual Symposium 2003, London UK.
  106. Olivera A et al. Intravenous iron in different pathologies. Abstract from NATA 4th Annual Symposium 2003, London UK.
  107. Wali A et al. Comparative study- Efficacy, safety and compliance of intravenous iron sucrose and intramuscular iron sorbitol in iron deficiency anaemia of pregnancy. J Pakistan Med Assoc. 2002;52:392-395.
  108. Tabassum R et al. Place of intravenous iron sucrose for the treatment of iron deficiency anemias during pregnancy. Med Channel. 9(1):55-56.
  109. Chuang CL et al Early prediction of response to intravenous iron supplementation by reticulocyte hemoglobin content and high-flourescence reticulocyte count in hemodialysis. Nephrol Dial Transplant. 2003;18:370-377.
  110. Furuland H et al. A randomized controlled trial of hemoglobin normalization with epoetin alfa in predialysis and dialysis patients. Nephrol Dial Transplant. 2003;18:353-361.
  111. Schroder et al. A study for the evaluation of safety and tolerability of intravenous high-dose iron sucrose in patients with iron deficiency anemia due to gastrointestinal bleeding. Z Gastroenterol. 2004;42:663-667.
  112. Borawski et al. Endothelial injury markers with high-dose intravenous iron therapy in renal failure. Clin Appl Thrombosis/Hemostatis. 2004;10(4):403-406.
  113. Tiranathangul K et al. Oxidative stress from rapid vs. slow intravenous iron replacement in haemodialysis patients. Nephrol. 2004;9:217-222.
  114. Abello V et al. Intravenous saccharate iron for the treatment of ferropenic anemia in adults that cannot tolerate oral iron intake. Acta Medica Colombiana. 2004;29(4):322-327.
  115. Schwenk MH, Blaustein DA et al. Rapid high-dose intravenous iron sucrose therapy in 2 Jehovah's Witness patients with severe anaemia, iron deficiency and chronic kidney disease. Clin Nephrol. 2004;62(2):116-120.
  116. Sengoelge G et al Dose-dependent effect of parenteral iron therapy on bleomycin-detectable iron in immune apheresis patients. Kidney Int. 2004;66:295-302.
  117. Pyatibratov VB et al. Human recombinant erythropoietin and iron therapy in the treatment of patients with chronic renal failure at chronic haemodialysis. Voprosy gematologii/onkologii/immunopatologii v pediatrii. 2004;3(1):74-77.
  118. Cuenca J et al. Patients with pertrochanteric hip fracture may benefit from preoperative intravenous iron therapy: a pilot study. Transfusion. 2004;44:1447-1452.
  119. Cuenca Espierrez et al. Safety and usefulness of parenteral iron in the management of anaemia due to hip fracture in the elderly. Med Clin (Barc). 2004;123(8):281-285.
  120. Abdel-Razeq H et al. Parenteral ferric hydroxide saccharate therapy for iron deficiency anemia: safety and efficacy. Blood. 2004;104(11): abs #3681.
  121. Erichsen K et al. Oral versus intravenous iron therapy in patients with inflammatory bowel disease. Gut. 2004;53(suppl V):A220.
  122. Biesenbach G et al. Erythropoietin requirement in patients with type 2 diabetes mellitus on maintenance haemodialysis therapy. Wein Klin Wochenschr. 2004;116(24):844-848.
  123. 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.
  124. Singh H, Reed J, Noble S, Cangiano J, Van Wyck DB for the United States Iron Sucrose (Venofer® )Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006;1:475-482.
  125. Charytan C, Schwenk M, Al-Saloum M, Spinowitz BS. Safety of Iron Sucrose in Hemodialysis Patients Intolerant to other parenteral iron products. Nephron Clin Pract. 2003;96:c63-c66.
  126. NKF-KDOQI Clinical Practice Guidelines for the Treatment of Anemia of Chronic Renal Failure. New York, National Kidney Foundation, 2000.





 
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.