title: Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration.
abstract: BACKGROUND
  Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients.
  
  
  METHODS
  The authors reviewed the safety and tolerability of higher-dose SFGC infusions (> or =250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of > or =250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min.
  
  
  RESULTS
  Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC.
  
  
  CONCLUSIONS
  Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses.
authors.affiliation: Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA. vaughnwf@earthlink.net
authors.forename: Vaughn W
authors.initials: VW
authors.lastname: Folkert
authors.forename: Beckie
authors.initials: B
authors.lastname: Michael
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Coyne
authors.forename: Naomi
authors.initials: N
authors.lastname: Dahl
authors.forename: Pamela
authors.initials: P
authors.lastname: Myirski
authors.forename: David G
authors.initials: DG
authors.lastname: Warnock
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000188:drug therapy / Q000209:etiology; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000379:methods; D011159:Population Surveillance; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; C035552:ferric gluconate