Chronic use of sodium ferric gluconate complex in hemodialysis patients: Safety of higher-dose (≥250 mg) administration

Vaughn W. Folkert, Beckie Michael, Rajiv Agarwal, Daniel W. Coyne, Naomi Dahl, Pamela Myirski, David G. Warnock

Research output: Contribution to journalArticle

37 Citations (Scopus)

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 (≥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 ≥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. Conclusion: Administration of 250 mg SFGC over I 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.

Original languageEnglish (US)
Pages (from-to)651-657
Number of pages7
JournalAmerican Journal of Kidney Diseases
Volume41
Issue number3
DOIs
StatePublished - Mar 1 2003

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Patient Safety
Renal Dialysis
Iron
Safety
ferric gluconate
gluconic acid
Iron-Deficiency Anemias
Peritoneal Dialysis
United States Food and Drug Administration
Therapeutics
Pruritus
Dextrans
Chronic Renal Insufficiency
Anemia
Maintenance

Keywords

  • Anemia
  • Hemodialysis (HD)
  • Higher doses
  • Intravenous iron
  • Iron
  • Iron deficiency
  • Iron sucrose
  • Safety
  • Sodium ferric gluconate

ASJC Scopus subject areas

  • Nephrology

Cite this

Chronic use of sodium ferric gluconate complex in hemodialysis patients : Safety of higher-dose (≥250 mg) administration. / Folkert, Vaughn W.; Michael, Beckie; Agarwal, Rajiv; Coyne, Daniel W.; Dahl, Naomi; Myirski, Pamela; Warnock, David G.

In: American Journal of Kidney Diseases, Vol. 41, No. 3, 01.03.2003, p. 651-657.

Research output: Contribution to journalArticle

Folkert, Vaughn W. ; Michael, Beckie ; Agarwal, Rajiv ; Coyne, Daniel W. ; Dahl, Naomi ; Myirski, Pamela ; Warnock, David G. / Chronic use of sodium ferric gluconate complex in hemodialysis patients : Safety of higher-dose (≥250 mg) administration. In: American Journal of Kidney Diseases. 2003 ; Vol. 41, No. 3. pp. 651-657.
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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 (≥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 ≥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. Conclusion: Administration of 250 mg SFGC over I 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.",
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T1 - Chronic use of sodium ferric gluconate complex in hemodialysis patients

T2 - Safety of higher-dose (≥250 mg) administration

AU - Folkert, Vaughn W.

AU - Michael, Beckie

AU - Agarwal, Rajiv

AU - Coyne, Daniel W.

AU - Dahl, Naomi

AU - Myirski, Pamela

AU - Warnock, David G.

PY - 2003/3/1

Y1 - 2003/3/1

N2 - 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 (≥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 ≥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. Conclusion: Administration of 250 mg SFGC over I 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.

AB - 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 (≥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 ≥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. Conclusion: Administration of 250 mg SFGC over I 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.

KW - Anemia

KW - Hemodialysis (HD)

KW - Higher doses

KW - Intravenous iron

KW - Iron

KW - Iron deficiency

KW - Iron sucrose

KW - Safety

KW - Sodium ferric gluconate

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