The comparative safety of intravenous iron dextran, iron saccharate and sodium ferric gluconate
Sodium ferric gluconate
and iron sucrose are covalently bound irons and have adverse reactions primarily due to the release of free iron.
Sodium ferric gluconate
causes oxidative stress but not acute renal injury in patients with chronic kidney disease: A pilot study.
To comply with the ESA label and improve treatment of poor responders to ESA, the team followed the example of the DRIVE study and treated iron-restricted erythropoiesis in patients with serum ferritin values up to 1,200 ng/mL, using 1 g of iron (up to 125 mg of sodium ferric gluconate
given per session for a total of 8 sessions) (Coyne et al.
After screening, study participants were randomized to receive either IV iron (1 g of sodium ferric gluconate
administered as 125 mg doses over 8 consecutive hemodialysis sessions) or no IV iron (control).
Study results demonstrated that 1 gram of sodium ferric gluconate
administered during 8 consecutive hemodialysis sessions is effective in improving anemia in this patient type (Coyne et al.
Nurses were informed to initially address anemia by following a simple IV iron repletion protocol, consisting of sodium ferric gluconate
125 mg delivered at 8 consecutive dialysis sessions, when TSAT levels were less than 20% and serum ferritin levels were less than 100 ng/mL (parameters established in the 2001 KDOQI guidelines, which have been updated in the 2006 version).
Since 2002, the facility has been using an IV iron maintenance regimen of sodium ferric gluconate
at doses of 31.
Because none of the patients received heparin during their treatment, sodium ferric gluconate
was placed in the syringe and administered during the dialysis treatment at home.
Because the facility was changing interventions, the management team also decided it was important to provide educational services about sodium ferric gluconate
and revise their IV iron protocol.
The first step was to identify a single product for IV iron replacement therapy; during this time only iron dextran and sodium ferric gluconate
Safety studies have shown that the rate of serious adverse reactions associated with sodium ferric gluconate
is about 4 in 10,000 patients--a rate not significantly different from that found with placebo (Michael, Coyne & Fishbane, 2002).
The largest prospective safety analysis conducted to date in HD patients (N=2493) found no difference between sodium ferric gluconate
and placebo in the rate of serious adverse events (0.
There are four IV iron supplements available in the United States: two dextrans (INFeD[R], Watson Pharmaceuticals, Corona, Calif; Dexferrum[R], American Regent Laboratories, Inc, Shirley, NY) and two nondextrans (iron sucrose [Venofer[R], American Regent Laboratories, Inc, Shirley, NY] sodium ferric gluconate
[Ferrlecit[R], R&D Laboratories, Marina Del Rey, Calif]).
Several different IV iron preparations are available in the United States for the treatment of iron deficiency in hemodialysis patients, including iron dextran, iron sucrose, and sodium ferric gluconate