Sodium Ferric Gluconate

Class: Iron Preparations
Molecular Formula: C₁₂H₂₂FeO₁₄
CAS Number: 299-29-6
Brands: Ferrlecit

Medically reviewed by Drugs.com on Oct 25, 2021. Written by ASHP.

Introduction

Hematinic agent; stable macromolecular complex composed of ferric oxide hydrate directly bonded to sucrose and chelated with gluconate.

Uses for Sodium Ferric Gluconate

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Treatment of iron deficiency anemia in adult and pediatric hemodialysis patients receiving epoetin alfa therapy.

In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron in increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA) (e.g., epoetin alfa); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route of iron administration is preferred in such patients.

Limited data suggest that iron sucrose and sodium ferric gluconate injections may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) compared with iron dextran injection.

Safety and efficacy not established for the prevention and/or treatment of iron deficiency anemia not associated with CKD (e.g., HIV- or cancer-related anemia).

Sodium Ferric Gluconate Dosage and Administration

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer (diluted) by slow IV infusion or (undiluted) by slow IV injection.

Dilution

For IV infusion, dilute recommended adult or pediatric dosage in 100 or 25 mL of 0.9% sodium chloride, respectively.

Use immediately after dilution.

Rate of Administration

IV infusion: slowly (e.g., over 1 hour).

IV injection (adults): slowly, up to 12.5 mg/minute at the end of dialysis.

Dosage

Dosage is expressed in terms of mg of elemental iron. Sodium ferric gluconate injection contains the equivalent of 12.5 mg of elemental iron per mL.

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

1.5 mg/kg (up to 125 mg/dose) administered at or during hemodialysis for 8 sequential dialysis sessions.

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

125 mg administered at sequential dialysis sessions or during the dialysis session itself. Most patients will require a minimum cumulative dose of 1 g of elemental iron, administered over 8 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response.

Monitor iron indices (i.e., transferrin saturation [TSAT], serum ferritin concentrations) periodically, and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. Once patients achieve TSAT levels ≥20% or serum ferritin concentrations ≥100 ng/mL, continue IV iron therapy at the lowest dose ne...