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 necessary to maintain target hematocrit/hemoglobin levels and iron stores within acceptable limits.

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Maximum dose: 125 mg per session.

Contraindications

• Known hypersensitivity to sodium ferric gluconate or any ingredient in the formulation.

• Evidence of iron overload.

• Anemias not associated with iron deficiency.

Warnings/Precautions

Iron Overload

Not easily eliminated from the body (not dialyzable) and accumulation can be toxic; avoid unwarranted therapy.

Excess storage of iron may possibly result in a syndrome similar to hemosiderosis, particularly in patients whose anemia is not attributable to iron deficiency (e.g. those with hemoglobinopathies or other refractory anemias that might be erroneously diagnosed as iron deficiency anemia).

Hypotension

Possible hypotension accompanied by flushing, lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin. Such reactions are not associated with sensitivity and usually resolve within 1–2 hours. May require volume expansion if symptomatic.

Sensitivity Reactions

Hypersensitivity Reactions

Potentially fatal sensitivity (e.g. anaphylactic or anaphylactoid) reactions possible; use with caution, particularly in patients with a history of allergic reactions to iron dextran.

If serious anaphylactoid reactions occur, institute appropriate resuscitative measures.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether sodium ferric gluconate is distributed into milk; use with caution in nursing women.

Pediatric Use

Safety and efficacy not established in children <6 years of age.

Contains benzyl alcohol; not recommended for use in neonates.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.

Titrate dosage carefully.

Common Adverse Effects

Hypotension, nausea, vomiting and/or diarrhea, pain, hypertension, allergic reaction, chest pain, pruritus, back pain.

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 necessary to maintain target hematocrit/hemoglobin levels and iron stores within acceptable limits.

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Maximum dose: 125 mg per session.

No formal drug interaction studies to date.

Specific Drugs