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Sodium Ferric Gluconate

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

Medically reviewed on Nov 5, 2018

Introduction

Hematinic agent;1 8 28 stable macromolecular complex composed of ferric oxide hydrate directly bonded to sucrose and chelated with gluconate.1 2 3

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.1 15

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.5

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.2 3 100 101

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).44 97

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.1 2 19

Dilution

For IV infusion, dilute recommended adult or pediatric dosage in 100 or 25 mL of 0.9% sodium chloride, respectively.1

Use immediately after dilution.1

Rate of Administration

IV infusion: slowly (e.g., over 1 hour).1 3

IV injection (adults): slowly, up to 12.5 mg/minute1 2 at the end of dialysis.6 7 16 21

Dosage

Dosage is expressed in terms of mg of elemental iron.1 Sodium ferric gluconate injection contains the equivalent of 12.5 mg of elemental iron per mL.1

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.a

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.1 3 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.1 3

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.5 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.1

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy
IV

Maximum dose: 125 mg per session.a

Cautions for Sodium Ferric Gluconate

Contraindications

  • Known hypersensitivity to sodium ferric gluconate or any ingredient in the formulation.1

  • Evidence of iron overload.1

  • Anemias not associated with iron deficiency.1

Warnings/Precautions

Iron Overload

Not easily eliminated from the body (not dialyzable) and accumulation can be toxic; avoid unwarranted therapy.1

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).1 8

Hypotension

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

If serious anaphylactoid reactions occur, institute appropriate resuscitative measures.1

Specific Populations

Pregnancy

Category B.1

Lactation

Not known whether sodium ferric gluconate is distributed into milk; use with caution in nursing women.1

Pediatric Use

Safety and efficacy not established in children <6 years of age.1

Contains benzyl alcohol; not recommended for use in neonates.1

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.1

Titrate dosage carefully.1

Common Adverse Effects

Hypotension, nausea, vomiting and/or diarrhea, pain, hypertension, allergic reaction, chest pain, pruritus, back pain.1

Interactions for Sodium Ferric Gluconate

No formal drug interaction studies to date.1

Specific Drugs

Drug

Interaction

Comment

ACE inhibitors

Possible potentiation of adverse effects (e.g., hypotension, sensitivity reactions) associated with IV iron therapy14

Use concomitantly with caution14

Iron, oral

Reduced absorption of oral iron1

Concomitant use not recommended1

Sodium Ferric Gluconate Pharmacokinetics

Distribution

Extent

Ferric iron in plasma combines with transferrin and is carried to the bone marrow and incorporated into hemoglobin.9 27 29 30 31

Elimination

Half-life

Following IV administration, terminal elimination half-life of drug-bound iron was approximately 1 hour in healthy iron-deficient adults.1

Following IV administration of 1.5 or 3 mg/kg, terminal elimination half-life was 2 or 2.5 hours, respectively, in iron-deficient pediatric patients.a

Special Populations

In vitro, <1% of the iron species in a single dose was removed during hemodialysis periods of up to 270 minutes using membranes with pore sizes corresponding to 12,000–14,000 daltons.99

Stability

Storage

Parenteral

Injection

20–25°C (may be exposed to temperatures ranging from 15–30°C).1 Do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Sodium ferric gluconate should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.1

Solution Compatibility1

Compatible

Sodium Chloride 0.9%

Actions

  • Replenishes and maintains total body content of iron and has pharmacologic actions similar to those of iron dextran.1 8 28

  • Unlike iron dextran, sodium ferric gluconate is free of ferrous ion and dextran polysaccharides and may be associated with fewer sensitivity reactions.1 2 3 10

Advice to Patients

  • Risk of hypersensitivity (e.g., anaphylactoid) reactions.1

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Sodium Ferric Gluconate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

equivalent to 12.5 mg of elemental iron per mL

Ferrlecit

Sanofi-Aventis

AHFS DI Essentials. © Copyright 2018, Selected Revisions November 4, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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3. Nissenson AR, Lindsay RM, Swan S et al. Sodium ferric gluconate in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis. 1999; 33(3):471-82. http://www.ncbi.nlm.nih.gov/pubmed/10070911?dopt=AbstractPlus

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