Sodium Ferric Gluconate
Class: Iron Preparations
Molecular Formula: C12H22FeO14
CAS Number: 299-29-6
Uses for Sodium Ferric Gluconate
Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy
National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines recommend regular use of IV iron to prevent functional (and absolute) iron deficiency and improve erythropoiesis in most hemodialysis patients receiving epoetin alfa therapy.5
Sodium Ferric Gluconate Dosage and Administration
Goal of iron therapy in patients with CFR is to achieve and maintain a transferrin saturation (TSAT) of at least 20% and a serum ferritin concentration of at least 100 ng/mL.5
Monitor maintenance iron status by measuring TSAT and serum ferritin concentration every 3 months.5
For solution and drug compatibility information, see Compatibility under Stability.
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
Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy
1.5 mg/kg (up to 125 mg/dose) administered at or during hemodialysis for 8 sequential dialysis sessions.a
Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy
125 mg administered at sequential dialysis sessions or during the dialysis session itself.1 3 Most patients will require a minimum cumulative dose of 1000 mg of elemental iron, administered over 8 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response.1 3 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 Weekly maintenance dosage of 25–100 mg of elemental iron for 10 weeks may be appropriate in hemodialysis patients once optimal hematocrit/hemoglobin stores are attained.5
If TSAT ≥50% or serum ferritin concentrations ≥800 ng/mL, withhold iron therapy for up to 3 months.5 IV iron therapy may be resumed at a dosage that is 33-50% of the previous iron dosage when TSAT and serum ferritin concentration have decreased to <50% and <800 ng/mL, respectively.5
Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy
Maximum dose: 125 mg per session.a
Cautions for Sodium Ferric Gluconate
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
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
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
Excessive dosing may lead to iron accumulation and hemosiderosis. Manifestations of acute toxicity in animals included decreased activity, staggering ataxia, increased respiratory rate, tremor and seizures. Not dialyzable.
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.
Not known whether sodium ferric gluconate is distributed into milk; use with caution in nursing women.1
Safety and efficacy not established in children <6 years of age.1
Contains benzyl alcohol; not recommended for use in neonates.1
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
Possible potentiation of adverse effects (e.g., hypotension, sensitivity reactions) associated with IV iron therapy14
Use concomitantly with caution14
Reduced absorption of oral iron1
Concomitant use not recommended1
Sodium Ferric Gluconate Pharmacokinetics
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 was 2 or 2.5 hours, respectively, in iron-deficient pediatric patients.a
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
For information on systemic interactions resulting from concomitant use, see Interactions.
Sodium ferric gluconate should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.1
Sodium Chloride 0.9%
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.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Injection, for IV use
equivalent to iron 12.5 mg/mL
Ferrlecit (with benzyl alcohol 0.9% and sucrose 20% w/v)
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions July 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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