Is Ferrlecit (sodium ferric gluconate) a type of intravenous (IV) iron?

Ferrlecit (Sodium Ferric Gluconate) is an Intravenous Iron Preparation

Yes, Ferrlecit (sodium ferric gluconate complex in sucrose) is a type of intravenous (IV) iron preparation used primarily for treating iron deficiency anemia in patients with chronic kidney disease. 1

Composition and Formulation

Ferrlecit is a stable macromolecular complex with the following characteristics:

• Contains 62.5 mg of elemental iron per 5 mL single-dose vial (12.5 mg/mL) 1
• Formulated as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution 1
• Contains approximately 20% sucrose and 9 mg/mL of benzyl alcohol as an inactive ingredient 1
• Has a deep red color indicative of ferric oxide linkages 1
• Appears as a clear, dark brown liquid in colorless glass vials 1

FDA-Approved Indications

Ferrlecit is specifically indicated for:

• Treatment of iron deficiency anemia in adult patients with chronic kidney disease receiving hemodialysis who are on supplemental epoetin therapy 1
• Treatment of iron deficiency anemia in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are on supplemental epoetin therapy 1

Administration Methods

Ferrlecit can be administered in two ways:

1. Diluted administration: Diluted in 100 mL of 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session 1
2. Undiluted administration: Administered undiluted as a slow intravenous injection at a rate of up to 12.5 mg/min per dialysis session 1

Dosing

For adults:

• The recommended dose is 10 mL (125 mg of elemental iron) per dialysis session 1
• For repletion treatment, most patients require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions 1

For pediatric patients:

• The recommended dose is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride 1
• Maximum dose should not exceed 125 mg per dose 1

Safety Profile

Ferrlecit has several important safety considerations:

• Serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported 1
• Reactions to iron gluconate are generally less common and of lesser severity than those to iron dextran 2
• No reported deaths due to IV use of iron gluconate 2
• Patients should be monitored for signs of hypersensitivity during and for at least 30 minutes after administration 1
• Individual doses exceeding 125 mg may be associated with higher incidence and/or severity of adverse events 1

Comparison to Other IV Iron Preparations

Ferrlecit differs from other IV iron preparations:

• Unlike iron dextran, patients who react to iron dextran generally do not react to iron gluconate 2
• Ferrlecit typically requires multiple administrations to deliver equivalent iron doses compared to newer formulations like ferric derisomaltose (Monoferric) which can deliver 1000 mg in a single infusion 3
• Ferrlecit has been shown to be stable when undiluted for ≥2 days at room temperature and ≥7 days under refrigerated conditions 4

Clinical Considerations

When using Ferrlecit:

• Monitor for hypotension, flushing, loin pain, and upper gastric pain, which may rarely occur 2
• Do not administer to patients with iron overload 1
• The drug is not dialyzable 1
• Ferrlecit has been shown to be effective in improving hemoglobin and hematocrit levels in iron-deficient hemodialysis patients 5

Ferrlecit represents an important therapeutic option for managing iron deficiency anemia in chronic kidney disease patients on hemodialysis, with a well-established safety and efficacy profile.