Ferrlecit Sodium Ferric Gluconate Sucrose Injection 62.5 mg Elemental Iron 5 mL x 10/Box (RX)

Ferrlecit (Sodium Ferric Gluconate Complex in Sucrose) Injection, 62.5 mg/5 mL Ferrlecit is an intravenous iron‐replacement preparation (brand of sodium ferric gluconate complex). It is a colloidal carbohydrate‐stabilized iron solution; each 5 mL single‐dose vial delivers 62.5 mg elemental iron (12.5 mg/mL). In this formulation, ferric iron (Fe³⁺) is bound as a sodium ferric gluconate complex in a 20% sucrose solution (pH ~7.7–9.7). The solution has a characteristic deep red color due to ferric oxide linkages. Chemically, Ferrlecit is a high‐molecular‐weight (~300–440 kDa) iron‐gluconate complex. It provides a controlled release of iron to the body and contains benzyl alcohol (as a preservative), which precludes use in neonates. As an iron preparation, Ferrlecit’s purpose is to replete total-body iron stores when oral iron is inadequate. Mechanism of Action: The ferric iron in Ferrlecit is taken up by the reticuloendothelial system and slowly released to bind transferrin. Once bound to transferrin, the iron is delivered to the bone marrow for hemoglobin synthesis and to other tissues (including myoglobin and iron‐dependent enzymes). Iron is critical for hemoglobin to carry oxygen and for enzymatic reactions (e.g. ribonucleotide reductase for DNA synthesis). Administering Ferrlecit replenishes iron needed for red blood cell production in iron‐deficient patients. The carbohydrate (gluconate) and sucrose stabilize the ferric iron in solution, minimizing free “unbound” iron and reducing oxidative toxicity. Clinical Uses: Ferrlecit is FDA-approved for iron deficiency anemia in chronic kidney disease (CKD) patients on hemodialysis who are receiving erythropoiesis-stimulating agents. It is indicated for adults and for pediatric patients ≥6 years old with CKD on dialysis. By providing intravenous iron, Ferrlecit helps achieve adequate hemoglobin levels in patients who lose iron in dialysis and who do not absorb sufficient iron orally. In practice, it is often used when oral iron fails or cannot be tolerated. (Note: In adults without CKD, other IV iron products may be preferred; Ferrlecit’s labeled use is specific to dialysis patients on epoetin therapy. Dosage and Administration: Ferrlecit is administered intravenously by slow injection or infusion under medical supervision. Important dosing and preparation points include: Dose and Concentration: Each vial contains 62.5 mg elemental iron in 5 mL (12.5 mg/mL). Because the usual adult dose is 125 mg, two vials (10 mL) are typically used per dialysis session. Adult dosing: The recommended adult dose for repletion is usually 125 mg elemental iron per session (often given as 10 mL). This can be administered either as: Intravenous infusion: 125 mg diluted in 100 mL of normal saline (0.9% NaCl) infused over ~60 minutes. Slow IV push: 125 mg undiluted (in 10 mL) given slowly (no faster than 12.5 mg/min). Pediatric dosing (≥6 years): Typically 1.5 mg/kg (0.12 mL/kg) elemental iron per session, diluted in 25 mL saline over 1 hour. Administration precautions: Ferrlecit vials are single-dose and contain benzyl alcohol preservative. Do not mix Ferrlecit with any other drugs or IV solutions (including dextrose, calcium solutions, or parenteral nutrition). The only compatible diluent is 0.9% sodium chloride. Inspect the solution before use; it should be a clear, dark brown liquid without particulate. If diluted, use the solution immediately. Infusion setup: Use dedicated IV line with normal saline; flush line before and after administration to avoid venous irritation. Do not administer Ferrlecit by any route other than intravenous. Total treatment course: Iron repletion often requires multiple doses. Clinically, a full replacement course may total ~1000 mg of elemental iron (e.g. 8 doses of 125 mg) administered over several dialysis sessions. Doses above 125 mg/session are not recommended due to increased risk of reactions. Repeat treatment only if iron deficiency recurs. Adverse Reactions (Side Effects): Common reactions include gastrointestinal effects and injection-related symptoms. In clinical studies, ≥10% of adults reported: nausea, vomiting, diarrhea, injection-site reaction (pain, swelling), hypotension, muscle cramps (leg cramps), hypertension, dizziness, dyspnea (shortness of breath), chest pain, and leg cramps. In children (6–15 years), the most frequent (≥10%) were hypotension, headache, hypertension, tachycardia, and vomiting. Generally, reactions are mild-to-moderate; gastrointestinal symptoms and injection-site discomfort were common. Serious Reactions and Precautions: Hypersensitivity/Anaphylaxis: Although rare, anaphylactic-type allergic reactions can occur (some life-threatening or fatal). These may manifest as chest pain, lightheadedness, rash, bronchospasm, or shock. Monitoring: Patients must be monitored during and for at least 30 minutes after each dose. Treat immediately if an allergic reaction occurs (epinephrine, IV steroids, and supportive care at the ready). Do not administer Ferrlecit if severe allergy to iron–carbohydrate complexes is known. Hypotension: Acute drops in blood pressure can happen during or shortly after infusion. Monitor blood pressure and symptoms throughout infusion. If hypotension occurs, slow or stop the infusion until stabilized. Iron Overload: Avoid administering Ferrlecit when iron stores are already high. Regularly check hematologic indices (hemoglobin, ferritin, transferrin saturation). Contraindication: Do not give Ferrlecit to patients with existing iron overload. Overload may exacerbate organ damage. Benzyl Alcohol Toxicity: Ferrlecit contains benzyl alcohol (preservative). Premature or low-birth-weight infants are at risk of “gasping syndrome” if exposed to benzyl alcohol . Thus, Ferrlecit should not be used in neonates or infants, and caution is advised in pregnant patients. Pregnancy/Lactation: Use in pregnancy only if clearly needed (“high risk” category). Hypersensitivity reactions can affect the fetus; benzyl alcohol is hazardous to the fetus. Breastfeeding is not recommended during treatment. Other Contraindications: Do not use in patients with known hypersensitivity to sodium ferric gluconate or any inactive ingredients. Common Side Effects Summary: These may include nausea, vomiting, diarrhea, headache, muscle cramps, dizziness, rash, pruritus, hypertension or hypotension, cough, and injection-site reactions. Most resolve within hours and are managed supportively. If severe symptoms arise, discontinue the dose and provide appropriate care. Key Points for Practitioners: Ferrlecit is a targeted IV iron therapy for dialysis patients. It should always be administered slowly with resuscitation measures available. Monitor patients’ vital signs and iron indices. Ensure the correct dose (62.5 mg/vial) and follow dilution guidelines (normal saline only). Always inform patients about possible allergic reactions and instruct them to report any unusual symptoms immediately.