Sod Ferric Gluconate Complex (sodium ferric gluconate complex in sucrose)

The dosage of sodium ferric gluconate 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.

For the treatment of iron deficiency in adults undergoing chronic hemodialysis who are receiving supplemental epoetin alfa therapy, the recommended dosage of sodium ferric gluconate is 125 mg administered by IV infusion over 1 hour. Most adults 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.

In patients with chronic kidney disease who are receiving supplemental therapy with an erythropoiesis-stimulating agent (ESA), sufficient iron should be administered to maintain selected indices of iron therapy (i.e., transferrin saturation (TSAT) and serum ferritin concentrations) at target levels; periodic monitoring of these iron indices is recommended, and the results should be used (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. Once patients achieve TSAT levels of 20% or greater or serum ferritin concentrations of 100 ng/mL or greater, IV iron therapy with sodium ferric gluconate or other IV iron preparations should be continued at the lowest dose necessary to maintain target hematocrit/hemoglobin levels and iron stores within acceptable limits.

For the treatment of iron deficiency in children undergoing chronic hemodialysis who are receiving supplemental epoetin alfa therapy, the recommended dosage of sodium ferric gluconate is 1.5 mg/kg (up to 125 mg/dose) diluted in 25 mL 0.9% sodium chloride and administered by IV infusion over 1 hour during 8 sequential dialysis sessions.

Sodium ferric gluconate is administered by IV infusion. The drug should be diluted in 0.9% sodium chloride injection and administered by slow IV infusion (e.g., over 1 hour). Sodium ferric gluconate also may be administered undiluted by slow IV injection at a rate of up to 12.5 mg/minute at the end of dialysis. Sodium ferric gluconate should be administered immediately after dilution; any unused portion of the diluted solution should be discarded.

A test dose equivalent to 25 mg of elemental iron, which has been diluted in 50 mL of 0.9% sodium chloride injection and given IV over 60 minutes, was recommended in the past by the manufacturer prior to administration of the first therapeutic dose of sodium ferric gluconate.

It has been suggested that administration of sodium ferric gluconate even at recommended dosage and infusion rates may result in adverse effects (e.g., hypotension, flushing) that have been attributed to oversaturation of transferrin and accompanying adverse effects. (See Acute Toxicity.) Although the cause of such adverse effects has not been fully elucidated, reducing the dose to 62.5 mg and infusing the drug over 4 hours has been shown to reduce the occurrence of adverse effects.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Hemochromatosis

• Chronic iron overload due to repeated blood transfusions
• Hemolytic anemia
• Hemosiderosis

There are no moderate contraindications for this drug.

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Less Frequent

• Infection
• Thrombotic disorder

Rare or Very Rare

• Acute myocardial infarction
• Anaphylaxis
• Angina
• Bradycardia
• Bronchospastic pulmonary disease
• Cyanosis
• Dyspnea
• Extravasation injury
• Hemoglobinuria
• Hemolysis
• Hemorrhage
• Hypersensitivity drug reaction
• Hypertension
• Hypotension
• Leukocytosis
• Pneumonia
• Pulmonary edema
• Seizure disorder
• Sepsis
• Urticaria

More Frequent

• Cramps
• Dyschromia
• Dysgeusia
• Headache disorder
• Hyperhidrosis
• Hypoesthesia

Less Frequent

• Pharyngitis
• Rhinitis

Rare or Very Rare

• Acute abdominal pain
• Acute cognitive impairment
• Anorexia
• Arthralgia
• Arthritis
• Back pain
• Chest pain
• Chills
• Constipation
• Cough
• Cramps in legs
• Diarrhea
• Dizziness
• Dyspepsia
• Eructation
• Fatigue
• Fever
• Flatulence
• Flu-like symptoms
• Flushing
• General weakness
• Hematuria
• Hypertonia
• Injection site sequelae
• Lymphadenopathy
• Myalgia
• Nausea
• Nervousness
• Pain
• Pallor
• Palpitations
• Paresthesia
• Peripheral edema
• Phlebitis after infusion
• Pruritus of skin
• Purpura
• Rectal pain
• Skin rash
• Tachycardia
• Upper respiratory infection
• Urinary tract infection
• Vasodilation of blood vessels
• Vomiting
• Xerostomia

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Reproductive studies in mice and rats using sodium ferric gluconate dosages up to 100 or 20 mg/kg daily, respectively, have not revealed evidence of harm to the fetus. These dosages were 1.3 or 3.24 times, respectively, the recommended human daily dosage of 125 mg or 92.5 mg/m2 (based on a patient of average height weighing 50 kg and having a body surface area of 1.46 m2). In a study involving 21 pregnant women who were treated with sodium ferric gluconate as an alternative to blood transfusions, dose-dependent adverse events occurred; these adverse events included sinus tachycardia, palpitations, shortness of breath, and hot flushes (flashes), which were transient and resolved spontaneously without treatment after a few minutes. There are no adequate and controlled studies to date using sodium ferric gluconate in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Since it is not known whether sodium ferric gluconate is distributed into milk, the drug should be used with caution in nursing women.

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