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Sodium Ferric Gluconate Complex Dosage

Applies to the following strength(s): 12.5 mg/mL

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

For repletion treatment of iron deficiency in hemodialysis patients receiving supplemental epoetin therapy:

10 mL (125 mg of elemental iron) intravenously during dialysis; may be diluted in 100 mL of 0.9% sodium chloride and administered by intravenous infusion over one hour, or administered undiluted as a slow intravenous injection at a rate of up to 1 mL/min (12.5 mg/min).

This dosage should not be exceeded. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

Most patients will require a minimum cumulative dose of 1 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. After that, patients may continue to receive treatment with intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits.

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure

For repletion treatment of iron deficiency in hemodialysis patients receiving supplemental epoetin therapy:

6 years or older: 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL of 0.9% sodium chloride and administered by intravenous infusion over one hour at eight sequential dialysis sessions.

The maximum dose should not exceed 125 mg. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Data not available

Precautions

The safety and efficacy of sodium ferric gluconate complex in pediatric patients younger than 6 years of age have not been established. In addition, the formulation contains benzyl alcohol and should not be used in neonates.

Treatment with sodium ferric gluconate complex requires monitoring of hemoglobin, hematocrit, and laboratory parameters of iron storage such as serum ferritin and transferrin saturation. Sodium ferric gluconate complex should be withheld in patients with evidence of iron overload, as iron accumulation in tissues can be toxic and may lead to iatrogenic hemosiderosis. Caution should be exercised in interpreting serum iron levels in the 24 hours following administration, since many laboratory assays will falsely overestimate serum or transferrin-bound iron by measuring iron still bound to the sodium ferric gluconate complex. Additionally, in the assessment of iron overload, caution should be exercised in interpreting serum ferritin levels in the week following administration. In clinical studies, serum ferritin exhibited a nonspecific rise which persisted for five days.

Hypotension characterized by lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin has been associated with intravenous administration of iron. These reactions are not related to hypersensitivity and have usually resolved within one or two hours. Volume expansion may be considered if hypotension is symptomatic. The incidence of hypotension following administration of injectable iron products may be related to the rate of administration and total dose administered. Therefore, sodium ferric gluconate complex should be administered in accordance with the manufacturer's dosage recommendations.

Sodium ferric gluconate complex should not be mixed with other medications, or added to parenteral nutrition solutions for intravenous infusion.

Dialysis

Sodium ferric gluconate complex is not significantly removed by hemodialysis and is generally administered during a dialysis session.

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