Ferrlecit (Sodium Ferric Gluconate) Dosing for 1 Gram Total Dose
Daily administration of 125 mg Ferrlecit until reaching a total dose of 1 gram is an FDA-approved dosing regimen that is safe and effective for iron repletion in patients with iron deficiency anemia.
FDA-Approved Dosing
According to the FDA label for Ferrlecit, the recommended dosage for iron repletion is 125 mg of elemental iron (10 mL) per dialysis session 1. For repletion treatment, most patients require a cumulative dose of 1000 mg (1 gram) of elemental iron, typically administered over 8 sessions 1.
The FDA label specifically states:
- Each 5 mL vial contains 62.5 mg of elemental iron (12.5 mg/mL)
- The recommended dose is 125 mg per session
- A cumulative dose of 1000 mg is typically required for repletion
- Sequential administration at dialysis sessions is appropriate 1
Administration Methods
Ferrlecit can be administered in two ways:
- Diluted: 125 mg (10 mL) diluted in 100 mL of 0.9% sodium chloride, administered by intravenous infusion over 1 hour
- Undiluted: As a slow intravenous injection at a rate of up to 12.5 mg/min 1
Safety Considerations
The FDA label includes an important safety warning that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events 1. This is supported by research showing that higher single doses (250-500 mg) are associated with increased adverse events:
- 10% of patients receiving 250 mg doses experienced adverse effects including nausea, vomiting, diarrhea, and burning sensations 2
- 30% of patients receiving 500 mg doses experienced more severe reactions including chills, severe nausea/vomiting, hypotension, and syncope 2
Alternative Dosing Approaches
While some research has explored higher individual doses:
- A study of 250 mg doses infused over 1 hour in hemodialysis patients found them generally well-tolerated, with only one patient developing pruritus 3
- Another study found 250 mg doses infused over 1-4 hours had a 5% rate of side effects 4
However, these higher doses are not FDA-approved and carry increased risk of adverse events compared to the standard 125 mg dose.
Monitoring and Follow-up
When administering Ferrlecit:
- Observe patients for at least 30 minutes following each IV injection to monitor for adverse reactions
- Monitor iron status 3 months after completing the full course
- Target ferritin levels >100 μg/L and hemoglobin >12 g/dL 5
Conclusion
Based on the FDA-approved labeling and safety profile, administering 125 mg of Ferrlecit daily (or per dialysis session) for a total cumulative dose of 1 gram is an appropriate dosing regimen. This approach balances efficacy in replenishing iron stores while minimizing the risk of adverse events associated with higher individual doses.