Established Safety Profile

Ferrlecit dosing and administration

Ferrlecit administration1,2

  • No test dose required1
    • Safe administration as an IV push (12.5 mg/min) or by IV infusion over 1 hour (diluted in 100 mL of 0.9% sodium chloride)
  • Administration anytime during hemodialysis
  • Allows for accurate measurements of iron parameters without interrupting weekly therapy3

Adult dosage1

  • 1 g repletion therapy with Ferrlecit
    • Recommended dosage is 10 mL of Ferrlecit (125 mg of elemental iron)
    • Can be completed over 8 sequential dialysis treatment sessions
  • IV iron therapy after repletion treatment
    • Following initial repletion therapy, patients may continue to require IV iron, as recommended by KDOQI guidelines (22-65mg/wk), to achieve target levels of hemoglobin (Hb), hematocrit (Hct), and laboratory parameters of iron storage

Pediatric dosage for patients 6 years and older1

  • Recommended pediatric dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour at 8 sequential dialysis sessions
  • The maximum dosage should not exceed 125 mg per dose
Important Safety Information for Ferrlecit

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferrlecit (sodium ferric gluconate) in post marketing experience. Patients may present with shock, clinically significant hypotension, loss of consciousness, or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Ferrlecit is contraindicated in patients with known hypersensitivity to Ferrlecit.
  • Ferrlecit may cause clinically significant hypotension. Administration of Ferrlecit may augment hypotension caused by dialysis and usually resolves within one to two hours. Monitor patients for sign and symptoms of hypotension during and following administration.
  • Do not administer to patients with evidence of iron overload.
  • Ferrlecit contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Caution should be exercised when Ferrlecit is administered to a pregnant or nursing woman.
  • The most commonly reported adverse reactions (≥10%):
    • In adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps and pain.
    • In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.

For more information on Ferrlecit, please see full Prescribing Information.

References:

1. Ferrlecit® Prescribing Information, sanofi-aventis U.S. LLC.

2. Michael B, Coyne DW, Fishbane S, et al; for the Ferrlecit® Publication Committee. Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839.

3. National Kidney Foundation Kidney Disease Outcomes Quality Initiative. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis. 2006;47(suppl 3):S1-S145.