Established Safety Profile

Demonstrated efficacy in pediatric patients ≥ 6 years of age

Significant increases in Hb1*

Effect of Ferrlecit repletion therapy on Hb in pediatric HD patients1*

* P < 0.02

Significant improvements in iron indices1*

  • Ferrlecit significantly increased TSAT (P < 0.02), serum ferritin (P < 0.0001), and reticulocyte hemoglobin content (CHr) (P < 0.05) vs baseline
  • Levels were within KDOQI-recommended targets at weeks 2 and 4 following dosing cessation2

Adverse Events in Pediatrics1

The most common adverse events, whether or not related to study drug, occurring in greater than 5% regardless of treatment group were: hypotension, headache, hypertension, tachycardia, vomiting, fever, nausea, abdominal pain, pharyngitis, diarrhea, infection, rhinitis, and thrombosis

Results based on a randomized, double-blind, parallel-group clinical trial in pediatric patients (N=66 enrolled, 56 completed) ages 6-15 years with a need for iron repletion therapy indicated by transferrin saturation (TSAT) < 20%, serum ferritin < 100 ng/mL, and receiving stable epoetin doses. Patients received Ferrlecit 1.5 mg/kg (Group 1) or Ferrlecit 3.0 mg/kg (Group 2) over 8 sequential dialysis sessions. Ferrlecit was administered without a test dose
1 to 2 hours after initiation of HD. Epoetin dose adjustments were only permitted between the 2- and 4-week evaluation time period. The primary efficacy endpoint was to compare mean changes in Hb, hematocrit (Hct), TSAT, serum ferritin, and CHr from baseline to 2 weeks after dosing cessation. Duration of treatment response compared above parameters from baseline to 4 weeks after dosing cessation. Safety was assessed by monitoring AE occurrence with regard to anaphylactic reactions, nonanaphylactic allergic reactions, and hypotensive events.1*

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. Warady BA, Zobrist RH, Wu J, Finan E; the Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex therapy in anemic children on hemodialysis. Pediatr Nephrol. 2005;20:1320-1327.

2. 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(5 suppl 3):S1-S145.

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