10 years of clinical experience

Efficacy in repletion therapy

Ferrlecit 1 g significantly increases hemoglobin (Hb) and iron markers

Loading Dose Study Hb
  • Hb approached KDOQI recommendations after a 1 g loading dose of Ferrlecit 1,2
  • Epoetin doses were unchanged throughout the study1
    • Exclusion criteria: patients receiving
      > 10,000 units 3x week1
Loading Dose Study TSAT
  • Transferrin saturation (TSAT) levels were within KDOQI recommendations1,3
  • Ferrlecit raised mean TSAT to > 20% for up to 30 days after the end of treatment1

Ferrlecit 1 g gets iron markers back on track

Loading Dose Study SF

A randomized, open-label efficacy and safety study that included a dose-response concurrent control and a historical control. Patients were randomly assigned to receive Ferrlecit at cumulative doses of either 500 mg over 30 minutes (low dose) (n=39) or 1000 mg over 60 minutes (high dose) (n=44) in 8 divided doses during sequential dialysis sessions.1

The Ferrlecit 1000 mg group demonstrated significantly better results vs the 500 mg group, which did not achieve significantly higher increases in hemoglobin and hematocrit (Hct) vs baseline.1

KDOQI=Kidney Disease Outcomes Quality Initiative.

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. Nissenson AR, Lindsay RM, Swan S, Seligman P, Strobos J. Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis. 1999;33:471-482.

2. National Kidney Foundation Kidney Disease Outcomes Quality Initiative. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease: 2007 Update of Hemoglobin Target. http://www.kidney.org/professionals/KDOQI/guidelines_anemiaUP/guide1.htm. Accessed September 23, 2009.

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.