10 years of clinical experience

DRIVE results: Demonstrated efficacy in patients with high ferritin
and low Hb

Significant increases in Hb vs epoetin therapy alone

In patients with serum ferritin 500 ng/mL – 1200 ng/mL, TSAT ≤ 25%, and Hb ≤ 11 g/dL

  • Significantly greater increases in Hb from baseline vs the Control Group (P = 0.028)
  • 47% of patients achieved ≥ 2 g/dL Hb increase within 6 weeks vs 29% in the Control Group (P = 0.041)
  • Increases in Hb and TSAT regardless of baseline serum ferritin level

DRIVE and DRIVE II safety results

DRIVE II results: IV iron therapy did not significantly impact serum ferritin levels3

  • No significant change in serum ferritin at week 12 in the Ferric Gluconate Group (P=NS vs baseline)
  • Patients stratified to the higher serum ferritin group (>800 ng/mL) in DRIVE experienced little impact on serum ferritin levels

* The DRIVE (Dialysis Patients' Response to IV Iron With Elevated Ferritin) (n = 134) study was an open-label, randomized, controlled, 6-week multicenter study conducted in anemic (Hb ≤ 11 g/dL) HD patients receiving adequate epoetin therapy who had elevated serum ferritin levels (500-1200 ng/mL) and low TSAT (≤ 25%). After baseline, epoetin dosage was increased by 25% in both groups and was maintained through the course of the study. Patients were stratified by baseline serum ferritin ≤ 800 ng/mL or > 800 ng/mL and were randomly assigned 1:1 to either the control group (no iron, n = 65) or the Ferric Gluconate Group (1 g of Ferrlecit administered in 8 consecutive 125-mg doses, n = 64). The study's predefined primary objective was to compare the change in Hb levels from baseline to week 6 between treatment groups.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. Coyne DW, Kapoian T, Suki W, et al; the DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) study. J Am Soc Nephrol. 2007;18:975-984.

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. Kapoian T, O'Mara NB, Singh AK, et al. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008;19:372-379.