Established Safety Profile

Treat iron deficiency anemia with experience and confidence

Established safety with a low incidence of treatment-related AEs (nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes, dyspnea, chest pain, leg cramps, and pain)1-3

  • Studies conducted exclusively in HD patients
  • Studies did not exclude patients with known sensitivity to iron dextran or receiving concomitant ACE inhibitors

* The single-dose study, the largest placebo-controlled safety study of IV iron in HD patients, was a multicenter, crossover, randomized, double-blind, placebo-controlled prospective comparative safety study performed in hemodialysis patients (2534 enrolled, 2493 completed). Patients were randomized into 1 of 2 treatment schedules. In the first group, 1264 patients received Ferrlecit in their second scheduled dialysis session, followed by placebo at their following session. In the second group, 1270 patients received placebo at the second dialysis session, and Ferrlecit at the following session. Historical control was based on a meta-analysis of publications examining outcomes in patients exposed to iron dextran.1

This study was a prospective, open-label, multicenter, surveillance study of the safety of repeated doses of Ferrlecit in anemic HD patients (1412 enrolled, 1321 completed). Patients who completed the preceding single-dose study of Ferrlecit were invited to participate. Patients were assigned to receive 20 doses (62.5 mg each) of Ferrlecit over a 9-month period. The frequency and rate of infusion was at the investigator’s discretion to reflect routine clinical use. Patients were assessed for AEs at the dialysis session when they received Ferrlecit and at their next dialysis session.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. Michael B, Coyne DW, Fishbane S, et al; for the Ferrlecit® Publication Committee. Sodium ferric gluconate complex in hemodialysis patients: adverse effect compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839.

2. Michael B, Coyne DW, Folkert VW, Dahl NV, Warnock DG; for the Ferrlecit® Publication Committee. Sodium ferric gluconate complex in hemodialysis patients: a prospective evaluation of long-term safety. Nephrol Dial Transplant. 2004;19:1576-1580.

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