Established Safety Profile

Multiple Dose Safety: >13,000 doses were well tolerated in
1321 patients1*

  • 1 patient experienced a treatment-related serious AE
    • Following treatment, the patient received multiple doses of Ferrlecit without sequelae

Adapted from Michael B et al, 2004.

Low incidence of treatment-related adverse events (AEs) even in patients on concomitant ACE inhibitors1

  • 3.9% of patients experienced an AE possibly related to Ferrlecit
    • All AEs were classified as mild to moderate in severity
  • No correlation between AEs and dose, rate of infusion, and total amount of Ferrlecit administered
  • No significant difference in the incidence of drug-related AEs in patients receiving ACEI therapy

* 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.

Reference:

1. 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.