Established Safety Profile

Single-Dose Safety: Established with no test dose required1

Proven in the largest placebo-controlled safety study of IV iron in HD patients (n=2493)1*

No significant difference in serious adverse events (AEs) vs placebo (P=0.8450)1

  • 12.3% incidence of all AEs vs 9.8% with placebo
  • 3.9% vs 2.5% of patients experienced a treatment-related AE (P=0.0006 vs placebo)
  • No significant difference in post-administration hypotensive events (3.8%) vs placebo (3.3%) (P=0.25)
  • The most common treatment-related AEs were back pain, hypertension, dyspepsia, nausea, vomiting, hypotension, and flushing

1 of 2493 patients experienced a life-threatening reaction1

  • Symptoms resolved in 20 minutes without sequelae
  • Patient had a history of multiple drug allergies, including a previous history of anaphylaxis to iron dextran

* 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

Overall incidence is similar. However, difference becomes statistically significant by McNemar’s test after exclusion of 95 patients with reactions to both arms (P=0.0008).

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, Fishbane S, et al; for the Ferrlecit® Publication Committee. Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839.