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
- 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
- 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.
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
3. Ferrlecit® Prescribing Information, sanofi-aventis