Ferrlecit® is an iron replacement product for the treatment of iron
deficiency anemia in adult patients and in patients age 6 years and older with chronic
kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
A proven choice to fit your anemia treatment needs1,2
- Established efficacy and safety—10+ years of clinical experience
- Support for your dialysis center—professional and patient education, reimbursement
and patient assistance resources
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.
Ferrlecit is a registered trademark of A. Nattermann & Cie. GmbH.
References:
1. Ferrlecit® Prescribing Information, sanofi-aventis
U.S. LLC.
2. National Kidney Foundation Kidney Disease Outcomes Quality Initiative.
KDOQI clinical practice guidelines and clinical practice recommendations for anemia
in chronic kidney disease. Am J Kidney Dis. 2006;47(5 suppl 3):S1-S145.