Each 5-mL ampule contains 62.5 mg elemental iron (12.5 mg/mL).[1]
•
The recommended dosage of FERRLECIT for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of FERRLECIT (125 mg).[1]
•
FERRLECIT may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour or administered undiluted as a slow IV injection (up to 12.5 mg/min).[1]
•
Most patients will require a minimum cumulative dose of 1.0 g elemental iron, administered over 8 sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response.[1]
•
Patients may continue to require therapy with intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits.[1]
K/DOQI Dosing Guidelines
•
K/DOQI recommendation for administering FERRLECIT in adult hemodialysis patients with absolute iron deficiency is 125 mg during each dialysis session for 8 doses.[5]
•
For maintenance iron therapy, and treatment and prevention of functional iron deficiency, the Anemia Work Group recommendation is 31.25 to 125 mg FERRLECIT every week for 8 weeks.[5]
Note: Do not mix FERRLECIT with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of FERRLECIT with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted in saline, use immediately after dilution.
References:
1.
Ferrlecit Full Prescribing Information, Watson Pharma, Inc.
2.
Data on file. Watson Pharma, Inc.
3.
Seligman PA, Dahl NV, Strobos J, et al. Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects. Pharmacotherapy. 2004;24(5)574-583.
4.
Nissenson AR, Lindsay RM, Swan S, et al. Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patiens: North American clinical trial. Am J Kidney Dis. 1999;33:471-482.
5.
National Kidney Foundation Dialysis Outcomes Quality Initiative/Kidney Disease Outcomes Quality Initiative. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease. III. Iron Support. New York: National Kidney Foundation; 2000.
6.
Beckie Michael, Daniel W. Coyne, Steven Fishbane, et al. Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839. or Michael B, Coyne DW, Fishbane S, et al. Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839.
7.
Beckie Michael, Daniel W. Coyne, Vaughn W. Folkert, et al. Sodium ferric gluconate complex in hemodialysis patients: a prospective evaluation of long-term safety. Nephrol Dial Transplant. 2004;19:1576-1580.
8.
Coyne DW, Adkinson NF Jr, Nissenson AR, et al. Sodium ferric gluconate complex in hemodilaysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney Int. 2003;63:217-224.
9.
Sirken GR, Qureshi M, Bloom EJ, et al. Association of iron sucrose and ferric gluconate with the infection rate in chronic hemodialysis patients. Poster presented at: Annual Meeting of the American Society of Nephrology; November 12-17, 2003; San Diego, CA.
10.
Lee GR. Iron deficiency and iron-deficiency anemia. In: Lee GR, Foerster J, Lukens J, Paraskevas F, Greer JP, Rodgers GM, eds. Wintrobe’s Clinical Hematology. 10th ed. Baltimore, MD: Williams & Wilkins;1999:979–1010.
11.
Hudson JQ, Comstock TJ. Considerations for optimal iron use for anemia due to chronic kidney disease. Clin Ther. 2001;23:1637–1671.
12.
Jacobs A, Worwood M. Ferritin in serum: clinical and biochemical implications. N Engl J Med. 1975;292:951–956.
13.
Bainton DF, Finch CA. The diagnosis of iron deficiency anemia. Am J Med. 1964;37:62–70.
14.
Besarab A, Amin N, Ahsan M et al. Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients. J Am Soc Nephrol. 2000;11:530–538.
15.
Fishbane S, Galgano C, Langley RC Jr, et al. Reticulocyte hemoglobin content in the evaluation of iron status of hemodialysis patients. Kidney Int. 1997;52:217–222.
16.
Mittman N, Sreedhara R, Mushnick R, et al. Reticulocyte hemoglobin content predicts functional iron deficiency in hemodialysis patients receiving rHuEPO. Am J Kidney Dis. 1997;30:912–922.
17.
Jacobsson S. Clinical value of serum transferrin measurements. J Int Fed Clin Chem. 2001;13:1–8.
18.
Ahluwalia N, Skikne BS, Savin V, Chonko A. Markers of masked iron deficiency and effectiveness of EPO therapy in chronic renal failure. Am J Kidney Dis. 1997;30:532–541.
19.
Chiang WC, Tsai TJ, Chen YM, et al. Serum soluble transferrin receptor reflects erythropoiesis but not iron availability in erythropoietin-treated chronic hemodialysis patients. Clin Nephrol. 2002;58:363–369.
20.
NKF-DOQI Anemia Work Group. NKF-DOQI clinical practice guidelines for the treatment of anemia of chronic renal failure. Am J Kidney Dis. 2001;37(suppl 1):S182-S238.
21.
Bolanos L, Castro P, Falcon TG, Mouzo R, Varela JM. Continuous intravenous sodium ferric gluconate improves efficacy in the maintenance phase of EPOrHu administration in hemodialysis patients. Am J Nephrol. 2002;22:67-72.
22.
Kosch M, Bahner U, Bettger H, Matzkies F, Teschner M, Schaefer RM.A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo. Nephrol Dial Transplant. 2001;16:1239-1244.
23.
Taylor JE, Peat N, Porter C, Morgan AG. Regular low-dose intravenous iron therapy improves response to erythropoietin in haemodialysis patients. Nephrol Dial Transplant. 1996;11:1079-1083.
24.
Navarro JF, Teruel JL, Liano F, Marcen R, Ortuno J. Effectiveness of intravenous administration of Fe-gluconate-Na complex to maintain adequate body iron stores in hemodialysis patients. Am J Nephrol. 1996;16:268-272.
Safety Information
FERRLECIT is contraindicated in non iron-deficient
anemias, in patients hypersensitive to FERRLECIT or its inactive components, or with evidence of iron overload
• Hypersensitivity reactions have been reported with injectable iron products
• Hypotension has been reported with rapid administration of IV iron
• In a single-dose, placebo-controlled safety study (n=1097), the most frequent adverse events occurring after
FERRLECIT administration were hypotension, nausea, and vomiting and/or diarrhea
• In multiple-dose studies (n=126), the most frequent adverse events, whether or not related to FERRLECIT
administration, were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps, hypertension,
dizziness, dyspnea, and chest pain
• Please see full prescribing information for
Warnings, Precautions, and Adverse Reactions
