Sodium ferric gluconate complex in sucrose injection
•
Ferric oxide saccharate complex chelated by gluconate carboxylic function[1,3] Hemodialysis patients with documented sensitivity to iron dextran have successfully received FERRLECIT.[2]
Pharmacokinetics
• The FERRLECIT iron complex is not dialyzable[1]
Iron movement in a study of iron-deficient healthy volunteers[1,3*]
Typical PK Profile—125 mg IV Push
•
About 80% of drug-bound iron administered to iron-deficient subjects delivered to transferrin within 24 hours[1,3]
•
Direct movement of iron from FERRLECIT to transferrin was not observed[1,3]
•
Elimination half-life approximately 1 hour as drug is taken up by RES[1,3]
*Clinical significance of these data to indicated population is unknown.
TSAT in a study of iron-deficient healthy volunteers[1,3*]
Transferrin Saturation—125 mg Fe
•
Mean peak transferrin saturation did not exceed
100%[1,3]
*Clinical significance of these data to indicated population is unknown.
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
