FERRLECIT - FERRLECIT Highlights

FERRLECIT Highlights

CONSISTENT IV IRON DELIVERY IS ESSENTIAL FOR CONSISTENT ANEMIA OUTCOMES

In iron repletion therapy, FERRLECIT leads to significant improvements in anemia outcomes and iron parameters
The efficacy of FERRLECIT has been evaluated in a randomized, controlled trial by Nissenson et al. (Am J Kidney Dis. 1999;33:471–482). In this pivotal trial, administration of 1000 mg of FERRLECIT (8 doses of 125 mg) resulted in significant improvements in hemoglobin, hematocrit, transferrin saturation (TSAT) and serum ferritin.[3] Serum ferritin levels stayed within the K/DOQI recommended target range of 100-800 ng/mL at all points during the study.[4,5]

Study Description
Study Design: Open-label, multicenter, randomized, comparative study of FERRLECIT 1000 mg total cumulative dose (n = 47, 8 doses of 125 mg over 16 to 17 days); FERRLECIT 500 mg total cumulative dose (n = 41, 8 doses of 62.5 mg over 16 to 17 days); and historical oral iron control (n = 25, retrospective data from hospital records).[4]

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Inclusion Criteria: Patients undergoing hemodialysis and epoetin therapy with ferritin <100 ng/mL or TSAT <18%; and hemoglobin <10 g/dL or hematocrit ≤32%. Patients were excluded if they had received IV iron in the preceding 2 months, if they had significant comorbid conditions, or if their baseline epoetin requirements were >10,000 U tiw. Patients with a history of allergic reactions to iron dextran were not excluded.[4]

Results:
Significant increases in hemoglobin [4]

•	Mean increase in hemoglobin of 1.0 g/dL 2 days after completion of a 1-gram course therapy administered over 8 sequential dialysis sessions

Significant improvement in iron parameters after 1-gram repletion dose [4]

•	Mean TSAT increased to >20% 2 days after completion of therapy
•	Mean serum ferritin levels increased 320 ng/mL 2 days after completion of therapy, and remained below the K/DOQI-recommended limit

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During Continued Iron Therapy

•	Demonstrated in prospective studies[21,22] to maintain mean hemoglobin, TSAT, and serum ferritin levels within K/DOQI-recommended ranges

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•	When given in regular doses (62.5 mg administered twice weekly, weekly, or every 2 weeks) FERRLECIT improved hemoglobin response to erythropoietin [23] and maintained body iron stores [24]

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