FERRLECIT - FERRLECIT Highlights

FERRLECIT Highlights

CONSISTENT IV IRON DELIVERY FOR CONSISTENT ANEMIA OUTCOMES

Dextran Sensitivity

Well tolerated in iron dextran-sensitive patients

FERRLECIT has been shown to be well tolerated in patients with prior iron dextran sensitivity. A study by Coyne et al focused on the subset of 143 iron dextran-sensitive patients within the larger hemodialysis population evaluated by Michael et al in a prospective, randomized, placebo-controlled multicenter trial. Of these patients, 98% (140/143) received FERRLECIT without drug intolerance reactions.[8]

Coyne et al found that the incidences of allergic reactions to FERRLECIT and to placebo are significantly higher in dextran-sensitive patients than in iron dextran-tolerant patients. The observation that dextran-sensitive patients have a higher rate of allergic reactions even to placebo suggests that the reactions are not due to the drug administered but rather to immunologic factors in these patients.[8]

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Study Description
This was part of a larger prospective randomized, placebo-controlled study. Hemodialysis patients with or without previous iron dextran exposure were randomized to one of two treatment sequences: FERRLECIT (125 mg IV push over 10 minutes) at HD session 2 and placebo at HD session 3 OR placebo at HD session 2 and FERRLECIT at HD session 3. Patients who completed this double-blind trial with documented tolerance to FERRLECIT were eligible to enter an open-label trial where 1.25 g of FERRLECIT was administered within 9 months in any fashion at the local investigators’ discretion. The incidence of allergic reactions was compared between iron dextran-sensitive patients and iron dextran-tolerant patients.

Study Results

•	The incidence of FERRLECIT intolerance was 2.1% (3/143) among iron dextran-sensitive patients compared with 0.3% in iron dextran-tolerant patients (7/2194). Two of 3 drug intolerance events among iron dextran-sensitive patients were confirmed allergic reactions (as measured by a twofold increase in tryptase levels)
•	In all, 15 of the 2338 patients with previous iron dextran exposure had a suspected allergic reaction; the rate of allergic reactions following FERRLECIT administration was not significantly different from that following placebo administration
•	Suspected allergic events following FERRLECIT administration and following placebo were more common among iron dextran-sensitive patients than among iron dextran-tolerant patients.
•	FERRLECIT intolerance due to suspected allergic events (as measured by a twofold increase in tryptase levels) was significantly more common in iron dextran-sensitive patients (3/141, 2.1%) than in iron dextran-tolerant patients (5/2194, 0.2%)
•	Of the 92 dextran-sensitive patients who received multiple doses of FERRLECIT in the open-label extension of the trial, none experienced a serious adverse event.
•	None of the 8 iron dextran-sensitive patients who received at least one high dose of FERRLECIT (>125 mg) had a serious event, suspected allergic event, or drug intolerance.

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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