FERRLECIT - FERRLECIT Highlights

FERRLECIT Highlights

CONSISTENT IV IRON DELIVERY FOR CONSISTENT ANEMIA OUTCOMES

Multiple-Dose Safety Study
The safety of FERRLECIT after repeated exposure has been studied in the clinical setting. In an open-label study of routine clinical practice involving 1321 hemodialysis patients who received multiple doses of FERRLECIT over a 9-month period, there were no life-threatening reactions after >13,000 exposures.[7] FERRLECIT was demonstrated to have a wide margin of safety in this study.[7]

Study Description
Objective: (1) To evaluate the adverse event profile of FERRLECIT after repeated administration, as would occur in routine clinical practice, and (2) to compare the incidence of adverse events following FERRLECIT administration in patients receiving and not receiving angiotensin-converting enzyme (ACE) inhibitors.

Study Design: Prospective, open-label, 9-month, multicenter surveillance study designed to record adverse events occurring up to 72 hours post-dose.

Patient Population: A total of 1321 adult hemodialysis patients with iron deficiency were evaluated.

Study Protocol: Over a 9 month evaluation period, each patient was assigned 20 ampules of FERRLECIT to be administered as needed. The dose, rate of infusion, and frequency of administration were at the local investigator’s discretion.

[ back to top ]

Study Results:

•	No life-threatening events occurred after 13,151 infusions of FERRLECIT over a 9-month period.
•	Of the serious adverse events, only 1 (0.1%), hypotension, was deemed related to FERRLECIT infusion. This patient subsequently received 6 doses of FERRLECIT without incident.
•	Five patients (0.4%) experienced an adverse event that precluded re-administration of drug: pruritus (3), vasodilation (1), and taste loss (1).
•	FERRLECIT-related adverse events did not correlate with dose, rate of infusion, repeated administration, or total exposure to FERRLECIT.
•	There were no significant differences in the rate of overall adverse events, drug intolerance, allergic reactions, or serious adverse events between patients receiving and not receiving ACE inhibitors.

Overall Incidence of Adverse Events

Type of Adverse Event		No. (%) n = 1321

Drug-related adverse event		51 (3.9)

Serious drug–related adverse event		1 (0.1)

Event precluding re-exposure		5 (0.4)

[ back to top ]

Author's Conclusions:

•	FERRLECIT is very well tolerated after repeated administration and multiple exposures, with no life-threatening reactions after >13,000 infusions.
•	Administration of FERRLECIT to patients using ACE inhibitors does not increase the incidence or severity of FERRLECIT-related adverse events.

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