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Ferrlecit (Sodium Ferric Gluconate Complex) - Summary

 
 



FERRLECIT SUMMARY

Ferrlecit® (sodium ferric gluconate complex in sucroseinjection) is a stable macromolecular complex with anapparent molecular weight on gel chromatography of 289,000-440,000 daltons.

Ferrlecit® (sodium ferric gluconate complex in sucrose injection) is indicated for treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Ferrlecit (Sodium Ferric Gluconate)

Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers. [2011.08]
OBJECTIVE: Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent... CONCLUSIONS: A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

Single-dosage pharmacokinetics of sodium ferric gluconate complex in iron-deficient pediatric hemodialysis patients. [2007.11]
BACKGROUND AND OBJECTIVES: The clinical use of sodium ferric gluconate complex in iron-deficient pediatric patients receiving hemodialysis was recently approved. This study was designed to describe the pharmacokinetic parameters of the medication... CONCLUSIONS: The infusion of sodium ferric gluconate complex to pediatric patients who receive hemodialysis appears to result in a delayed transfer of iron to transferrin, likely after an initial movement through the reticuloendothelial system. Differences noted between the pediatric and adult pharmacokinetic data may result from the unique aspects of the study populations and the respective study designs.

Sodium ferric gluconate complex therapy in anemic children on hemodialysis. [2005.09]
Pediatric patients with end-stage renal disease undergoing hemodialysis (HD) frequently develop anemia.Given the equivalent efficacy of the two doses, an initial dosing regimen of 1.5 mg kg(-1) is recommended for pediatric HD patients.

Sodium ferric gluconate causes oxidative stress but not acute renal injury in patients with chronic kidney disease: a pilot study. [2005.01]
BACKGROUND: Intravenous (i.v) iron is widely used to treat anaemia in patients with chronic kidney disease (CKD). Although beneficial and usually well tolerated, concerns have been raised about its ability to cause oxidative stress and renal injury... CONCLUSIONS: I.v. ferric gluconate caused oxidative stress (as reflected by increased MDA), but this was not associated with biochemical manifestations of acute renal injury.

Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects. [2004.05]
STUDY OBJECTIVES: To determine the single-dose pharmacokinetics of intravenous sodium ferric gluconate complex in sucrose injection (SFGC) in iron-deficient human volunteers, and to assess iron transport... CONCLUSIONS: Iron derived from SFGC appears to be rapidly transferred to a bioavailable iron compartment as transferrin-bound iron after digestion in the RES. At the doses administered in this study, liberation of potentially toxic, free iron was not detectable.

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Clinical Trials Related to Ferrlecit (Sodium Ferric Gluconate)

Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients. [Active, not recruiting]

Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients [Completed]
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients [Completed]
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Effect of Ferrlecit® Versuss Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents [Completed]
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peritoneal Dialysis Patients. [Completed]
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1: 1:1 ratio.

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Reports of Suspected Ferrlecit (Sodium Ferric Gluconate) Side Effects

Abdominal Pain (2)Circulatory Collapse (2)Back Pain (2)Dyspnoea (2)Nausea (2)Toxicity TO Various Agents (2)Application Site Swelling (1)Tachycardia (1)Headache (1)Oropharyngeal Pain (1)more >>


Page last updated: 2011-12-09

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