Ferric sodium gluconate

Shirley, NY) sodium ferric gluconate (Ferrlecit by Watson Pharmaceuticals, Inc., Corona, CA) and iron sucrose (Venofer by American Reagent, Inc., Shirley, NY). Initiation of IV iron should be based on evaluation of iron stores. A serum ferritin level less than 100 ng/mL in conjunction with a TSAT level less than 20% indicates absolute iron deficiency and is a clear indication for the need for iron replacement.31 When TSAT is less than 20% in conjunction with normal or elevated serum ferritin levels, treatment should be based on the clinical picture of the patient, as serum ferritin is an acute phase reactant, which may become elevated with inflammation and stress. Iron supplementation may be indicated if Hgb levels are below the goal level. 

When replacing iron stores in patients receiving ESA therapy, the general approach to treatment is to give a total of 1 g of IV iron, administered in smaller, sequential doses. Because iron stores deplete quickly in patients who do not receive iron supplementation, maintenance doses are often used, particularly in patients receiving hemodialysis. Maintenance doses consist of smaller doses of iron administered weekly or with each dialysis session (e.g., iron dextran or iron sucrose 20 to 100 mg per week sodium ferric gluconate 62.5 to 125 mg per week). 

Available parenteral iron preparations have similar efficacy but different pharmacologic, pharmacokinetic, and safety profiles (Table 33-5). The newer products, sodium ferric gluconate and iron sucrose, appear to be better tolerated than iron dextran. 

Sodium Ferric Gluconate Iron Dextran Iron Sucrose... 

Adverse effects of IV iron include allergic reactions, hypotension, dizziness, dyspnea, headaches, lower back pain, arthralgia, syncope, and arthritis. Some of these reactions can be minimized by decreasing the dose or rate of infusion. Sodium ferric gluconate and iron sucrose have better safety records than iron dextran. Iron dextran requires a test dose to reduce the risk of anaphylactic reactions. 

Sodium ferric gluconate complex 61 Sodium Polystyrene 61 Solu-Cortef 40 Solu-Medrol 48 Soma 21... 

The dosage of sodium ferric gluconate complex is expressed in milligrams of elemental iron. Each 5 mL ampule contains 62.5 mg elemental iron (12.5 mg/mL). 

Sodium ferric gluconate complex has been administered at sequential dialysis sessions by infusion or by slow IV injection during the dialysis session itself. 

Admixture incompatibility The compatibility of sodium ferric gluconate complex with IV infusion vehicles other than 0.9% sodium chloride has not been evaluated. 

Pharmacology Sodium ferric gluconate complex in sucrose injection is a stable macromolecular complex used to replete the total body content of iron. 

Metaboiism/Excretion-The terminal elimination half-life for drug bound iron was approximately 1 hour, varying by dose but not by rate of administration. Total clearance was 3.02 to 5.35 L/h. In vitro, less than 1 % of the iron species within sodium ferric gluconate complex can be dialyzed through membranes with pore sizes corresponding to 12,000 to 14,000 daltons over a period of up to 270 minutes. 

All anemias not associated with iron deficiency hypersensitivity to sodium ferric gluconate complex or any of its inactive components evidence of iron overload. 

Hypersensitivity reactions Serious hypersensitivity reactions have been rarely reported. One case of a life-threatening hypersensitivity reaction has been observed in a patient who received a single dose of sodium ferric gluconate complex in a postmarketing study. Three serious hypersensitivity reactions have been reported from the spontaneous reporting system. 

Children Safety and efficacy have not been established in pediatric patients younger than 6 years of age. Sodium ferric gluconate complex contains benzyl alcohol therefore, do not use in neonates. 

Iron overload Unnecessary therapy with parenteral iron will cause excess storage of iron with consequent possibility of iatrogenic hemosiderosis. Do not administer sodium ferric gluconate complex to patients with iron overload. 

Sodium ferric gluconate complex administered to patients during dialysis may cause transient hypotension. Administration may augment hypotension caused by dialysis. 

Adults - Adverse reactions experienced by at least 5% of patients receiving sodium ferric gluconate complex include the following abdominal pain, abnormal erythrocytes, asthenia, chest pain, cramps, diarrhea, dizziness, dyspnea, fatigue, fever, generalized edema, headache, hyperkalemia, hypertension, hypotension, injection-site reaction, leg cramps, nausea, pain, paresthesias, pruritus, syncope, tachycardia, upper respiratory tract infection, vomiting. 

The challenge with parenteral iron therapy is that parenteral administration of inorganic free ferric iron produces serious dose-dependent toxicity, which severely limits the dose of that can be administered. However, when the ferric iron is formulated as a colloid containing particles with a core of iron oxyhydroxide surrounded by a core of carbohydrate, bioactive iron is released slowly from the stable colloid particles. In the USA, the three available forms of parenteral iron are iron dextran, sodium ferric gluconate complex, and iron sucrose. 

Sodium ferric gluconate complex and iron-sucrose complex are alternative parenteral iron preparations. These agents can be given only by the intravenous route. They appear to be less likely than high-molecular-weight iron dextran to cause hypersensitivity reactions. 

Iron dextran, iron sucrose complex, and sodium ferric gluconate complex Parenteral preparations can cause hypersensitivity reactions ... 

Parenteral (Iron dextran) (InFeD, DexFerrum) 50 mg elemental iron/mL Parenteral (Sodium ferric gluconate complex) (Ferrlecit) 12.5 mg elemental iron/mL Parenteral (Iron sucrose) (Venofer) 20 mg elemental iron/mL Oprelvekin (IL-11) (Neumega)... 

Coyne DW, Adkinson NF, Nissenson AR, Fishbane S, Agarwal R, Eschbach JW, Michael B, Folkert V, Batlle D, Trout JR, Dahl N, Myirski P, Strobos J, Warnock DG. Ferlecit Investigators. Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney Int 2003 63(l) 217-24. 

Administration of 1 g of IV iron is reasonable to initially replete patients with an absolute iron deficiency (TSat <20%, serum ferritin < 100 ng/mL) however, many patients become iron deficient quickly without ongoing iron supplementation. There is sufficient evidence to support use of maintenance doses of IV iron (e.g., iron sucrose or iron dextran 25 to 100 mg/wk sodium ferric gluconate 62.5 to 125 mg/wk), particularly in hemodialysis patients. ... 

Seligman P, et al. Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects. Pharmacotherapy 2004 24 564-573. 

Michael B, et al. Sodium ferric gluconate complex in hemodialysis patients Adverse reactions compared to placebo and iron dextran. Kidney Int 2002 61 1830-1839. 

Folkert VW, et al. Chronic use of sodium ferric gluconate complex in hemodialysis patients Safety of higher-dose (> or = 250 mg) administration. Am J Kidney Dis 2003 41 651-657. 

Bolanos L, et al. Continuous intravenous sodium ferric gluconate improves efficacy in the maintenance phase of EPOrHu administration in hemodialysis patients. Am J Nephrol 2002 22 67-72. 

Total replacement doses of IV iron dextran have been given as a single dose, diluted in 250 to 1000 mL normal saline or 5% dextrose in water and infused over 4 to 6 hours. A test dose is still required. The ability to give a total dose infusion is a benefit of iron dextran over the other parenteral iron products. Iron dextran is best utilized when smaller frequent doses of sodium ferric gluconate or iron sucrose are impractical, such as with peritoneal dialysis. 

Sodium ferric gluconate is a parenteral iron preparation, which provides iron to replenish hemoglobin and depleted iron stores. It is indicated in the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis and supplemental erythropoietin. 

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