Ferric 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). 

Parenteral iron therapy currently is available in three different formulations, which are listed in Table 63-3. Iron dex-tran was the first parenteral iron formulation to be approved, followed by ferric gluconate, and then iron sucrose. Although these newer agents are only approved by the Food and Drug Administration (FDA) to treat anemia associated with CKD in patients receiving erythropoietin products, they are effective in treating iron-deficiency anemia as well. Iron dextran is FDA approved for treating documented iron deficiency in patients who are unable to tolerate the oral formulation. 

Iron-deficiency anemia in chronic PN patients may be due to underlying clinical conditions and the lack of iron supplementation in PN. Parenteral iron therapy becomes necessary in iron-deficient patients who cannot absorb or tolerate oral iron. Parenteral iron should be used with caution owing to infusion-related adverse effects. A test dose of 25 mg of iron dextran should be administered first, and the patient should be monitored for adverse effects for at least 60 minutes. Intravenous iron dextran then may be added to lipid-free PN at a daily dose of 100 mg until the total iron dose is given. Iron dextran is not compatible with intravenous lipid emulsions at therapeutic doses and can cause oiling out of the emulsion. Other parenteral iron formulations (e.g., iron sucrose and ferric gluconate) have not been evaluated for compounding in PN and should not be added to PN formulations. 

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. 

Hemodialysis Weekly IV iron sucrose (50-100 mg) or IV ferric gluconate (62.5-125 mg)—titrate doses... 

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)... 

Jain AK, Bastani B. Safety profile of a high dose ferric gluconate in patients with severe chronic renal insufficiency. J Nephrol 2002 15(6) 681-3. 

In a retrospective analysis of the incidence of adverse effects associated with 250 mg of ferric gluconate infused over 1-4 hours in 40 patients with severe chronic renal insufficiency, who received 79 treatments, four treatments in two patients were associated with adverse effects, including diarrhea, vomiting, low back pain, hypotension, and a burning sensation in the feet. The duration of the infusion did not influence the adverse effects profile. 

Iron deficiency is a common and important cause of poor response to erythropoietin in patients with severe chronic renal insufficiency, in whom oral iron supplements fail to correct iron deficiency (6). Ferric gluconate has a low adverse effects profile, but the recommended dose of 62.5-125 mg per treatment is not practical for patients... 

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. 

IV iron regimen may be divided over 8-10 HD sessions (depending on product used) or given in larger doses (eg, up to 500 mg iron dextran, 300 mg iron sucrose, 250 mg ferric gluconate) over a prolonged administration time for patients with early CKD or on PD. 

Intravenous iron preparations differ in the composition of the complex to which elemental iron is bound. These differences affect the rate of dissociation of iron from the complex to the reticuloendothelial system and subsequent storage as ferritin. Iron sucrose is also delivered directly to transferrin. The half-life of these formulations also differ ferric gluconate 1 hour, iron sucrose 6 hours, and iron dextran 40 to 60 hours. However, there is minimal to no correlation between the pharmacokinetics of these formulations and their pharmacodynamic effects. ... 

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