Iron sucrose

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. 

Administer supplemental iron IV 1 g in divided deses (sedium ferric glucenate or iron sucrose)0 po 200 mg elemental iron (consider in PD or early-stage CKD patients without IV access)... 

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

The dosage of iron sucrose is expressed in terms of milligrams of elemental iron. Each 5 mL vial contains 100 mg of elemental iron (20 mg/mL). 

Iron sucrose must be only administered IV (directly into the dialysis line) either by slow injection or by infusion. 

Slow IV injection In chronic renal failure patients, iron sucrose may be administered by slow IV injection into the dialysis line at a rate of 1 ml (20 mg iron) undiluted solution per minute (ie, 5 min/vial) not exceeding 1 vial of iron sucrose (100 mg elemental iron) per injection. Discard any unused portion. 

Infusion Iron sucrose may be also administered by infusion (into the dialysis line for hemodialysis patients). This may reduce the risk of hypotensive episodes. The content of each vial must be diluted exclusively in a maximum of 100 ml of 0.9% NaCI, immediately prior to infusion. Infuse the solution at a rate of 100 mg of iron over a period of 15 minutes or more. Discard unused diluted solution. 

IVincompatibility Do not mix iron sucrose with other medications or add to parenteral nutrition solutions for IV infusion. 

Pharmacokinetics In healthy adults treated with IV doses of iron sucrose, its iron component exhibits first order kinetics with an elimination half-life of 6 hours, total clearance of 1.2 L/h, non-steady-state apparent volume of distribution of 10 L, and steady-state apparent volume of distribution of 7.9 L. 

Following IV administration of iron sucrose, it is dissociated into iron and sucrose by the reticuloendothelial system. The sucrose component is eliminated mainly by urinary excretion. Some iron also is eliminated in the urine. 

Evidence of iron overload known hypersensitivity to iron sucrose or any of its inactive components anemia not caused by iron deficiency. 

Hypotension Hypotension has been reported frequently in patients receiving IV iron. Hypotension following administration of iron sucrose may be related to rate of administration and total dose administered. Take caution to administer iron sucrose according to recommended guidelines. 

Hypersensitivity reactions Serious hypersensitivity reactions have been rarely reported in patients receiving iron sucrose. No life-threatening hypersensitivity... 

Children Safety and efficacy of iron sucrose in pediatric patients have not been established. 

Monitoring Exercise caution to withhold iron administration in the presence of evidence of tissue iron overload. Periodically monitor hematologic and hematinic parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation). Withhold iron therapy in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose thus, serum iron values may be reliably obtained 48 hours after IV dosing. 

Drug interactions involving iron sucrose have not been studied. However, like other parenteral iron preparations, iron sucrose may be expected to reduce the absorption of concomitantly administered oral iron preparations. Do not administer concomitantly with oral iron preparations. 

Adverse events whether or not related to iron sucrose administration reported by more than 5% of treated patients are as follows hypotension (36%) cramps/leg cramps (23%) nausea, headache, vomiting, and diarrhea. 

Dexferrum, INFeD) Iron Sucrose (Venofer) Magnesium Oxide (Mag-Ox 400, others)... 

WARNING Anaphylactic Rxns w/ use use only if oral Fe not possible administer where resuscitation techniques available Uses Fe deficiency when cannot supl PO Action Fe supl Dose Adul. Iron defic anemia Estimate Fe deficiency, give 25-100 mg IM/IV /d until total dose total dose (mL) = [-.0442 x (desired Hgb - observed Hgb) x LBW] + (0.26 x LBW) Iron replacement, blood loss Total dose (mg) = blood loss (mL) x Hct (as decimal fraction) max 100 mg/d Peds >4 mo. As for adults max 0.5 mL (wt <5 kg), 1 mL (5-10 kg), 2 mL (>10 kg) p dose IM or direct IV Caution [C, M] Contra Anemia w/o Fe deficiency. Disp Inj SE Anaphylaxis, flushing, dizziness, inj site inf Rxns, metallic taste Interactions X Effects W/ chloramphenicol, X absorption of oral Fe EMS Anaphylactic Rxns common taking oral Fe t risk of tox and SEs OD May cause N/V, HA, muscle/joint pain and fev symptomatic and supportive Iron Sucrose (Venofer) [Iron Supplement] Uses Fe deficiency anemia w/ chronic HD in those receiving erythropoietin Actions Fe r lacement. Dose 5 mL (100 mg) IV on dialysis, 1 mL (20 mg)/min max Caution [C, M] Contra Anemia w/o Fe deficiency Disp Inj SE Anaphylaxis, -1- BP, cramps, N/V/D, HA Interactions i Absorption OF oral Fe supls EMS See Iron Dextran OD See Iron Dextran... 

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)... 

Auerbach M, Al Talib K Low-molecular weight iron dextran and iron sucrose have similar comparative safety profiles in chronic kidney disease. Kidney Int 2008 73 528. [PMID 18274543]... 

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