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Drug Criteria & Outcomes: Iron Complex Evaluation
By Bradley Gilchrist, PharmD, Clinical Pharmacist; Nathan Holder, PharmD, Clinical Pharmacist; and Richard Cramer, PharmD, Drug Information Coordinator, Department of Pharmacy, Huntsville (AL) Hospital
Dosage and administration
1. Iron sucrose
— Slow IV injection: Iron sucrose may be administered directly into the dialy- sis line at a rate of 1 mL (20 mg iron) undiluted solution per minute (five minutes per vial) not exceeding one vial (100 mg) per injection.
— Infusion: Iron sucrose may be admin- istered by infusion (into the dialysis line for hemodialysis patients), which can reduce the risk of hypotension. Each vial must be diluted in 100 mL NS, immediately prior to infusion, and given over at least 15 minutes.
2. Iron gluconate
3. Iron dextran
— Dose (mL) = 0.0442 (Desired hemoglobin (Hb)-Observed Hb) × lean body weight (LBW) + (0.26 × LBW).
— Iron replacement for blood loss: Replace- ment iron (mg) = blood loss (mL) x hematocrit.
Note: Iron sucrose and iron gluconate cannot be given as total drug infusions (i.e., their doses must be separated over several visits).
The safety profile of iron dextran is dependent upon its administration (see Table 1, below). When given as a daily IM or IV injection (100 mg), the adverse effect profile is quite low. The IV bolus infusion is associated with a greater frequency of side effects. Serious side effects can be reduced with the administration of a test dose.
There has been recent concern that iron sucrose is more often associated with increased risk of infection. Recent studies have demonstrated the promotion of bacterial growth in iron-overloaded patients attributed to free, unbound iron in the serum. Presence of free iron in the serum has also been identified as a source of inhibition of neutrophil killing capacity. Other trials, however, have not been able to demonstrate an association between supersaturated transferrin or IV iron administration and risk of infection.
Drug/lab and drug/drug interactions
Iron dextran may be given as a total daily dose due to its slow release. Iron sucrose and iron gluconate cannot be given as a total daily dose because they release iron more rapidly. Iron sucrose and iron gluconate do not require a test dose (physician’s discretion), whereas iron dextran does require a test dose before administration. Iron gluconate, iron sucrose, and iron dextran each have had reports of anaphylactic reactions; iron dextran carries a black box warning as a result.
Iron gluconate is more expensive per dose than iron sucrose, but the amount of elemental iron in each dose of iron gluconate is greater than that in iron sucrose (see Table 2, below). Iron dextran is a relatively inexpensive iron product compared to the other two products ($215 per 1,000 mg dose).
Iron dextran has been used safely and efficaciously for years and can be administered as a single daily dose. Additionally, it is significantly less expensive than the two newer agents. However, iron dextran is associated with a slightly higher incidence of allergic reactions, including life-threatening anaphylaxis. When comparing the other two IV products, we also must examine the efficacy, cost, and nursing time. Iron gluconate is typically given as a series of eight 125 mg injections, while iron sucrose is given as a series of ten 100 mg injections. The increased number of injections required for iron sucrose could increase cost even more due to increased nursing time and extra patient visits. Also, iron gluconate appears to have more studies supporting its efficacy than iron sucrose.
Iron sucrose and iron gluconate have both been used as alternative parenteral iron products at Huntsville Hospital for use in patients who are not able to receive iron dextran, such as those patients with a known allergy to it. Based on available data, iron gluconate and iron sucrose seem to be similar iron replacement products. The results found are not completely reliable due to the small sample sizes of each study.
Both iron sucrose and iron gluconate have been used without major administration problems in this hospital and the regional outpatient setting. Recently, iron gluconate has been used much more than iron sucrose in this region. Because of increased use of the product and other reasons discussed in this evaluation, iron gluconate is the hospital formulary agent and will be used in place of iron sucrose. Iron dextran will continue to be an IV iron formulary agent.
• American Regent Laboratories.
Venofer Formulary Monograph. Shirley, NY; 2003;1-32.
• American Regent Laboratories. Venofer Package Insert. Shirley, NY; 2003.
• Schein Pharmaceutical. InFeD Package Insert. Florham Park, NJ; 2003.
• Watson Pharma. Ferrlecit Package Insert. Florham Park, NJ; 2003.
• Iron sucrose. Drug Facts and Comparisons. St. Louis: Facts and Comparisons; 2001:36a-36b.
• Iron dextran. Drug Facts and Comparisons. St. Louis: Facts and Comparisons; 2000:33-35.
• Sodium ferric gluconate complex. Drug Facts and Comparisons. St. Louis: Facts and Comparisons; 2000:35-36.
• Personal communication. Cindy Hall, Buyer. Huntsville (AL) Hospital System; February 2004.
• Charytan C, Levin N, Al-Saloum M, et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis associated anemia: North American clinical trial. Clinical study report, 1999. Am J Kidney Dis 2001;37:300-307.
• Van Wyck DB, Cavallo G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis 2000;36:88-97.
• Silverberg DS, Blum M, Agbaria Z, et al. Intravenous ferric saccharate as an iron supplement in dialysis patients. Nephron 1996;72:413-417.
• Van Zyl-Smit R, Moosa MR, Potgieter CD, et al. A multicentre study to investigate the tolerance, safety, and efficacy of intravenous iron sucrose in hemodialysis patients with anemia. Clinical study report, 1997 and data on file: American Regent Laboratories; Shirley, NY. Abstract in Kidney Int 1999;55:2130.
• Macdougall IC, Chandler G, Elston O, et al. Beneficial effects of adopting an aggressive intravenous iron policy in a hemodialysis unit. Am J Kidney Dis 1999;34:S40-S48.
• Silverberg DS, Iaina A, Peer G, et al. Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis 1996;27:234-238.
• Hussain R, Christi SH, Navqi S. Experience of iron saccharate supplementation in haemodialysis patients treated with erythropoietin. Nephrology 1998;4:105-108.
• Iron dextran. Drug information handbook. Hudson (Cleveland): Lexi-Comp; 2000:643-644.
• Ferric gluconate. Drug information handbook. Hudson (Cleveland): Lexi-Comp; 2000: 688-689.
• Patruta SI, Edlinger R, Sunder-Plassman G, et al. Neutrophil impairment associated with iron therapy in hemodialysis patients with functional iron deficiency. J Am Soc Nephrol 1998;9:655-663.
• Parkkinen J, von Bonsdorff L, Peltonen S, et al. Catalytically active iron and bacterial growth in serum of hemodialysis patients after IV iron-saccharate administration. Nephrol Dial Transplant 2000;15:1827-1834.
• Deicher R, Ziai F, Cohen G, et al. High-dose parenteral iron sucrose depresses neutrophil intracellular killing capacity. Kidney Intl 2003;64:728-736.
• Hoen B, Paul-Dauphin A, Hestin D, et al. EPIBACDIAL: A multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients. J Am Soc Nephrol 1998;9:869-876.