Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

Auerbach, Michael; Ballard, Harold S.

doi:10.1182/asheducation-2010.1.338

Cited by 275 publications

(233 citation statements)

References 69 publications

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“…The frequency of SAEs from prospective studies is extremely low but current reporting mechanisms tell us little about the relative frequency among products. Based on the preponderance of published evidence, IV iron is safe and probably much safer than most physicians realize, supporting a larger and earlier role for IV iron and raising the question of whether parenteral iron should be frontline therapy in conditions where oral iron will predictably be suboptimal [39].…”

Section: Safety Issuesmentioning

confidence: 99%

“…The characteristics of the available products are shown in Table III. While there is currently no FDA approval for these doses, LMW iron dextran, ferumoxytol, FCM, and iron isomaltoside can be given as a large replacement dose (up to 1,000 mg or more) in a single visit, while FG and IS must be given in lower doses due to infusion reactions above 250 mg and 300 mg, respectively [38,39].…”

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confidence: 99%

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How we diagnose and treat iron deficiency anemia

2015

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It is estimated that one‐third of the world's population is anemic, the majority being due to iron deficiency (ID). In adults, ID is associated with fatigue in the absence of anemia, restless legs syndrome, pica and, in neonates, delayed growth and development. In adolescents, ID is associated with decrements in learning and behavioral abnormalities. In the absence of a clear cause, search for a source of bleeding is indicated. No single test is diagnostic of ID unless the serum ferritin is low or the percent transferrin saturation is low with an elevated total iron binding capacity. Oral iron is considered front line therapy except for conditions such as gastric bypass, heavy uterine bleeding, inflammatory bowel disease, and hereditary hemorrhagic telangiectasia. Oral iron has many unpleasant side effects, resulting in low patient adherence. For patients intolerant of, or unresponsive to, oral iron, intravenous (IV) administration is the preferred route. While early formulations were associated with a high incidence of serious adverse events (SAEs), newer formulations are much safer with SAEs occurring very infrequently. Full replacement doses can be administered in a matter of minutes to a few hours. Nevertheless, there remains a reluctance to use IV iron due to a misunderstanding of the safety of the available formulations. IV iron is safe and effective in all clinical circumstances including pregnancy. The preponderance of published evidence suggests IV iron therapy is underutilized and we believe that IV iron should be moved forward in the treatment of ID and iron deficiency anemia (IDA). Am. J. Hematol. 91:31–38, 2016. © 2015 Wiley Periodicals, Inc.

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Section: Safety Issuesmentioning

confidence: 99%

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confidence: 99%

How we diagnose and treat iron deficiency anemia

2015

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“…The only formulation currently utilized in the US with which a full treatment course may be administered at a single sitting, total dose infusion (TDI), is low molecular weight (LMW) iron dextran [6]. The package insert recommends single bolus injections of 100 mg, however published reports suggest that 1,000 mg of iron dextran can be safely administered over 1-4 hr [7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min

et al. 2013

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For the majority of patients with iron deficiency anemia (IDA), a full course of intravenous (IV) iron is 1 g. Most IV irons require 5–10 administrations of 100–300 mg. We have successfully employed 1 g low molecular weight iron dextran over 1 hr. For further convenience for patients and physicians, we explored the administration of 1.02 g of ferumoxytol over 15 min instead of the approved 2 × 510 mg injections. Sixty patients with IDA, (hemoglobin <11 g/dL, transferrin saturation [TSAT] ≤20%, and ferritin <100 ng/mL) with an inadequate response or intolerance to oral iron, received 1020 mg ferumoxytol over 15 min. Vital signs were measured for 1 hr. Adverse events (AEs) were collected via telephone at 1, 2, and 7 days. Follow‐up visits occurred at 4 and 8 weeks for efficacy assessments. The primary endpoint was safety and tolerability. Secondary efficacy endpoints included mean change in hemoglobin, TSAT, and red cell distribution width. No serious adverse events (SAEs) occurred. Fifty‐eight patients received the planned dose. Twenty‐six out of sixty (43.3%) patients reported AEs of which 13 were mild and transient during infusion. All resolved within minutes. Fourteen patients reported self‐limited arthralgias, myalgias, and/or headache within 24–48 hr. At Baseline, the mean hemoglobin was 9.4 g/dL. The mean increments at Week 4 and 8 were 2.1 and 2.6 g/dL, respectively. Ferumoxytol, administered as 1.02 g infusion over 15 min was well tolerated with no SAEs and demonstrated excellent efficacy. If corroborated in future studies this represents an improved method of treating IDA. Am. J. Heamtol. 88:944–947, 2013. © 2013 The Authors. American Journal of Hematology published by Wiley Periodicals, Inc.

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“…15,16 While intravenous (IV) iron by passes these problems, fear remains about its harmful effects and the potential for long-term hazards from multiple doses of iron administration. 17,18 Parenteral iron preparations which were available in the olden days were associated with dangerous complications like anaphylactic reactions and death, due to which they have gone in disrepute. 19 The high-molecular-weight iron dextran formulation most frequently were responsible for these side effects seen in 2.3% of the patients.…”

Section: Discussionmentioning

confidence: 99%

Intravenous iron sucrose for treatment of anemia in gynecology patients awaiting surgery

Gandhi

Satia

2016

Int J Reprod Contracept Obstet Gynecol

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Background: Anemia refers to reduction in the total circulatory erythrocyte mass which results in decrease in the oxygen carrying capacity of the blood. Patients who require a surgical intervention as regards their complaints are many a times denied fitness because of anemia. Current anesthetic and surgical practice ideally recommend a hemoglobin level of > 10 g/dl or a hematocrit of >30 % for any surgical intervention. Surgery is postponed until cause of anemia is identified and the anemia corrected without resorting to blood transfusions. The current study evaluates other alternatives to increase the hemoglobin as early as possible without resorting to blood transfusion. The efficacy and safety of intravenous iron sucrose along with the achievement of the desired hemoglobin values for patients posted for elective gynecological surgeries within the next menstrual cycle was evaluated. Methods: This study was an open label, single arm, and prospective study of women with iron deficiency anemia in gynecological disorders. 100 patients attending Gynecology OPD of Seth G. S. Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, India requiring surgical intervention but not given fitness due to anaemia were the subjects of this study. All patients with surgically treatable conditions with hemoglobin level >7g/dL but < 10 g/dl were the inclusion criteria Selected subjects received intravenous iron sucrose. Maximum dose 200mg/weekX3 weeks initially. At the end of three weeks of starting therapy Hb estimation was done and compared with the baseline levels as regarding the hemoglobin rise. The results were statistically analyzed using the "paired t" test. Results: The requirement of iron-sucrose for the individual patient was calculated based on the weight of the patient. The analysis of iron requirement-sucrose combination showed a mean of 481.7 mg with standard deviation (SD) of 62.72 mg and a range of 378.85 mg. The minimum iron-sucrose requirement was 361.55 mg and the maximum was 740.40 mg The mean Hb (gm%) value before intervention was 8.43 with a standard deviation of 0.56, whereas, the mean Hb (gm %) value after intervention was higher, 10.41 with standard deviation (SD) of .56 the mean Hb (gm %) Increase in 2 weeks was 1.60 with standard deviation (SD) of 0.31, whereas, in 3 weeks was 2.03 with standard deviation (SD) of 0.51. The mean Hb (gm %) increase was higher in participants with 3 weeks, which was statistically significant (p<0.05). Conclusions: Parenteral iron therapy was not safe in the past but iron sucrose has made it the safest and effective therapy. Parenteral iron therapy can be used for patients with Hb level between 6-8mg/dl It is highly efficacious and reliable way to achieve the desired Hb level patient compliance is assured with intravenous iron sucrose patient can be satisfactorily posted for surgery within a period of 3 weeks i.e. within her next menstrual period by reliably and effectively correcting her anemia with intravenous iron sucrose.

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Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

Cited by 275 publications

References 69 publications

How we diagnose and treat iron deficiency anemia

How we diagnose and treat iron deficiency anemia

Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min

Intravenous iron sucrose for treatment of anemia in gynecology patients awaiting surgery

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