Safety and efficacy of rapidly administered (one hour) one gram of low molecular weight iron dextran (INFeD) for the treatment of iron deficient anemia

Auerbach, Michael; Pappadakis, Jennifer A.; Bahrain, Huzefa; Auerbach, Sarah; Ballard, Harold S.; Dahl, Naomi V.

doi:10.1002/ajh.22153

Cited by 91 publications

(78 citation statements)

References 137 publications

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“…Also noted was that minor infusion reactions to FG were not accompanied by an increase in tryptase, a marker of mast cell degranulation, which would be expected if reactions were anaphylactic. One of us has reproduced this finding with both LMW iron dextran and ferumoxytol [41,42].…”

Section: Safety Issuesmentioning

confidence: 55%

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: 55%

How we diagnose and treat iron deficiency anemia

2015

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“…Iron dextran was initially introduced and approved for administration as a 100 mg undiluted bolus injection, however, over the last several decades it has become common clinical practice to administer a standard 1 g dose of LMW iron dextran over several hours. More recently, we have employed a significantly shorter administration time of 1 hr [11]. No premedication was given except to those with a history of more than one drug allergy or asthma for which steroids were administered prophylactically.…”

Section: Discussionmentioning

confidence: 99%

“…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]. Nonetheless, safety concerns abound.…”

Section: Introductionmentioning

confidence: 99%

“…Over the past 3 years, it has been our standard to treat IDA with IV iron, utilizing LMW iron dextran administered as a TDI of 1 g delivered over 1 hr. We recently published our experience with 1,266 such infusions administered to 888 consecutive, non-selected iron deficient patients with a variety of conditions associated with iron deficiency [11].…”

Section: Introductionmentioning

confidence: 99%

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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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“…9 Supporting their conclusions in a single institution observational study using a prospective model for the integrated safety analysis, 1266 total dose infusions (1000 mg in 1 h) of low molecular weight iron dextran were given to 888 patients, 162 of whom were pregnant, intolerant of oral iron, or in whom oral iron was ineffective or contraindicated. 10 No serious adverse events were observed. Low molecular weight iron dextran is the formulation currently being used for the first prospective study of intravenous iron in the second or third trimester of pregnancy in the US under an FDA IND (#114696).…”

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confidence: 91%