Expert consensus guidelines: Intravenous iron uses, formulations, administration, and management of reactions

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Abstract

Intravenous iron has become an essential component for the treatment of iron deficiency and iron deficiency anemia. Individuals administering Intravenous iron should have knowledge in intravenous iron administration, including a pre‐infusion assessment to evaluate infusion reaction risks, pre‐ and post‐infusion monitoring, identification of and management of infusion reactions, accurate documentation of these reactions, laboratory monitoring and recognition and management of treatment‐emergent hypophosphatemia. This comprehensive consensus provides step‐by‐step guidance and tools for practitioners to promote safe delivery of intravenous iron, recognition, and management of infusion reactions and treatment‐emergent hypophosphatemia.

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Ferric carboxymaltose in patients with heart failure and iron deficiency.

Stefan D. Anker, Josep Comín Colet, Gerasimos Filippatos … (2009)

Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia. We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life. Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780). Copyright 2009 Massachusetts Medical Society

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Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency†

Piotr Ponikowski, Dirk J van Veldhuisen, Josep Comin-Colet … (2014)

Aim The aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF). Methods and results CONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction ≤45%, elevated natriuretic peptides, and iron deficiency (ferritin <100 ng/mL or 100–300 ng/mL if transferrin saturation <20%). Patients were randomized 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalization for worsening HF. Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 ± 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 ± 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19–0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups. Conclusion Treatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalization for worsening HF (ClinicalTrials.gov number NCT01453608).

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Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

Iain C. Macdougall, Claire White, Stefan D. Anker … (2019)

Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited.

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Author and article information

Contributors

Layla Van Doren: (View ORCID Profile)

Michael Auerbach: (View ORCID Profile)

Journal

Title: American Journal of Hematology

Abbreviated Title: American J Hematol

Publisher: Wiley

ISSN (Print): 0361-8609

ISSN (Electronic): 1096-8652

Publication date (Electronic): January 29 2024

Affiliations

[1 ] Section of Hematology, Department of Medicine Yale School of Medicine New Haven Connecticut USA

[2 ] Infusion Nurses Society Norwood Massachusetts USA

[3 ] Florida Cancer Specialists and Research Institute Florida USA

[4 ] Parkview Packnett Cancer Center Fort Wayne Indiana USA

[5 ] FEM Iron Infusion Centers by Heme Onc Call Miami Florida USA

[6 ] Department of Medicine Georgetown University School of Medicine Washington District of Columbia USA

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DOI: 10.1002/ajh.27220

SO-VID: e1a7c42e-4567-49e7-9953-25d16054489e

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http://creativecommons.org/licenses/by-nc/4.0/

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Expert consensus guidelines: Intravenous iron uses, formulations, administration, and management of reactions

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Most cited references 65

Ferric carboxymaltose in patients with heart failure and iron deficiency.

Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency†

Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

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