Safety of Intravenous Iron Following Infusion Reactions

Stojanovic, Stephanie; Graudins, Linda V; Aung, Ar Kar; Grannell, Louise; Hew, Mark; Zubrinich, Celia

doi:10.1016/j.jaip.2020.11.028

Cited by 23 publications

(33 citation statements)

References 12 publications

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“…AEs were significantly greater in patients who received the same IV iron formulation compared with those who switched to an alternate formulation, although notably higher rates of AEs in both groups were detected in those who were premedicated, supporting the theory that many of the documented reactions may instead be because of premedication itself, and not iron. Adding to a growing body of data to support the safety of IV iron rechallenge following an AE is a recently published large, retrospective cohort analysis conducted in Australia by Stojanovic et al 31 Sixty-nine patients who experienced an AE to IV iron polymaltose who did not complete their initial infusion were subsequently rechallenged with ferric carboxymaltose, of which 68 patients tolerated completion without incident, including 3 patients who experienced SAEs during their first IV iron infusion. General conclusions from these and other studies suggest that routine use of premedications be limited only to those with substantial risk factors (such as previous reaction to IV iron, fast infusion rate, multiple drug allergies, severe asthma or atopy 10 ), rechallenge to an alternate IV iron formulation is safe, and ultimately, future RCTs are needed to adequately study the ideal approach to both prevention and management of infusion-related reactions among all currently available IV iron formulations.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions

et al. 2022

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Key Points Question What are the overall incidence and comparative rates of infusion reactions among commonly used intravenous iron formulations? Findings In this multicenter cohort study of 35 737 iron infusions administered to 12 237 patients, the incidence of infusion reactions was 3.9%, with only 2 total documented epinephrine administrations. There were significantly different comparative rates of infusion-related adverse events among individual iron formulations, and the use of premedication was associated with greater risk of adverse events. Meaning These results suggest that intravenous iron administration is generally well tolerated, although it may differ among available iron formulations, with an exceedingly low risk of severe infusion reaction.

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Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions

et al. 2022

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“…Because FPC is administered as small doses (≈6.5 mg/treatment), the generation of toxic NTBI is unlikely. This analysis also demonstrates that FPC is not present in high‐molecular‐weight aggregates, which require processing in macrophages to release the iron and may contribute to some of the adverse drug reactions noted with m‐IVFe 17–20 …”

Section: Discussionmentioning

confidence: 75%

“…This analysis also demonstrates that FPC is not present in highmolecular-weight aggregates, which require processing in macrophages to release the iron and may contribute to some of the adverse drug reactions noted with m-IVFe. [17][18][19][20] Analysis of C max and AUC 0-last for pFe total and TBI were the co-primary end points in this study to demonstrate the equivalence of dialysate-delivered FPC iron to IV-administered FPC iron. When FPC was administered via HD, pFe total concentrations peaked at 4 hours after the start of HD and returned to baseline levels by 12 hours.…”

Section: Discussionmentioning

confidence: 90%

Pharmacokinetics and Safety of Intravenous Ferric Pyrophosphate Citrate: Equivalence to Administration via Dialysate

Marbury

Heuveln

Horst

et al. 2022

The Journal of Clinical Pharma

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Ferric pyrophosphate citrate (FPC) is indicated to maintain hemoglobin in patients with stage 5 hemodialysis-dependent chronic kidney disease on chronic hemodialysis by addition to the dialysate. An intravenous (IV) FPC presentation containing 6.75 mg of iron in 4.5 mL was developed. The objective was to establish the equivalence of iron delivery via dialysate and IV infusion using a pharmacokinetic approach. An open-label, randomized, multiple-period, single-dose, crossover study was conducted in 27 patients with CKD-5HD. Each patient received (1) a basal iron profile over 12 hours, (2) FPC 6.75 mg Fe IV predialyzer, (3) FPC 6.75 mg Fe IV postdialyzer, and (4) FPC 2 μM (110 μg Fe/L of hemodialysate). Serum and plasma iron was analyzed for total Fe and transferrin bound iron (TBI). Equivalence was determined by comparing maximum observed concentration and area under the concentration-time curve from time 0 to the last observation of 110 μg Fe/L of hemodialysate (reference) and test treatments Fe predialyzer and postdialyzer iron profiles. The main outcome measure was the measurement of bioequivalence between the reference and test treatments. Bioequivalence parameters showed that infusion of FPC iron IV, predialyzer and postdialyzer delivered equivalent iron as via hemodialysate. The increment in serum total Fe from predialysis to postdialysis was the same as observed in the long-term clinical studies of FPC. FPC IV was well tolerated. IV infusion of 6.75 mg iron as FPC during 3 hours of HD delivers an equivalent amount of iron as when Triferic is delivered via hemodialysate. The IV presentation of FPC extends the ability to provide FPC iron to all patients receiving hemodialysis or hemodiafiltration.

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“…(2015) распространенность реакций гиперчувствительности на фоне парентерального введения препаратов железа составляет около 0,1% [29]. Более высокая частота развития реакций гиперчувствительности (1,4%) на фоне применения препаратов железа была определена в ретроспективном исследовании, проведенном австралийскими исследователями на основании историй болезни пациентов с 1 января 2010 г. по 31 декабря 2019 г. в городской сети здравоохранения [30]. Среди основных факторов риска развития реакций гиперчувствительности на фоне введения препаратов железа исследователи выделяют следующие: быстрая скорость инфузии железа, отягощенный аллергологический анамнез пациента, тяжелая атопия, системные воспалительные заболевания [31].…”

Section: Discussionunclassified

Study of the Safety of Antianemic Preparations by Method of the System of Problems Related to Medicinal Preparations

Матвеев

Егорова²,

Коняева

et al. 2021

Farm. farmakol. (Pâtigorsk)

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Iron deficiency is the most common micronutrient deficiency worldwide. Prevention and treatment of iron deficiency conditions are some of the most important health problems in many countries of the world. At the same time, the main problems for it remain the timely diagnosis, elimination of the cause, as well as the choice of replacement therapy with iron-containing drugs and correction of adverse reactions (ADR) that occur during their use.The aim. This research aims to study the peculiarities of the development of antianaemic drugs ADRs in patients living in the territory of the Republic of Crimea.Materials and methods. The objects of research were cases of ADR occurrence associated with the use of a group of antianaemic drugs and revealed during the 2009-2018 period in the territory of the Republic of Crimea. The main tasks in the analysis of notification forms were the study of the ADR severity, the causality assessment for suspected drugs and ADRs, as well as analysis of particular problems associated with the use of antianaemic drugs (Drug-related problems, DRP).Results. Iron supplements in combination with other drugs became the leaders in the incidence of ADR among antianaemic drugs (28 cases, 42.4% of all cases of ADR). The largest number of cases was registered in patients aged from 18 to 30 years, with female patients prevailing. Among the clinical manifestations of ADR, the most cases were drug hypersensitivity reactions of varying severity (40 cases) and disorders of the gastrointestinal tract (18 cases). The study of the problems associated with the use of antianaemic drugs made it possible to determine that the highest rates of DRP values were observed with the use of iron preparations for parenteral use and cyanocobalamine. The minimal DRP values were observed when prescribing iron protein succinylate preparations.Conclusion. The basis of pharmacotherapy for various types of anemias is the replenishment of iron and vitamin B12 (cyanocobalamin) depots. The effectiveness of the treatment in these cases largely depends on the patient's adherence to treatment, which is, in turn, depends on the frequency and severity of ADRs that occur during the use of antianaemic drugs.

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Safety of Intravenous Iron Following Infusion Reactions

Cited by 23 publications

References 12 publications

Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions

Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions

Pharmacokinetics and Safety of Intravenous Ferric Pyrophosphate Citrate: Equivalence to Administration via Dialysate

Study of the Safety of Antianemic Preparations by Method of the System of Problems Related to Medicinal Preparations

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