Ferric Carboxymaltose

Cada, Dennis J.; Levien, Terri; Baker, Danial E.

doi:10.1310/hpj4901-52

Cited by 11 publications

(6 citation statements)

References 27 publications

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“…Although listed in the drug label as a potential side effect, the overall incidence and the clinical relevance of this adverse event are largely unknown. 11,60,61 This systematic review and meta-analysis show that the reported incidence of hypophosphataemia after infusion of FCM or IIM ranges from 0% to 92% of in prospective clinical trials. Our systematic review and meta-analysis show that this wide range is in part attributable to inconsistent assessment and reporting of hypophosphataemia in clinical studies.…”

Section: Resultsmentioning

confidence: 97%

Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside—a systematic review and meta‐analysis

Schaefer

Tobiasch

Viveiros

et al. 2020

Brit J Clinical Pharma

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Aims: Hypophosphatemia is an increasingly recognized side-effect of ferric carboxymaltose (FCM) and possibly iron isomaltoside/ferric derisomaltose (IIM), which are used to treat iron deficiency. The aim of this study was to determine frequency, severity, duration and risk factors of incident hypophosphatemia after treatment with FCM and IIM. Methods: A systematic literature search for articles indexed in EMBASE, PubMed and Web of Science in years 2005 to 2020 was carried out using the search terms 'ferric carboxymaltose' OR 'iron isomaltoside'. Prospective clinical trials reporting outcomes on hypophosphatemia rate, mean nadir serum phosphate and/or change in mean serum phosphate from baseline were selected. Hypophosphatemia rate and severity were compared for studies on IIM vs. FCM after stratification for chronic kidney disease. Meta-regression analysis was used to investigate risk factors for hypophosphatemia. Results: Across the 42 clinical trials included in the meta-analysis, FCM induced a significantly higher incidence of hypophosphatemia than IIM (47%, 95% CI 36-58% vs. 4%, 95% CI 2-5%), and significantly greater mean decreases in serum phosphate (0.40 versus 0.06 mmol/L). Hypophosphatemia persisted at the end of the study periods (maximum 3 months) in up to 45% of patients treated with FCM. Meta-regression analysis identified low baseline serum ferritin and transferrin saturation, and normal kidney function as significant predictors of hypophosphatemia. Conclusion: FCM is associated with a high risk of hypophosphatemia, which does not resolve for at least 3 months in a large proportion of affected patients. More severe iron deficiency and normal kidney function are risk factors for hypophosphatemia.

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Section: Resultsmentioning

confidence: 97%

Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside—a systematic review and meta‐analysis

Schaefer

Tobiasch

Viveiros

et al. 2020

Brit J Clinical Pharma

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“…In terms of efficacy, our study was similar to prospective studies showing a rapid elevation in hemoglobin and ferritin levels [ 36 , 37 ]. Regarding side effects, in clinical trials, serious anaphylactic/anaphylactoid reactions have been reported in 0.1% of patients treated with FCM [ 38 ]. Other serious reactions potentially related to hypersensitivity, including pruritus, rash, urticaria, wheezing, or hypotension, were experienced by 1.5% of cases versus 3.8% of patients with hypertension [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

“…Other serious reactions potentially related to hypersensitivity, including pruritus, rash, urticaria, wheezing, or hypotension, were experienced by 1.5% of cases versus 3.8% of patients with hypertension [ 39 ]. Hypophosphatemia is not systematically assessed in clinical trials but when done its rate is about 2.1% [ 38 ], while other studies have reported higher rates. In the study assessing the effect of a single dose of FCM in fatigued women, Favrat et al [ 28 ] have indeed found that 86% of patients had a phosphate level <0.8 mmol/L at day 7 which resolved spontaneously before the end of the study in almost all FCM-treated patients; however, no data on the risk of profound hypophosphatemia (<0.32 mmol/L), fatigue persistence, and hypophosphatemia development were reported.…”

Section: Discussionmentioning

confidence: 99%

Intravenous Iron Administration and Hypophosphatemia in Clinical Practice

Hardy

Vandemergel

2015

International Journal of Rheumatology

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Introduction. Parenteral iron formulations are frequently used to correct iron deficiency anemia (IDA) and iron deficiency (ID). Intravenous formulation efficacy on ferritin and hemoglobin level improvement is greater than that of oral formulations while they are associated with lower gastrointestinal side effects. Ferric carboxymaltose- (FCM-) related hypophosphatemia is frequent and appears without clinical significance. The aim of this study was to assess the prevalence, duration, and potential consequences of hypophosphatemia after iron injection. Patients and Methods. The medical records of all patients who underwent parenteral iron injection between 2012 and 2014 were retrospectively reviewed. Pre- and postinjection hemoglobin, ferritin, plasma phosphate, creatinine, and vitamin D levels were assessed. Patients who developed moderate (range: 0.32–0.80 mmol/L) or severe (<0.32 mmol/L) hypophosphatemia were questioned for symptoms. Results. During the study period, 234 patients received iron preparations but 104 were excluded because of missing data. Among the 130 patients included, 52 received iron sucrose (FS) and 78 FCM formulations. Among FS-treated patients, 22% developed hypophosphatemia versus 51% of FCM-treated patients, including 13% who developed profound hypophosphatemia. Hypophosphatemia severity correlated with the dose of FCM (p = 0.04) but not with the initial ferritin, hemoglobin, or vitamin D level. Mean hypophosphatemia duration was 6 months. No immediate clinical consequence was found except for persistent fatigue despite anemia correction in some patients. Conclusions. Hypophosphatemia is frequent after parenteral FCM injection and may have clinical consequences, including persistent fatigue. Further studies of chronic hypophosphatemia long-term consequences, especially bone assessments, are needed.

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“…The National Institute for Health and Care Excellence (NICE) guideline recommends IV iron formulations [such as ferric carboxymaltose (FCM)] that allow a high-dose low-frequency strategy for ND-CKD patients [ 8 ]. FCM is a stable, non-dextran iron formulation providing a rapid and efficient repletion of iron stores [ 9 , 10 ] with a controlled delivery of high iron doses into target tissues. In addition, the European Society of Cardiology guideline goes beyond the nephrologist perspective and recommends the use of FCM in patients with heart failure with reduced ejection fraction and iron deficiency with or without anaemia [ 11 ], given the positive results observed in randomized clinical trials [ 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of ferric carboxymaltose therapy in peritoneal dialysis patients: an observational study

Pórtoles

Dura-Gurpide

Merino-Rivas

et al. 2019

Clinical Kidney Journal

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Background The efficacy of intravenous (IV) ferric carboxymaltose (FCM) has been demonstrated in haemodialysis and non-dialysis studies, but evidence is lacking in patients undergoing peritoneal dialysis (PD). Methods This multicentre, retrospective study evaluated the effectiveness and safety of FCM in patients on PD over 12 months. We retrospectively reviewed the electronic medical records of PD patients who initiated FCM treatment between 2014 and 2017 across seven Spanish centres. Results Ninety-one patients were included in the safety population (mean ± SD age 57.7 ± 15.0 years) and 70 in the efficacy population (mean age 50.9 ± 14.5 years). No hypersensitivity reaction, FCM discontinuation or dose adjustment due to a serious adverse event (SAE) was registered in the safety population. The most common non-SAEs reported were headache (four events), mild hypotension (three events) and hypertension (two events), among others. In the efficacy population (n = 70), 68.6% of patients achieved ferritin levels of 200–800 ng/mL, 78.4% achieved transferrin saturation (TSAT) >20%, and 62.8% achieved TSAT >20% and ferritin >200 ng/mL after 12 months of FCM initiation (P < 0.01). Haemoglobin (Hb) levels were maintained at >11 g/dL with a lower dose of darbepoetin throughout the follow-up. The sub-analysis of patients naïve to IV iron and with absolute or relative iron deficiency (n = 51) showed that 76.5% reached ferritin >200 ng/mL, 80.4% TSAT >20% and Hb increased (1.2 g/dL) after 4 months of FCM treatment (P < 0.01). Conclusion In this multicentre, retrospective, real-world study conducted in the PD population, FCM was effective, safe and easy to administer during routine clinical visits.

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Ferric Carboxymaltose

Cited by 11 publications

References 27 publications

Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside—a systematic review and meta‐analysis

Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside—a systematic review and meta‐analysis

Intravenous Iron Administration and Hypophosphatemia in Clinical Practice

Effectiveness and safety of ferric carboxymaltose therapy in peritoneal dialysis patients: an observational study

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