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Review
. 2025 Jul 9;14(14):4861.
doi: 10.3390/jcm14144861.

Evaluating the Risk of Hypophosphatemia with Ferric Carboxymaltose and the Recommended Approaches for Management: A Consensus Statement

Affiliations
Review

Evaluating the Risk of Hypophosphatemia with Ferric Carboxymaltose and the Recommended Approaches for Management: A Consensus Statement

Giuseppe Rosano et al. J Clin Med. .

Abstract

Background/Objectives: The development of hypophosphatemia has been associated with intravenous iron products, with the rate of hypophosphatemia found to be higher with ferric carboxymaltose. This consensus statement provides clinical guidance on the risk of hypophosphatemia development with ferric carboxymaltose and the approaches for management. To develop consensus recommendations regarding the clinical implications of hypophosphatemia after the administration of ferric carboxymaltose, the assessment of patient risk profile, and recommended approaches for risk reduction. Methods: Consensus statements were developed from an in-person meeting of specialists with expertise in iron pathophysiology and iron therapy and further supplemented with literature review. The multidisciplinary expert panel comprised global iron specialists spanning anesthesiology, cardiology, gastroenterology, obstetrics/gynecology, hematology, nephrology, and iron molecular biology. Structured discussions were held in an in-person meeting to gather expert opinion on the evidence base regarding intravenous iron and hypophosphatemia. Consolidated summary opinions underwent further iterations of panel review to form consensus recommendation statements. Results: The expert panel developed the following consensus statements: (1) Routine serum phosphate level measurement is not recommended for low-risk patients before or after treatment with ferric carboxymaltose, as most cases of hypophosphatemia that occur following the administration of ferric carboxymaltose are asymptomatic and transient; (2) patients receiving ferric carboxymaltose should be assessed for the degree of risk for developing symptomatic or severe hypophosphatemia prior to administration; (3) monitoring serum phosphate is recommended for patients at an increased risk for developing low serum phosphate or who require repeated courses of ferric carboxymaltose treatment at higher doses; (4) prophylactic oral phosphorus after ferric carboxymaltose is unlikely to effectively elevate phosphate and is not recommended for routine clinical practice; and (5) hypophosphatemic osteomalacia is rare and the risk of development after the administration of ferric carboxymaltose, in particular single infusion, is low. Conclusions: Hypophosphatemia following ferric carboxymaltose is predominantly asymptomatic and transient. Individuals at higher risk for developing hypophosphatemia with ferric carboxymaltose treatment include those who receive multiple infusions, higher cumulative doses, or long-term iron treatment or who have underlying clinical risk factors. These consensus statements provide structured guidance on the risk of hypophosphatemia with ferric carboxymaltose and the approaches to clinical management.

Keywords: ferric carboxymaltose; hypophosphatemia; iron; iron deficiency anemia; phosphate.

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Conflict of interest statement

G.R. has received honoraria and consulting fees from Alnylam, Astra Zeneca, Bayer, Boehringer Ingelheim, Cipla, CSL Vifor, Medronic, Servier, and Viatris. J.E. has received honoraria and grants from Amgen, Bayer, American Regent, Merck, Otsuka, Novo Nordisk, Applied Therapeutics, Cardurion, CSL Vifor, AstraZeneca, BI-Lilly, and US2.ai. E.N. has received consulting fees from Disc Medicine, Ionis Pharmaceuticals, Intrinsic Life Sciences, Chugai, CSL Vifor, and Novo Nordisk. P.P. has received honoraria and consulting fees from Boehringer Ingelheim, AstraZeneca, CSL Vifor, Servier, Novartis, Berlin Chemie, Bayer, Abbott Vascular, NovoNordisk, Pharmacosmos, WhiteSwell, Relaxera, and Radcliffe Group and has received research grants from CSL Vifor. M.R. has received honoraria from Alexion, CSL Vifor, and UCB. M.S. has received honoraria and/or research support from AMAG Pharmaceuticals, American Regent, Daiichi-Sankyo, Luitpold Pharmaceuticals, Pharmacosmos, and CSL Vifor; is a stockholder of AbbVie Inc., Abbott Laboratories, Bristol-Myers Squibb, Eli Lilly, Merck, and Pfizer; and is a stockholder and director of Periodic Products. D.R.S. has received honoraria and consulting fees from Alexion, AstraZeneca, Baxter, B. Braun Melsungen, CSL Behring, CSL Vifor, Celgene, Daiichi Sankyo, Haemonetics, iSEP, Novo Nordisk, Octapharma, Pharmacosmos, Pierre Fabre Pharma, Portola Schweiz, Roche Diagnostics, Shire, Werfen, and Zuellig. J.S. has received honoraria from AbbVie, CSL Vifor, Schär, Falk, Ferring, Fresenius Kabi, Immundiagnostik, Janssen, Medice, Pfizer, Pharmacosmos, Shield, Shire, Takeda, and Thermo Fisher and has board memberships with AbbVie, CSL Vifor Schär, Ferring, Fresenius Kabi, Immundiagnostik, Janssen, NPS Pharmaceuticals, Pharmacosmos, Shield, and Takeda. J.W. has received honoraria from Akebia, Calliditas, and CSL Vifor. R.J.M. has received honoraria and/or research support from American Regent, CSL Vifor, and Pharmacosmos.

Figures

Figure 1
Figure 1
Approach to evaluating the risk of hypophosphatemia for patients treated with ferric carboxymaltose. * Symptoms include fatigue, myalgia, and bone pain. FCM, ferric carboxymaltose; HP, hypophosphatemia.

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