Ferric pyrophosphate citrate for parenteral administration of maintenance iron: structure, mechanism of action, clinical efficacy and safety

References

• Sargent JA, Acchiardo SR. Iron requirements in hemodialysis. Blood Purif. 2004; 200422(1):112–123.
   PubMed Web of Science ®Google Scholar
• Babitt JL, Lin HY. Mechanisms of anemia in CKD. J Am Soc Nephrol. 2012;23(10):1631–1634.
   PubMed Web of Science ®Google Scholar
• KDIGO. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl. 2012;2(4):279–334.
   Google Scholar
• Wang C, Graham DJ, Kane RC, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA. 2015;314(19):2062–2068.
   PubMed Web of Science ®Google Scholar
• Rostoker G, Vaziri ND, Fishbane S. Iatrogenic iron overload in dialysis patients at the beginning of the 21st century. Drugs. 2016;76(7):741–757.
   PubMed Web of Science ®Google Scholar
• Rostoker G, Vaziri ND. Impact of iatrogenic iron overload on the course of hepatitis C in the dialysis population: a plea for caution. Hemodial Int. 2017;21 (Suppl 1):S68–S77.
   PubMed Web of Science ®Google Scholar
• Ganz T. Systemic iron homeostasis. Physiol Rev. 2013;93(4):1721–1741.
   PubMed Web of Science ®Google Scholar
• Paganini EP. Overview of anemia associated with chronic renal disease: primary and secondary mechanisms. Semin Nephrol. 1989;9(1 Suppl 1):3–8.
   PubMed Web of Science ®Google Scholar
• Wizemann V, Buddensiek P, de Boor J, et al. Gastrointestinal blood loss in patients undergoing maintenance dialysis. Kidney Int Suppl. 1983;16:S218–S20.
   PubMedGoogle Scholar
• Rosenblatt SG, Drake S, Fadem S, et al. Gastrointestinal blood loss in patients with chronic renal failure. Am J Kidney Dis. 1982;1(4):232–236.
   PubMed Web of Science ®Google Scholar
• Noris M, Remuzzi G. Uremic bleeding: closing the circle after 30 years of controversies? Blood. 1999;94(8):2569–2574.
   PubMed Web of Science ®Google Scholar
• Tsukamoto T, Matsubara T, Akashi Y, et al. Annual iron loss associated with hemodialysis. Am J Nephrol. 2016;43(1):32–38.
   PubMed Web of Science ®Google Scholar
• Ganz T. Erythropoietic regulators of iron metabolism. Free Radic Biol Med. 2019;133:69–74.
   PubMed Web of Science ®Google Scholar
• Ganz T, Nemeth E. Iron balance and the role of hepcidin in chronic kidney disease. Semin Nephrol. 2016;36(2):87–93.
   PubMed Web of Science ®Google Scholar
• Brătescu LO, Bârsan L, Gârneaţă L, et al. Effects of additional iron doses on hepcidin-25 level in hemodialysis patients without evident iron deficiency. Int Urol Nephrol. 2014;46(5):1005–1012.
   PubMed Web of Science ®Google Scholar
• Fishbane S, Spinowitz B. Update on anemia in ESRD and earlier stages of CKD: core curriculum 2018. Am J Kidney Dis. 2018;71(3):423–435.
   PubMed Web of Science ®Google Scholar
• Shirazian S, Grant C, Miller I, et al. How can erythropoeitin-stimulating agent use be reduced in chronic dialysis patients? The use of iron supplementation to reduce ESA dosing in hemodialysis. Semin Dial. 2013;26(5):534–536.
   PubMed Web of Science ®Google Scholar
• Grutzmacher P, Tsobanelis T, Roth P, et al. Effect of recombinant human erythropoietin on iron balance in maintenance hemodialysis: theoretical considerations, clinical experience and consequences. Clin Nephrol. 1992;38 (Suppl 1):S92–S97.
   PubMed Web of Science ®Google Scholar
• Plastina JCR, Obara VY, Barbosa DS, et al. Functional iron deficiency in patients on hemodialysis: prevalence, nutritional assessment, and biomarkers of oxidative stress and inflammation. Braz J Nephrol. 2019;41(4):472–480.
   Google Scholar
• Goodnough LT. Iron deficiency syndromes and iron-restricted erythropoiesis (CME). Transfusion. 2012;52(7):1584–1592.
   PubMed Web of Science ®Google Scholar
• Health ARCf. DOPPS practice monitor; 2020. Available from: https://www.dopps.org/DPM/Default.aspx.
   Google Scholar
• Rostoker G, Vaziri ND. Iatrogenic iron overload and its potential consequences in patients on hemodialysis. Presse Med. 2017;46(12 Pt 2):e312–e28.
   PubMed Web of Science ®Google Scholar
• Ashby DR, Gale DP, Busbridge M, et al. Plasma hepcidin levels are elevated but responsive to erythropoietin therapy in renal disease. Kidney Int. 2009;75(9):976–981.
   PubMed Web of Science ®Google Scholar
• Robiquet ME. Therapeutic employment of the pyrophosphate of iron. Am J Med Sci. 1857;34:215–217.
   Google Scholar
• Chapman EM. The history, preparation and theraeutical uses of the citro-ammoniacal pyrophosphate of iron, named in brief pyrophosphate of iron. Boston Med Surg J. 1862;66(1):9–12.
   Google Scholar
• Gupta A, Amin NB, Besarab A, et al. Dialysate iron therapy: infusion of soluble ferric pyrophosphate via the dialysate during hemodialysis. Kidney Int. 1999;55(5):1891–1898.
   PubMed Web of Science ®Google Scholar
• Gupta A, Pratt R, Mishra B. Physicochemical characterization of ferric pyrophosphate citrate. Biometals. 2018;31(6):1091–1099.
   PubMed Web of Science ®Google Scholar
• Gupta A, Crumbliss AL. Treatment of iron deficiency anemia: are monomeric iron compounds suitable for parenteral administration? J Lab Clin Med. 2000;136(5):371–378.
   PubMed Web of Science ®Google Scholar
• Pratt R, Handelman GJ, Edwards TE, et al. Ferric pyrophosphate citrate: interactions with transferrin. Biometals. 2018;31(6):1081–1089.
   PubMed Web of Science ®Google Scholar
• Edwards TE, Pratt R. Crystal structure of human transferrin bound to Triferic FPC iron pyrophosphate; 2018. Available from: https://www.rcsb.org/structure/6CTC.
   Google Scholar
• Noinaj N, Steere A, Mason AB, et al. The 2.1 angstrom crystal structure of diferric human transferrin; 2012. Available from: https://www.rcsb.org/structure/3V83.
   Google Scholar
• Pratt RD, Swinkels DW, Ikizler TA, et al. Pharmacokinetics of ferric pyrophosphate citrate, a novel iron salt, administered intravenously to healthy volunteers. J Clin Pharmacol. 2017;57(3):312–320.
   PubMed Web of Science ®Google Scholar
• Brissot P, Ropert M, Le LC, et al. Non-transferrin bound iron: a key role in iron overload and iron toxicity. Biochim Biophys Acta. 2012;1820(3):403–410.
   PubMed Web of Science ®Google Scholar
• Pratt RD, Grimberg S, Zaritsky JJ, et al. Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis. Pediatr Nephrol. 2018;33(11):2151–2159.
   PubMed Web of Science ®Google Scholar
• Fishbane SN, Singh AK, Cournoyer SH, et al. Ferric pyrophosphate citrate (triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015;30(12):2019–2026.
   PubMed Web of Science ®Google Scholar
• Gupta A, Lin V, Guss C, et al. Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients. Kidney Int. 2015;88(5):1187–1194.
   PubMed Web of Science ®Google Scholar
• Marbury T, van Heuveln F, van der Horst E, et al. Pharmacokinetics and safety of ferric pyrophosphate citrate intravenous: Equivalence to administration via dialysate. J Clin Pharmacol. 2021;62(5):681–688.
   Web of Science ®Google Scholar
• Pratt RD. Pharmacokinetics and pharmacodynamics of unfractionated heparin and FErric pyrophosphate citrate co-administration during hemodialysis: no drug-drug interaction. J Bioequivalence Bioavailab. 2021;13(S4):1–7.
   Google Scholar
• Hoffman M, Delvalle R, Pratt RD. Retrospective observational analysis of ferric pyrophosphate citrate (Triferic®) administered via dialysate. Experience at a Single Facility over 2 Years Archives of Clinical Nephrology. 2021;7(1):044–049.
   Google Scholar
• Shan Wang LD, Dhanani L, Malone B, et al. Institutional usage of ferric pyrophosphate citrate (FPC) delivered via dialysate in reducing erythropoiesis stimulating agents (ESAs) and IV iron cost. Hosp Pharm. 2022;57(3):355–358.
   PubMed Web of Science ®Google Scholar
• Szebeni J, Fishbane S, Hedenus M, et al. Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management. Br J Pharmacol. 2015;172(21):5025–5036.
   PubMed Web of Science ®Google Scholar
• Rampton D, Folkersen J, Fishbane S, et al. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014;99(11):1671–1676.
   PubMed Web of Science ®Google Scholar
• Wang C, Wong S, Graham DJ. Risk of anaphylaxis with intravenous iron products. JAMA. 2016;315(20):2232–2233.
   PubMed Web of Science ®Google Scholar
• Dave CV, Brittenham GM, Carson JL, et al. Risks for anaphylaxis with intravenous iron formulations: a retrospective cohort study. Ann Intern Med. 2022;175(5):656–664.
   PubMed Web of Science ®Google Scholar
• Wang H, Wang HS, Liu ZP. Agents that induce pseudo-allergic reaction. Drug Discov Ther. 2011;5(5):211–219.
   PubMedGoogle Scholar
• Moghimi SM. Nanomedicine safety in preclinical and clinical development: focus on idiosyncratic injection/infusion reactions. Drug Discov Today. 2018;23(5):1034–1042.
   PubMed Web of Science ®Google Scholar
• Szebeni J. Complement activation-related pseudoallergy: a stress reaction in blood triggered by nanomedicines and biologicals. Mol Immunol. 2014;61(2):163–173.
   PubMed Web of Science ®Google Scholar
• Macdougall IC, White C, Anker SD, et al. Intravenous iron in patients undergoing maintenance hemodialysis. N Engl J Med. 2019;380(5):447–458.
   PubMed Web of Science ®Google Scholar