Ferric maltol

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Ferric maltol
Fe(maltate)3.svg
Clinical data
Trade names Feraccru, others
AHFS/Drugs.com Monograph
License data
Routes of
administration 		By mouth
Drug class Hematologic agent
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolism Glucuronidation (maltol)
Elimination half-life 0.7 hrs (maltol)
Excretion Urine (maltol)
Identifiers
  • Iron(3+) tris(2-methyl-4-oxo-4H-pyran-3-olate)
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
Formula C18H15FeO9
Molar mass 431.154 g·mol−1
3D model (JSmol)
  • CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].[Fe+3]
  • InChI=1S/3C6H6O3.Fe/c3*1-4-6(8)5(7)2-3-9-4;/h3*2-3,8H,1H3;/q;;;+3/p-3
  • Key:AHPWLYJHTFAWKI-UHFFFAOYSA-K

Ferric maltol, sold under the brand name Feraccru among others, is an iron containing medication for the treatment of people with low iron stores. [5] It is taken by mouth. [6] [8]

Contents

Medical uses

Ferric maltol is indicated for the treatment of iron deficiency. [5] [9]

Contraindications

Structure of Fe(maltol-H)3. Color code: red = O, gray = C, blue = Fe. GAVBEK.jpg
Structure of Fe(maltol-H)3. Color code: red = O, gray = C, blue = Fe.

Ferric maltol is contraindicated in people with hereditary hemochromatosis and other kinds of iron overload, as well as those repeatedly receiving blood transfusions. [11]

Side effects

The most common side effects are flatulence (in 5% of people taking the drug), diarrhea (4%), constipation (4%), stool color change (4%), nausea (3%), vomiting (3%), and abdominal discomfort, bloating and pain (1%). [6] [12] Ferric maltol may cause serious side effects including increased risk of inflammatory bowel disease flare and iron overload in the body. [6]

Interactions

No systematic interaction studies with ferric maltol have been conducted. Food reduces its uptake from the gut, as do calcium and magnesium salts and tetracycline antibiotics. Conversely, iron inhibits the uptake of many drugs, such as bisphosphonates, tetracycline antibiotics, quinolone antibiotics, levothyroxin, and levodopa. Combining the drug with intravenous iron can result in fast release of iron into the blood, potentially leading to low blood pressure or even collapse. [11]

Dimercaprol in combination with iron is toxic for the kidneys. The antibiotic chloramphenicol interferes with incorporation of iron into red blood cells and with iron excretion. Furthermore, iron can reduce the blood pressure lowering effects of methyldopa. [11]

Maltol is metabolized by the enzyme UGT1A6. It is not known whether inhibitors of this enzyme increase maltol concentrations in the body. [11]

Pharmacology

Mechanism of action

Ferric maltol acts as a source of iron, which is essential for oxygen transport in the blood and other processes in the human body. [13]

Pharmacokinetics

The substance is a complex of iron with maltol, which is absorbed from the gut and then dissociates, releasing iron and maltol separately into the bloodstream. Iron is bound to transferrin and reaches its highest concentrations in the blood plasma one to three hours after ingestion. It is also bound to ferritin for storage. Maltol reaches its highest plasma concentrations after 1 to 1.5 hours. It is quickly metabolized to the glucuronide by UGT1A6 and eliminated via the urine with a biological half-life of 0.7 hours. 40–60% are excreted in the glucuronidized form. [11] [12]

History

Ferric maltol was approved for medical use in the European Union in February 2016. [8]

Ferric maltol was approved for medical use in the United States in July 2019, [7] [14] based on evidence from three clinical trials (NCT01340872, NCT01352221, and NCT02968368). [6] All 295 participants had low iron stores in the body and consequent iron deficiency anemia. In the first two trials low iron was caused by participants' inflammatory bowel disease and in the last trial, by long standing (chronic) kidney disease. [6] Trials were conducted at 79 sites in Europe and the United States. [6]

The efficacy of ferric maltol to treat iron deficiency in people aged 10-17 years of age was assessed in the FORTIS trial (NCT05126901). [9] The trial treated 24 participants with age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at week 12. [9] This, on average, would be the expected increase in hemoglobin with one blood transfusion. [9]

References

  1. ↑ "Summary Basis of Decision for Accrufer". Drug and Health Products Portal. 2 January 2025. Retrieved 25 January 2025.
  2. ↑ "Accrufer product information". Health Canada . 21 August 2024. Retrieved 27 December 2024.
  3. ↑ "Regulatory Decision Summary for Accrufer". Drug and Health Products Portal. 21 August 2024. Retrieved 27 December 2024.
  4. ↑ "Feraccru 30mg hard capsules - Summary of Product Characteristics (SmPC)". electronic medicines compendium (emc). 7 February 2019. Archived from the original on 23 November 2019. Retrieved 23 November 2019.
  5. 1 2 3 "Accrufer- ferric maltol capsule". DailyMed. 6 December 2023. Retrieved 23 December 2025.
  6. 1 2 3 4 5 6 7 "Drug Trials Snapshots: Accrufer". U.S. Food and Drug Administration (FDA). 15 August 2019. Archived from the original on 23 November 2019. Retrieved 23 November 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. 1 2 "Drug Approval Package: Accrufer". U.S. Food and Drug Administration (FDA). 14 August 2019. Archived from the original on 23 November 2019. Retrieved 23 November 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  8. 1 2 3 "Feraccru EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 23 November 2019. Retrieved 23 November 2019. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. 1 2 3 4 "FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older". U.S. Food and Drug Administration (FDA). 22 December 2025. Retrieved 23 December 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  10. ↑ Ahmet MT, Frampton CS, Silver J (1988). "A Potential Iron Pharmaceutical Composition for the Treatment of Iron-Deficiency Anaemia. The Crystal and Molecular Structure of mer-tris-(3-Hydroxy-2-methyl-4H-pyran-4-onato)iron(III)". Journal of the Chemical Society, Dalton Transactions (5): 1159. doi:10.1039/DT9880001159.
  11. 1 2 3 4 5 "Feraccru: EPAR – Product Information" (PDF). European Medicines Agency. 25 February 2020. Archived (PDF) from the original on 11 April 2020. Retrieved 29 July 2020.
  12. 1 2 Ferric maltol Professional Drug Facts . Accessed 29 July 2020.
  13. ↑ Maton A, Hopkins J, McLaughlin CW, Johnson S, Warner MQ, LaHart D, et al. (1993). Human Biology and Health. Englewood Cliffs, New Jersey, US: Prentice Hall. ISBN   978-0139811760.
  14. ↑ "Accrufer (ferric maltol) FDA Approval History". Drugs.com. 25 July 2019. Archived from the original on 1 August 2019. Retrieved 23 November 2019.
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