Ferric Maltol

Approved Indications:

• Treatment of iron deficiency anemia (IDA) in adults and adolescents (≥10 years) when oral iron preparations are inadequate or not tolerated.
• Iron deficiency anemia associated with inflammatory bowel disease (IBD) such as Crohn’s disease and ulcerative colitis.
• Iron deficiency anemia due to malabsorption syndromes or chronic blood loss.
• Maintenance treatment of iron stores after correction of anemia.

Off-label/Clinically accepted uses:

• Iron deficiency anemia in patients intolerant to conventional oral iron salts.
• IDA in chronic diseases with poor oral iron absorption.

• Route: Oral administration.
• Adult and adolescent dose (≥10 years): 30 mg elemental iron (one capsule of 30 mg ferric maltol) taken twice daily.
• Duration: Typically 12 weeks, with extension or maintenance treatment as clinically indicated.
• Special populations:
• Elderly: No specific dosage adjustment, but monitor response and tolerance.
• Renal impairment: No dose adjustment required.
• Hepatic impairment: Use with caution; no specific dose adjustment data available.
• Administration tips: Should be taken on an empty stomach or between meals for optimal absorption; if gastrointestinal upset occurs, may be taken with food.
• Avoid concomitant intake with agents that impair iron absorption (e.g., antacids, calcium supplements) close to dosing time.

Ferric Maltol is a stable complex of ferric iron (Fe3+) and maltol, a naturally occurring sugar derivative. The complex protects iron from premature precipitation in the gastrointestinal tract, enhancing oral bioavailability. Once absorbed in the duodenum and proximal jejunum, ferric iron dissociates from maltol and enters the systemic circulation, where it binds transferrin and is transported to bone marrow and tissues for incorporation into hemoglobin and iron stores. The maltol moiety facilitates iron uptake and reduces free iron–mediated oxidative damage, improving gastrointestinal tolerability compared to conventional oral iron salts.

• Absorption: Oral ferric maltol is absorbed in the upper small intestine; iron absorption is enhanced due to the maltol ligand stabilizing iron in soluble form.
• Distribution: Iron binds to plasma transferrin and distributes primarily to bone marrow and reticuloendothelial system.
• Metabolism: Maltol is metabolized primarily via conjugation pathways; ferric iron enters iron pools.
• Elimination: Iron is incorporated into hemoglobin or stored; excess maltol and metabolites are excreted renally.
• Bioavailability: Enhanced compared to non-complexed ferric iron salts.
• Half-life: Iron homeostasis depends on physiological needs; maltol half-life is short (hours).
• Onset: Clinical improvement in hemoglobin may be seen after 2 to 4 weeks.

• Pregnancy: Limited human data; animal studies show no teratogenicity. Use only if potential benefit justifies potential risk.
• Lactation: Unknown if ferric maltol is excreted in human milk. Oral iron is generally considered compatible with breastfeeding. Use with caution.

• Primary class: Oral iron supplement
• Subclass: Ferric iron complex with maltol

• Known hypersensitivity to ferric maltol or any excipients.
• Iron overload conditions (e.g., hemochromatosis, hemosiderosis).
• Non-iron deficiency anemia.
• Acute or chronic infections with active systemic involvement.
• Use in children under 10 years due to insufficient safety data.

• Gastrointestinal disorders: May cause mild GI side effects; monitor for persistent abdominal pain or bleeding.
• Iron overload: Avoid use in patients with disorders of iron metabolism.
• Hypersensitivity: Rare allergic reactions reported; discontinue if symptoms develop.
• Monitoring: Regular monitoring of hemoglobin, ferritin, transferrin saturation (TSAT) recommended to assess response and avoid iron overload.
• Use in hepatic impairment: Caution advised.
• Patients with inflammatory bowel disease: Monitor disease activity, as iron can potentially exacerbate symptoms in some cases.

Common:

• Gastrointestinal: Diarrhea, nausea, abdominal pain, constipation, flatulence.
• Taste disturbance.
• Headache.

Serious but rare:

• Hypersensitivity reactions (rash, pruritus, anaphylaxis).
• Iron overload if used inappropriately.

• Antacids, calcium supplements, proton pump inhibitors: May reduce iron absorption; separate dosing by at least 2 hours.
• Tetracyclines and fluoroquinolones: Iron may reduce absorption and efficacy; separate dosing by at least 2 hours.
• Vitamin C: Can enhance iron absorption when co-administered.
• No significant interactions involving CYP450 enzymes.

• Recent guidelines emphasize the use of ferric maltol as an effective oral iron formulation with improved tolerability in IBD-associated iron deficiency anemia.
• Recommendations suggest ferric maltol as an alternative for patients intolerant to conventional oral ferrous salts.
• Monitoring phosphate levels is not generally required for oral iron preparations such as ferric maltol.
• No new black box warnings have been issued.

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Protect from moisture and light.
• Keep in original packaging until use.
• Keep out of reach of children.
• No refrigeration required.