What is the recommended dosing regimen for Ferreluc (ferric maltol) in the treatment of iron deficiency anemia?

Ferric Maltol (Ferreluc) Dosing for Iron Deficiency Anemia

The recommended dose of ferric maltol is 30 mg twice daily (one tablet in the morning and one in the evening), taken on an empty stomach for optimal absorption. 1

Standard Dosing Regimen

• Ferric maltol 30 mg tablets should be administered twice daily, providing a total daily dose of 60 mg elemental iron 1
• Each 30 mg tablet contains 30 mg of elemental iron, making the dosing straightforward without complex calculations 1
• Treatment duration typically extends for 12 weeks initially to normalize hemoglobin in patients with moderate iron deficiency anemia (Hb >95 g/L), achieving normalization in 63-66% of cases 1
• For sustained benefit, treatment can be continued for up to 52 weeks, with hemoglobin normalization rates reaching 89% with prolonged therapy 1, 2

Administration Considerations

• Take on an empty stomach (at least 1 hour before or 2 hours after meals) to maximize iron absorption, as food can significantly reduce bioavailability 3
• The medication demonstrates rapid absorption with peak plasma concentrations occurring 1.0-1.5 hours post-dose 3
• No accumulation occurs with twice-daily dosing over extended periods, making it safe for long-term use 3

Clinical Context and Patient Selection

Ferric maltol is particularly appropriate for:

• Patients with inflammatory bowel disease who have inactive or moderately active disease and previous intolerance to traditional iron salts 1
• Patients with mild anemia (Hb 11.0-11.9 g/dL in women, 11.0-12.9 g/dL in men) whose disease is clinically inactive 1
• Patients with chronic kidney disease (stages 3-4) who have iron deficiency anemia and can tolerate oral therapy 1, 2
• Patients who prefer oral therapy over intravenous iron or when IV access is problematic 4

Monitoring Response

• Check hemoglobin at 2 weeks: An increase of at least 10 g/L (1.0 g/dL) strongly predicts subsequent treatment success 1
• Assess full response at 12 weeks: Expect a hemoglobin increase of at least 2 g/dL or normalization as an acceptable response 1
• Monitor iron indices at 3-month intervals during the first year, including ferritin and transferrin saturation 5
• Mean hemoglobin increases of 2.5 g/dL at 12 weeks and 2.7-2.9 g/dL at 24-52 weeks are typical with ferric maltol 4

Important Caveats

Gastrointestinal side effects occur in approximately 41-59% of patients, though most are mild to moderate 2, 4. These include:

• Abdominal discomfort, nausea, constipation, or diarrhea 2
• Treatment discontinuation due to adverse events occurs in 6-10% of patients 2, 4

Slower iron loading compared to IV iron: Ferric maltol has a relatively low iron content per dose (30 mg vs. 200-1000 mg with IV preparations), resulting in slower hemoglobin recovery 1. At 12 weeks, response rates are lower than IV ferric carboxymaltose (67% vs 84%), though long-term outcomes at 52 weeks are comparable 4.

Not first-line in specific situations where IV iron is preferred 1:

• Clinically active inflammatory bowel disease with impaired absorption
• Hemoglobin below 10 g/dL requiring rapid correction
• Previous documented intolerance to oral iron preparations
• Patients requiring erythropoiesis-stimulating agents

Cost consideration: Ferric maltol is significantly more expensive than traditional iron salts (approximately £47.60 vs £1.00-2.58 per 28 days) but considerably less expensive than parenteral iron preparations 1