Ferric Maltol Brand Name– ACCRUFER
What is Ferric Maltol
Ferric maltol is an oral iron replacement therapy approved for iron-deficiency anemia in adults.
Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. Iron is an essential mineral and is a component of hemoglobin, myoglobin, and multiple enzymes.
The anemia of iron deficiency may result in fatigue, exertional shortness of breath, tachycardia, pallor, headache, glossitis, koilonychia (spoon nails), and decreased cognitive functioning.
The safety and efficacy of ferric maltol for the treatment of iron-deficiency anemia in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD) was established in 3 clinical studies.
In all studies, the primary efficacy outcome was the mean change in hemoglobin concentration from baseline to study end (least square (LS) mean difference) between ferric maltol and placebo. In patients with IBD, the LS mean difference was 2.18 g/dL at week 12. In patients with CKD, the LS mean difference was 0.52 g/dL at week 16.
The mean change in ferritin concentrations from baseline to study end was also significantly higher in ferric maltol-treated patients compared with placebo.
As with other iron supplements, gastrointestinal adverse effects are common with ferric maltol; however, it is recommended that ferric maltol be taken on an empty stomach to increase absorption.
Indications
- iron-deficiency anemia
For the treatment of iron-deficiency anemia
Side Effects
The most common adverse reactions reported in the placebo-controlled phase in clinical studies with ferric maltol (n = 175) were gastrointestinal in nature and included
- flatulence (4.6%)
- diarrhea (4%)
- constipation (4%)
- stool discoloration (4%)
- abdominal pain (2.9%)
- nausea (1.7%)
- vomiting (1.7%)
- abdominal discomfort (1.1%)
- abdominal distention (1.1%)
- The most common adverse reaction leading to therapy discontinuation of ferric maltol was abdominal pain (1.7% of patients)
Contraindications
- accidental exposure
- breast-feeding
- Crohn’s disease
- geriatric
- hemochromatosis
- hemosiderosis
- inflammatory bowel disease
- pregnancy
- ulcerative colitis
Interactions
No information is available regarding drug interactions associated with Ferric Maltol