Accrufer
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Accrufer Prescribing Information
ACCRUFER is indicated for the treatment of iron deficiency in adults.
Capsules: ACCRUFER contains 30 mg iron, as ferric maltol, in red capsules printed with “30”.
ACCRUFER is contraindicated in patients with a history of:
- Hypersensitivity to the active substance or to any of the excipients[see Description (. Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse.)]
11 DESCRIPTIONACCRUFER (ferric maltol) capsules, an iron replacement product for oral administration, contain 30 mg iron and 201.5 mg maltol. Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. Ferric maltol is 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1) and has the molecular formula (C6H5O3)3Fe and a molecular mass of 431.2.
Each red capsule, printed with “30”, contains colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate and sodium lauryl sulfate as inactive ingredients. In addition, the capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No.6, hypromellose and titanium dioxide. The ink used for printing the marking contains ammonium hydroxide, ethanol, iron oxide black and propylene glycol.
Image 1 - Hemochromatosis and other iron overload syndromes[see Warnings and Precautions (. Use may result in iron overdose)]
5.1 Increased Risk of Inflammatory Bowel Disease (IBD) FlareAvoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.
[see Overdosage ()].10 OVERDOSAGENo data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity.
Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. Do not administer ACCRUFER to patients with iron overload
[see Contraindications]. - Receiving repeated blood transfusions. Use may result in iron overload[see Warnings and Precautions () and Overdosage (
5.2 Iron OverloadExcessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron
[see Contraindications]. Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy[see Overdosage and Clinical Pharmacology ].)].10 OVERDOSAGENo data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity.
Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. Do not administer ACCRUFER to patients with iron overload
[see Contraindications].
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Increased Risk of Inflammatory Bowel Disease Flare[see Warnings and Precautions ()]
5.1 Increased Risk of Inflammatory Bowel Disease (IBD) FlareAvoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.
- Iron Overload[see Warnings and Precautions ()]
5.2 Iron OverloadExcessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron
[see Contraindications]. Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy[see Overdosage and Clinical Pharmacology ].
ACCRUFER (ferric maltol) capsules, an iron replacement product for oral administration, contain 30 mg iron and 201.5 mg maltol. Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. Ferric maltol is 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1) and has the molecular formula (C
6H
5O
3)
3Fe and a molecular mass of 431.2.
Each red capsule, printed with “30”, contains colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate and sodium lauryl sulfate as inactive ingredients. In addition, the capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No.6, hypromellose and titanium dioxide. The ink used for printing the marking contains ammonium hydroxide, ethanol, iron oxide black and propylene glycol.