Iron (as Ferric Maltol INN)

Ferric Maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. It has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT). Ferric Maltol is not absorbed systemically as an intact complex following oral administration, so maternal use is not expected to result in fetal exposure to the drug.

• Iron deficiency in adults

Adult Dose (Oral):

• Recommended dosage: 30 mg twice daily
• Take on empty stomach (at least 1 hour before or 2 hours after meals)
• Treatment duration: at least 12 weeks (until ferritin levels are normal)

Child Dose: Safety and effectiveness not established

Most Common Side Effects:

• Flatulence
• Diarrhea
• Constipation
• Feces discolored
• Abdominal pain
• Nausea
• Vomiting

Precautions:

• Avoid use in patients with an active inflammatory bowel disease (IBD) flare (potential risk of increased inflammation in GI tract)
• Do not administer to patients with evidence of iron overload or patients receiving intravenous iron
• Assess iron parameters prior to initiating therapy and monitor while on therapy
• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years

Contraindications:

• Known hypersensitivity to ferric maltol or any other components
• History of hemochromatosis and other iron overload syndromes
• Patients receiving repeated blood transfusions

Drug Interactions:

• Concomitant use with dimercaprol increases risk of nephrotoxicity (avoid)
• May decrease bioavailability of some drugs (mycophenolate, ethynyl estradiol, ciprofloxacin, doxycycline)
• For oral drugs where reduced bioavailability may cause clinically significant effects, separate administration by at least 4 hours

Use in Pregnancy: Ferric maltol is not absorbed systemically as an intact complex following oral administration; maternal use is not expected to result in fetal exposure.

Use in Lactation: No data on presence of ferric maltol in human milk, effects on breastfed child or effects on milk production; breastfeeding is not expected to result in exposure of child to ferric maltol.

Overdose: Early signs and symptoms: nausea, vomiting, abdominal pain, diarrhea; serious cases: hypoperfusion, metabolic acidosis, systemic toxicity; dosages exceeding iron needs may lead to hemosiderosis.