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FERRIC MALTOL CAP,ORAL

Clinical Criteria Summary

Indication

  • Treatment of iron deficiency in adults

Patient Population & Clinical Context

  • Adults with iron deficiency anemia (IDA)
  • Specifically studied in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD) not on dialysis
  • Studied in patients intolerant or refractory to treatment with oral iron therapy

Dosing & Administration

  • 30 mg capsules
  • Recommended dose: 30 mg twice daily, taken one hour before or two hours after a meal
  • Capsules should not be opened for chewed
  • Separate administration from other oral medications by at least 4 hours if concomitant use may decrease bioavailability of iron or the other medication

Contraindications

  • Hypersensitivity to ferric maltol (reactions may include shock, clinically significant hypotension, loss of consciousness, and/or collapse)
  • Hemochromatosis and other iron overload syndromes
  • Receiving repeated blood transfusions

Warnings & Precautions

  • Increased risk of IBD flare: Avoid use in patients with active IBD flare due to potential risk for increased gastrointestinal inflammation
  • Iron overload: Excess iron storage and possibly iatrogenic hemosiderosis can occur with excessive therapy; assess iron parameters prior to treatment and monitor while on therapy; do not administer to patients with iron overload or those receiving IV iron
  • Risk of overdose in children due to accidental ingestion: Keep product out of reach of children; contact a doctor or poison control center immediately in case of accidental overdose

Place in Therapy & Formulary Criteria

  • Requires a prescription (non-formulary status)
  • Oral iron therapies available on the VA National Formulary should be used first for management of IDA where oral iron is indicated
  • Use may be determined on a case-by-case basis depending on patient-specific considerations including efficacy or tolerability to current available options, convenience, and cost
  • IV iron may be considered where oral iron therapy is ineffective or not tolerated, in selected patients with impaired absorption or ongoing blood loss, or in patients with IDA and CKD on dialysis

Source Documents