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INDICATIONS AND USAGE

ACCRUFeR® (ferric maltol) is indicated for the treatment of iron deficiency in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ACCRUFeR is contraindicated in patients with a history of:

Hypersensitivity to ACCRUFeR or any of its inactive components
Hemochromatosis and other iron overload syndromes
Receiving repeated blood transfusions as this may result in iron overload

WARNINGS AND PRECAUTIONS

Increased Risk of Inflammatory Bowel Disease (IBD) Flares

Avoid use of ACCRUFeR in patients with an active IBD flare, as there is potential risk of increased inflammation in the gastrointestinal tract.

Iron Overload

Excessive 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. Assess iron parameters prior to initiating ACCRUFeR and monitor iron parameters while on therapy.

Risk of Overdosage in Children Due to Accidental Ingestion

Accidental overdose of iron products is a leading cause of fatal poisoning in children under age 6. Keep out of reach of children.

ADVERSE REACTIONS

Most common adverse reactions (≥1%) reported with ACCRUFeR during the double-blind, placebo-controlled portions of the pivotal trials were flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting, and abdominal discomfort/distension.

To report adverse events, please contact Shield Therapeutics at 1-888-963-6267. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

DRUG INTERACTIONS

Avoid concomitant use with dimercaprol
Separate administration of ACCRUFeR from certain oral medications where interaction might occur. Monitor clinical responses as appropriate

Please see ACCRUFeR full Prescribing Information.