Accrufer (ferric maltol)

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What is Accrufer (ferric maltol) for?

Accrufer (ferric maltol) is a non-salt based oral iron replacement product indicated for the treatment of adults with low iron stores (iron deficiency) with or without anemia.^[1]

It is available in vial form containing 30 mg ferric maltol.^[1]

How does Accrufer (ferric maltol) work?

Iron deficiency is the most common nutritional disorder in the world. Ferric maltol delivers iron for uptake across the wall of the intestines and for transfer to transferrin and ferritin. Iron is essential for oxygen transport in the blood via hemoglobin and other processes in the human body.^[1]

Once it is ingested, ferric maltol breaks down in the gastrointestinal tract, and iron and maltol are absorbed separately. Ferric maltol replaces iron that is found in hemoglobin, myoglobin, and other enzymes, and maltol is broken down and eliminated out of the body.^[1]

Where has Accrufer (ferric maltol) been approved?

Accrufer (ferric maltol) was approved for the treatment of iron deficiency in adult patients with or without anemia by:

• The Food and Drug Administration (FDA), USA, on July 26, 2019.^[2]
• The European Medicines Agency (EMA), EU, on February 18, 2016, under the brand name Feraccru (ferric maltol).^[3]
• Swissmed, Switzerland, on April 24, 2019, under the brand name Feraccru (ferric maltol).^[4]

Accrufer (ferric maltol) is the first oral treatment option for patients with iron deficiency who are intolerant of or unwilling to take salt-based oral iron containing products, and an alternative to intravenous iron therapy.^[2]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Accrufer (ferric maltol) taken?

The standard dosage is:^[1]

• One Accrufer (ferric maltol) 30 mg capsule taken twice daily on an empty stomach.

Accrufer capsules should be taken 1 hour before or 2 hours after a meal. Do not open, break, or chew on the capsules.^[1]

Duration of treatment will depend on the severity of iron deficiency, but at least 12 weeks of treatment is required generally. Treatment should be continued as long as necessary until ferritin levels are within the normal range.^[1]

Complete information about Accrufer (ferric maltol) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Accrufer (ferric maltol)?

Common adverse reactions

The most common adverse reactions (1-10% of patients) listed in the prescribing information include:^[1]

• Flatulence
• Constipation
• Diarrhea
• Fecal discoloration
• Abdominal pain
• Nausea
• Vomiting
• Abdominal distention
• Abdominal distress

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Iron overload: excessive therapy with iron products can lead to excess storage of iron.
• Increased risk of active inflammatory bowel disease (IBD) flare.

Use in a specific population

It is not yet known if Accrufer (ferric maltol) is fatal for a fetus. Accrufer is not absorbed in the blood as an intact complex after oral administration, and it is not expected that a fetus will be exposed to the drug.^[1]

Maternal iron requirements increase during pregnancy. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Accrufer (ferric maltol) [PDF]
Shield Therapeutics plc, July 2019

2. FDA approves Feraccru® with a broad label of treating iron deficiency in adults [PDF]
Shield Therapeutics press release, July 26, 2019

3. Ferracru (ferric maltol)
European Medicines Agency, last checked on Aug 27, 2020

4. Swissmedic approves Feraccru® to treat Iron Deficiency with or without anaemia in adults [PDF]
Shield Therapeutics press release, April 24, 2019