Ferric maltol

What is Ferric maltol?

Ferric maltol (ACCRUFER) is an iron replacement product indicated for the treatment of iron deficiency in adults.

What are the uses of this medicine?

• This medicine is used for the treatment of iron deficiency in adults.

How does this medicine work?

• ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to the active substance or to any of the excipients
• Hemochromatosis and other iron overload syndromes
• Receiving repeated blood transfusions

What drug interactions can this medicine cause?

• Concomitant use of some drugs may reduce the bioavailability of iron after administration of ACCRUFER. Separate the administration of ACCRUFER from these drugs.
• Avoid concomitant use of ACCRUFER with dimercaprol.
• Concomitant use of ACCRUFER may decrease the bioavailability of some drugs. Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate.
• Some medicines may need to be taken at least 4 hours before or 4 hours after you have taken your ACCRUFER dose. Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended dosage of ACCRUFER is 30 mg twice daily, taken 1 hour before or 2 hours after a meal.

Administration

• Take ACCRUFER exactly as your healthcare provider tells you to.
• Take ACCRUFER 2 times a day on an empty stomach 1 hour before or 2 hours after meals.
• Swallow ACCRUFER capsules whole. Do not open, break, or chew ACCRUFER capsules.
• In case of accidental overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 30 mg

This medicine is available in fallowing brand namesː

• ACCRUFER

What side effects can this medication cause?

The most common side effects of this medicine include:

• flatulence
• diarrhea
• constipation
• feces discolored
• abdominal pain
• nausea
• vomiting
• abdominal discomfort/distension

ACCRUFER may cause serious side effects, including:

• Increased risk of inflammatory bowel disease (IBD) flare
• Too much iron stored in your body (iron overload)
• Risk of overdose in children due to accidental swallowing

What special precautions should I follow?

• Avoid 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.
• 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.
• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• It is not known if ACCRUFER will harm your unborn baby.
• An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.

Can this medicine be used in children?

• Safety and effectiveness of ACCRUFER have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: ferric maltol Inactive ingredients: Capsule: colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate, sodium lauryl sulfate Capsule Shell: FD&C Blue No. 1 FD&C Red No. 40, FD&C Yellow 6, hypromellose, titanium dioxide. Ink: ammonium hydroxide, ethanol, iron oxide black, propylene glycol

Who manufactures and distributes this medicine?

• Distributed by Shield Therapeutics Inc

What should I know about storage and disposal of this medication?

• Store ACCRUFER at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep ACCRUFER and all medicines out of reach of children.

• Dailymed label info on Ferric maltol
• FDA Ferric maltol