ferric maltol (Rx)

Brand and Other Names:Accrufer
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 30mg

Iron Deficiency

An iron replacement product indicated for iron deficiency

30 mg PO BID

Continue as long as necessary until ferritin levels are within the normal range

Treatment duration depends on severity of iron deficiency but generally at least 12 weeks of treatment is required

Safety and efficacy not established

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Interactions

Interaction Checker

and ferric maltol

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            Adverse Effects

            1-10%

            Flatulence (4.6%)

            Diarrhea (4%)

            Constipation (4%)

            Discolored feces (4%)

            Abdominal pain (2.9%)

            Nausea (1.7%)

            Vomiting (1.7%)

            Abdominal pain (1.7%)

            Abdominal discomfort (1.1%)

            Abdominal distension (1.1%)

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            Warnings

            Contraindications

            Hypersensitivity to active substance or to any of the excipients

            Hemochromatosis and other iron overload syndromes

            Patients receiving repeated blood transfusions

            Cautions

            Avoid use in patients with an active inflammatory bowel disease flare, as there is potential risk of increased inflammation in the gastrointestinal tract

            Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children ages ≤6 years; keep this product out of reach of children

            Iron overload

            • Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis; do not administer to patients with evidence of iron overload or patients receiving IV iron
            • Assess iron parameters before initiating treatment and monitor during therapy

            Drug interaction overview

            • Oral medications
              • There are no empirical data on avoiding drug interactions between ferric maltol and concomitant oral medication
              • Concomitant use of some oral drugs may reduce bioavailability of iron after ferric maltol administration
              • Separate the administration of ferric maltol from these drugs; duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate- or extended-release product; monitor clinical response to ferric maltol
              • Coadministration of ferric maltol with some oral medications may also decrease the bioavailability of some drugs
              • For oral drugs for which reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate ferric maltol administration by at least 4 hr; monitor clinical responses to concomitant drugs as appropriate
            • Dimercaprol
              • Coadministration of iron products with dimercaprol may increase the risk of nephrotoxicity
              • Avoid use with dimercaprol
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            Pregnancy & Lactation

            Pregnancy

            Not absorbed systemically as an intact complex following oral administration

            Maternal use is not expected to result in fetal exposure to the drug

            Animal data

            • In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar rats during organogenesis at doses 13-32 times the recommended human dose resulted in no adverse developmental outcomes
            • Overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes, and fetal malformation

            Clinical considerations

            • 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

            Lactation

            There are no data on the presence of ferric maltol in human milk, the effects on the breastfed child, or the effects on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Nonsalt, oral formulation of ferric iron

            Supplements iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin

            Delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin

            Absorption

            Dissociates upon uptake from gastrointestinal tract, allowing iron and maltol to be absorbed separately

            Peak plasma time: 1.5-3 hr

            Effect of food

            • Food shown to decrease bioavailability of iron after administration of ferric maltol

            Metabolism

            Maltol is metabolized through glucuronidation (UGT1A6) and sulphation in vitro

            Elimination

            Excretion (maltol): Urine (39.8-60%; as maltol glucuronide)

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            Administration

            Oral Administration

            Take 1 hr before or 2 hr after a meal

            Do not open, break, or chew capsules

            Storage

            Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.