Version May 2024
Note: Dosage expression: Dose is expressed in terms of elemental iron; the strength of each capsule represents the amount of elemental iron (ie, a 30 mg capsule contains 30 mg of elemental iron). Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, chronic kidney disease, active inflammatory bowel disease, cancer, or chronic or extensive blood loss) (Auerbach 2021).
Iron deficiency or iron-deficiency anemia, treatment:
Oral: 30 mg of elemental iron twice daily (manufacturer's labeling); some experts prefer 30 to 60 mg of elemental iron once every other day or on Monday, Wednesday, and Friday (Auerbach 2021; Stoffel 2017; Stoffel 2020). Note: Daily dosing has been shown to result in decreased absorption but may be reasonable in some individuals to improve adherence (Stoffel 2017; Stoffel 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely since there are no clinically meaningful changes in exposure of maltol or maltol glucuronide in subjects with nondialysis dependent chronic kidney disease.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Flatulence (5%), constipation (4%), diarrhea (4%), fecal discoloration (4%), abdominal pain (3%), nausea (2%), vomiting (2%), abdominal distention (1%), abdominal distress (1%)
Hypersensitivity to ferric maltol or any component of the formulation; hemochromatosis and other iron overload syndromes; patients receiving repeated blood transfusions.
Concerns related to adverse effects:
• Iron overload: Excessive iron therapy can lead to iron overload and possibly iatrogenic hemosiderosis. Assess iron parameters prior to and during therapy; do not use in patients with iron overload or receiving IV iron therapy.
Disease-related concerns:
• Inflammatory bowel disease: Avoid use in patients with an active inflammatory bowel disease flare; may increase risk of GI tract inflammation.
Concurrent drug therapy issues:
• Altered medication absorption: May affect absorption of other medications. The manufacturer's labeling recommends separating the administration of ferric maltol and other oral medications where reductions in bioavailability may affect safety and effectiveness by ≥4 hours.
Special populations:
• Older adult: Anemia in elderly patients is often caused by "anemia of chronic disease" or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the "anemia of chronic disease" is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.
• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.
Dosage form specific issues:
• Oral iron formulations: Immediate-release oral iron products are preferred for treatment of iron deficiency anemia; enteric-coated and slow/sustained-release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012).
Other warnings/precautions:
• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
ACCRUFeR: 30 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]
No
Capsules (ACCRUFeR Oral)
30 mg (per each): $11.25
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer ≥1 hour before or 2 hours after a meal. Swallow whole; do not open, break, or chew.
Iron deficiency or iron-deficiency anemia: Treatment of iron deficiency in adults.
Ferric maltol may be confused with ferric citrate, ferric carboxymaltose, ferric gluconate, ferric pyrophosphate citrate
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpha-Lipoic Acid: Iron Preparations may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Preparations. Management: Separate administration of alpha-lipoic acid from that of any iron-containing compounds by several hours. If alpha-lipoic acid is given 30 minutes before breakfast, then administer oral iron-containing products at lunch or dinner. Risk D: Consider therapy modification
Antacids: May decrease the absorption of Iron Preparations. Management: No action is likely necessary for the majority of patients who only use antacids intermittently or occasionally. Consider separating doses of oral iron and antacids in patients who require chronic use of both agents and monitor for reduced iron efficacy. Risk D: Consider therapy modification
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Iron Preparations may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron preparations under fed conditions, but coadministration with or 2 hours after an iron preparation is not recommended under fasting conditions. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Cefdinir: Iron Preparations may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop when combined. Risk D: Consider therapy modification
Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Dolutegravir: Iron Preparations may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Risk D: Consider therapy modification
Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification
Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification
Entacapone: Iron Preparations may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Ethinyl Estradiol-Containing Products: Ferric Maltol may decrease the serum concentration of Ethinyl Estradiol-Containing Products. Management: Ferric maltol labeling recommends separating administration of ethinyl estradiol-containing products from ferric maltol by at least four hours to minimize the potential for any interaction. Risk D: Consider therapy modification
Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Preparations. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron preparations. Therapy with oral iron preparations should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Risk D: Consider therapy modification
Levodopa: Iron Preparations may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Levothyroxine: Iron Preparations may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron preparations and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron preparations or levothyroxine. Risk D: Consider therapy modification
Methyldopa: Iron Preparations may decrease the serum concentration of Methyldopa. Management: Consider separating doses of methyldopa and orally administered iron preparation by 2 or more hours. Monitor for decreased efficacy of methyldopa if an oral iron preparation is initiated/dose increase, or increased efficacy if discontinued/dose decreased. Risk D: Consider therapy modification
PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification
Phosphate Supplements: Iron Preparations may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron preparation as possible to minimize the significance of this interaction. Risk D: Consider therapy modification
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Iron Preparations. Management: Give oral iron products at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
Quinolones: Iron Preparations may decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification
Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Risk D: Consider therapy modification
Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: Consider therapy modification
Tetracyclines: May decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification
Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination
Food decreases absorption of iron from ferric maltol. Management: Administer at least 1 hour before or 2 hours after a meal.
Iron and maltol are absorbed separately following maternal ingestion; the fetus is not expected to be exposed to the ferric maltol complex.
Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron-deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters; however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Siu 2015]). Use of low-dose supplemental iron is recommended for all pregnant patients beginning in the first trimester or first prenatal visit to prevent anemia at term (ACOG 2021).
Ferrous salts are preferred over ferric salts for the oral management of IDA in pregnancy due to better absorption and bioavailability (BSH [Pavord 2020]). Iron supplementation is recommended for 3 months once hemoglobin is within the normal range, and at least 6 weeks postpartum to replenish maternal iron stores (BSH [Pavord 2020]; FIGO 2019). Iron supplementation is recommended in addition to use of prenatal vitamins in pregnant patients diagnosed with IDA (ACOG 2021). Enteric-coated and slow/sustained-release preparations may be less effective due to decreased absorption, and use should be avoided (ACOG 2021; BSH [Pavord 2020]).
Iron is present in breast milk.
Iron and maltol are absorbed separately following maternal ingestion; a breastfed infant is not expected to be exposed to the ferric maltol complex.
Endogenous iron concentrations in breast milk vary by postpartum age and are lower than concentrations in the maternal plasma (Dorea 2000; Emmett 1997). Breast milk concentrations of iron are maintained in lactating patients with mild to moderate iron-deficiency anemia (IDA), but concentrations decrease if IDA is moderate to severe (El-Farrash 2012) or severe (Kumar 2008).
Iron deficiency and IDA are associated with adverse effects in postpartum patients (eg, altered cognition, depression, fatigue) that may influence interactions with the infant. Iron supplementation in the postpartum patient should be initiated as soon as possible following delivery when gestational anemia is a concern (WHO 2016).
All postpartum patients at risk of gestational anemia (regardless of breastfeeding status) may be given oral iron with or without folic acid for 6 to 12 weeks postpartum to reduce the risk of anemia (WHO 2016). Oral iron therapy is recommended for postpartum patients with uncorrected anemia at delivery who are hemodynamically stable and are asymptomatic or have only mild symptoms; treatment should continue for at least 3 months (BSH [Pavord 2020]). A product containing a ferrous salt may be preferred (WHO 2016).
Hemoglobin and hematocrit; consider additional tests such as RBC count, RBC indices, serum ferritin, transferrin saturation, total iron-binding capacity, serum iron concentration, and erythrocyte protoporphyrin concentration (CDC 1998).
Anemia:
Hemoglobin, whole blood:
Female: 12 to 16 g/dL (SI: 120 to 160 g/L) (ABIM 2023).
Male: 13 to 18 g/dL (SI: 120 to 180 g/L) (ABIM 2023; WHO 2011).
Iron deficiency:
Ferritin, serum: Note: Ferritin is an acute phase reactant; levels may be elevated in the presence of inflammation or infection which is independent of iron status (WHO 2020).
Female: 24 to 307 ng/mL (SI: 53.9 to 689.8 picomole/L).
Males: 24 to 336 ng/mL (SI: 53.9 to 755 picomole/L).
Iron, serum: 50 to 150 mcg/dL (SI: 9 to 26.9 micromole/L).
Total iron binding capacity, serum: 250 to 310 mcg/dL (SI: 44.8 to 55.5 micromole/L).
Transferrin saturation: 20% to 50%.
Transferrin, serum: 200 to 400 mg/dL (SI: 24.6 to 49.2 micromole/L).
Chronic kidney disease-associated anemia: To achieve and maintain target hemoglobin for patients with nondialysis-dependent chronic kidney disease, patients with a transferrin saturation (TSAT) ≤30% and a serum ferritin ≤500 ng/mL (SI: 1,123.5 picomole/L) will often respond to iron supplementation (Gutiérrez 2021; KDIGO 2012).
Ferric maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. Replaces iron, found in hemoglobin, myoglobin, and other enzymes; allows the transportation of oxygen via hemoglobin.
Absorption: Ferric maltol dissociates upon uptake from the GI tract; iron and maltol are absorbed separately.
Metabolism: Maltol: Rapidly conjugated with glucuronic acid.
Time to peak: Iron: 1.5 to 3 hours.
Excretion: Maltol: Urine (~40% to 60% as maltol glucuronide).
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