ACCRUFER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ACCRUFER (ACCRUFER).
ACCRUFER (ferric maltol) is an oral iron replacement therapy. Ferric iron is complexed with maltol, which enhances absorption. Once absorbed, iron is utilized for hemoglobin synthesis and erythropoiesis.
| Metabolism | Iron is not metabolized; absorbed and incorporated into hemoglobin or stored as ferritin/hemosiderin. |
| Excretion | Renal 65% (as unchanged drug), fecal 35% |
| Half-life | 20 hours (prolonged in hepatic impairment) |
| Protein binding | 90% (transferrin) |
| Volume of Distribution | 10 L (0.14 L/kg in adults); indicates limited extravascular distribution |
| Bioavailability | Oral: 10-15%; IV: 100% |
| Onset of Action | Oral: 4-6 weeks for hemoglobin response; IV: 24-48 hours for reticulocytosis |
| Duration of Action | Up to 4 weeks for hemoglobin correction; iron stores replenished over 2-3 months |
170 mg (1 tablet) orally twice daily (340 mg total daily dose) for adults with iron deficiency anemia, taken on an empty stomach at least 1 hour before or 2 hours after meals.
| Dosage form | CAPSULE |
| Renal impairment | No dosage adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). Not studied in severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis, use with caution. |
| Liver impairment | Not studied in hepatic impairment; no specific Child-Pugh based recommendations available. Use with caution in severe hepatic impairment. |
| Pediatric use | Not approved for pediatric patients under 18 years of age due to lack of safety and efficacy data. |
| Geriatric use | No specific dose adjustments recommended for elderly patients; dosing follows adult guidelines. Monitor for gastrointestinal adverse events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ACCRUFER (ACCRUFER).
| Breastfeeding | Ferric carboxymaltose is excreted into breast milk in small amounts. The M/P ratio is not established. The low molecular weight iron complex is unlikely to cause adverse effects in the breastfed infant. Iron supplementation in lactating women is considered safe, as levels in milk are tightly regulated and unlikely to exceed daily requirements. Caution is advised if the infant has iron overload disorders. |
| Teratogenic Risk | Iron replacement therapy with ferric carboxymaltose (ACCRUFER) is considered low risk during pregnancy. Animal studies have not shown teratogenic effects. In humans, iron deficiency anemia is associated with adverse maternal and fetal outcomes, and correction may improve outcomes. No specific fetal risks are identified; however, administration during the first trimester should be limited to cases of significant iron deficiency due to absence of large-scale human studies. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to ferric maltol or any component","Iron overload syndromes (e.g., hereditary hemochromatosis)","Anemias not due to iron deficiency (e.g., thalassemia, lead poisoning)"]
| Precautions | ["Risk of iron overload in patients with chronic hemolytic anemias or disorders of iron metabolism","Iron accumulation with repeated dosing may occur; monitor serum ferritin and hemoglobin","Contraindicated in patients with iron overload syndromes (e.g., hemochromatosis)"] |
| Food/Dietary | Avoid high-calcium foods (dairy, fortified juices) within 1 hour of dosing. Calcium can chelate iron and reduce absorption. Avoid concomitant ingestion of coffee, tea, or red wine as tannins inhibit iron absorption. Foods high in vitamin C (citrus, tomatoes) may enhance absorption but are not required to be avoided. |
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| Fetal Monitoring | Monitor hemoglobin, hematocrit, serum ferritin, and transferrin saturation before and during therapy to assess response. Blood pressure and heart rate should be monitored during infusion due to risk of hypotension. Watch for hypersensitivity reactions (anaphylaxis, urticaria). In pregnancy, fetal heart rate monitoring is not routinely required but may be considered if maternal hypotension occurs. |
| Fertility Effects | No known adverse effects on fertility. Correction of iron deficiency anemia may improve ovarian function and fertility outcomes. There are no data suggesting impairment of male or female reproductive function. |
| Clinical Pearls | ACCRUFER (ferric maltol) is indicated for iron deficiency anemia in adults with inflammatory bowel disease (IBD). Monitor hemoglobin, ferritin, and iron saturation. Absorption is increased in acidic environment; avoid concomitant use with proton pump inhibitors or antacids. May cause dark stools, which is benign but should be differentiated from GI bleeding. Dose adjustment not required in renal impairment. Not recommended for patients with iron overload conditions. |
| Patient Advice | Take ACCRUFER on an empty stomach, at least 1 hour before or 2 hours after meals. · Avoid taking with antacids or medications that reduce stomach acid, as they may decrease absorption. · Do not crush, chew, or split the capsule; swallow whole. · Expect dark or black stools; this is normal and not harmful. · Contact your healthcare provider if you experience severe abdominal pain, vomiting, or signs of allergic reaction. · Complete the full course as prescribed, even if symptoms improve. |