Accrufer
(ferric maltol)Dosage & Administration
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Accrufer Prescribing Information
ACCRUFER is indicated for the treatment of iron deficiency in adults.
Recommended Dosage
The recommended dosage of ACCRUFER is 30 mg twice daily, taken 1 hour before or 2 hours after a meal. Do not open, break, or chew ACCRUFER capsules.
Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.
Capsules: ACCRUFER contains 30 mg iron, as ferric maltol, in red capsules printed with “30”.
Pregnancy
Risk Summary
ACCRUFER is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3)] .
In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.
In animal reproduction studies, oral administration of maltol to pregnant Crl: COBS-CD (SD) BR rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.
Data
Animal Data
In embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. Administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes.
In a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. Administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes.
Lactation
Risk Summary
There are no data on the presence of ACCRUFER in human milk, the effects on the breastfed child, or the effects on milk production. ACCRUFER is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to ACCRUFER.
Pediatric Use
Safety and effectiveness of ACCRUFER have not been established in pediatric patients.
Geriatric Use
Of the 295 patients in the randomized trials of ACCRUFER, 39% of patients were aged 65 and older, while 23% were aged 75 and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
ACCRUFER is contraindicated in patients with a history of:
- Hypersensitivity to the active substance or to any of the excipients [see Description ( 11)] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse.
- Hemochromatosis and other iron overload syndromes [see Warnings and Precautions ( 5.1)] . Use may result in iron overdose [see Overdosage ( 10)].
- Receiving repeated blood transfusions. Use may result in iron overload [see Warnings and Precautions ( 5.2) and Overdosage ( 10)].
Increased Risk of Inflammatory Bowel Disease (IBD) Flare
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.
Iron Overload
Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron [see Contraindications( 4)] . Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy [see Overdosage ( 10) and Clinical Pharmacology ( 12.2)] .
Risk of Overdosage in Children Due to Accidental Ingestion
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.