Dosing & Uses
Dosage Forms & Strengths
tablet
- 210mg ferric iron (equivalent to 1g ferric citrate)
Hyperphosphatemia
Indicated for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis
Initial: 420 mg (2 tablets) PO TID with meals
Monitor serum phosphorus levels and adjust dose at ≥1-week intervals in decrements or increments of 1 to 2 tablets/day PRN to maintain serum phosphorus at target levels
Not to exceed 12 tablets/day
Iron Deficiency Anemia
Indicated for treatment of iron deficiency anemia in adults with CKD not on dialysis (CKD-NDD)
Initial: 210 mg (1 tablet) PO TID with meals
Titrate as needed to achieve and maintain hemoglobin at target levels
Not to exceed 12 tablets/day
In clinical trial, average dose was 5 tablets/day
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Discolored feces (22%)
Diarrhea (21%)
Constipation (8-18%)
Nausea (10-11%)
1-10%
Vomiting (7%)
Cough (6%)
Hyperkalemia (5%)
Abdominal pain (5%)
Warnings
Contraindications
Iron overload syndromes (eg, hemochromatosis)
Cautions
Iron absorption from ferric citrate may lead to excessive elevations in iron stores; assess iron parameters (eg, serum ferritin, TSAT) before initiating drug and monitor parameters while on therapy; patients receiving IV iron may require a reduced dose or discontinuation
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 yr; keep out of the reach of children
Pregnancy & Lactation
Pregnancy
There are no available data regarding use in pregnant women
An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes, and fetal malformation
Lactation
There are no human data regarding the effect in human milk, the effects on the breastfed child, or the effects on milk production
Data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (DMT-1) and ferroportin-1 (FPN-1); therefore, there is a possibility of infant exposure
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
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.
Pharmacology
Mechanism of Action
Hyperphosphatemia in CKD on dialysis
- Phosphate binder; ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate, which is insoluble and is excreted in the feces
- By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum
Iron deficiency anemia in CKD not on dialysis
- Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract
- After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin
Absorption
Shown to increase serum iron parameters, including ferritin, iron, and TSAT
In a 52-week clinical trial, mean ferritin levels rose from 593 ng/mL to 895 ng/mL, mean TSAT levels rose from 31% to 39%, and mean iron levels rose from 73 mcg/dL to 88 mcg/dL
Administration
Oral Administration
Take with meals
Do not chew or crush tablets because tablets may cause discoloration of mouth and teeth
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Protect from moisture
Images
Patient Handout
Formulary
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