ferric citrate (Rx)

>10%

Discolored feces (22%)

Diarrhea (21%)

Constipation (8-18%)

Nausea (10-11%)

1-10%

Vomiting (7%)

Cough (6%)

Hyperkalemia (5%)

Abdominal pain (5%)

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

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.

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

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