FERRIC CITRATE

Other

Brand names: Ferric Citrate

Oral

Mechanism of Action

12.1 Mechanism of Action Hyperphosphatemia in Chronic Kidney Disease on Dialysis Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum. Iron Deficiency Anemia in Chronic Kidney Disease 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.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Ferric citrate is contraindicated in patients with iron overload syndromes (e.g.
• hemochromatosis) [see Warnings and Precautions (5.1)] . Iron overload syndromes (e.g.
• hemochromatosis). ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Iron overload: Monitor ferritin and TSAT
1 ) Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age
2 Risk of Overdosage in Children Due to Accidental Ingestion Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age [see Overdosage (10)]
Advise patients of the risks to children and to keep ferric citrate tablets out of the reach of children

Known Side Effects

11 documented side effects by frequency

Nausea

>10%

Shortness of Breath

1-10%

Vomiting

1-10%

Diarrhea

1-10%

Dizziness

1-10%

Abdominal Pain

1-10%

Headache

1-10%

Itching

1-10%

Constipation

1-10%

Rash

0.1-1%

Back Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral