Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing and Dose Adjustment

Ferric Citrate tablet containing 210 mg of ferric iron equivalent to 1 g ferric citrate for oral use Initial U.S. Approval: 2014 --------------------INDICATIONS AND USAGE---------------------­ Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis (1) -----------------DOSAGE AND ADMINISTRATION---------------­ • Starting dose is 2 tablets orally 3 times per day with meals (2) • Adjust dose by 1 to 2 tablets as needed to maintain serum phosphorus at target levels, up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals. (2) ----------------DOSAGE FORMS AND STRENGTHS-------------­ • Tablets: 210 mg ferric iron, equivalent to 1 g ferric citrate (3) ----------------------CONTRAINDICATIONS------------------------­ • Iron overload syndromes (e.g., hemochromatosis) (4) -----------------WARNINGS AND PRECAUTIONS----------------­ • Iron overload: Monitor ferritin and TSAT. Patients may require a reduction in dose or discontinuation of IV iron. (5.1) • Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. (5.2) • Patients with gastrointestinal bleeding or inflammation: Safety has not been established. (5.3) ------------------------ADVERSE REACTIONS-----------------------­ • In clinical trials, likely adverse reactions occurring with Ferric Citrate included diarrhea, discolored feces, constipation, nausea, and vomiting (6.1)