Description

Ferric Citrate is contraindicated in patients with iron overload syndromes.

Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.

There are no available data on Ferric Citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. There are no human data regarding the effect of Ferric Citrate in human milk, the effects on the breastfed child, or the effects on milk production.

Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with Ferric Citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control. Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Ferric Citrate and monitor iron parameters while on therapy. Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.

Pediatric Use: The safety and efficacy of Ferric Citrate have not been established in pediatric patients. Geriatric Use: Clinical studies of Ferric Citrate included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of Ferric Citrate.

No data are available regarding overdose of Ferric Citrate in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of Ferric Citrate) per day. Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores, especially when concomitant intravenous iron is used.