U.S. Full Prescribing Information (PDF)

 

IMPORTANT SAFETY INFORMATION

Contraindication

AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g. hemochromatosis.

Warnings and Precautions

Iron Overload: Iron absorption from AURYXIA may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT levels) were observed in clinical trials. Assess iron parameters, e.g. serum ferritin and TSAT, prior to initiating AURYXIA and while on therapy. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.

Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Counsel your patients to keep this product out of the reach of children and to call a doctor or poison control center immediately in the case of accidental overdose.

Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established in these populations.

Adverse Events

The most common adverse events with AURYXIA were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing AURYXIA (14%).

Special Populations

Pregnancy Category B and Nursing Mothers: It is not known whether AURYXIA can cause fetal harm. However, overdosing of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.

Pediatric and Geriatric Use: The safety and efficacy of AURYXIA have not been established in pediatric patients. 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 AURYXIA.

Overdose

AURYXIA contains iron. Iron absorption from AURYXIA may lead to excessive elevations in iron stores, especially when concomitant IV iron is used. AURYXIA must be kept out of the reach of children. In case of accidental overdose contact a doctor or poison control center immediately.

Drug Interactions

Doxycycline should be taken at least 1 hour before AURYXIA. Ciprofloxacin should be taken at least 2 hours before or after AURYXIA. Consider separation of the timing of the administration of AURYXIA with drugs where a reduction in their bioavailability would have a clinically significant effect on safety or efficacy. Monitor blood levels of concomitant medications that have a narrow therapeutic range.

Patient Counseling

Dosing and Administration: Inform patients to take AURYXIA as directed with meals and adhere to their prescribed diets. Instruct patients on concomitant medications that should be dosed apart from AURYXIA.

Adverse Reactions: Advise patients that AURYXIA may cause discolored (dark) stools, which is considered normal with oral medications containing iron. Advise patients to report severe or persistent gastrointestinal symptoms to their physician.

You may report side effects to the FDA at 1-800-FDA-1088.
For more information see full
Prescribing Information or call 1-844-44KERYX (844-445-3799).