ThIs site is for U.S. healthcare professionals only
Menu

ADVERSE EVENTS

AURYXIA® (ferric citrate) demonstrated safety over the 52-week pivotal trial1

Fewer patients on AURYXIA (41.9%) experienced serious adverse events (SAEs) vs patients taking sevelamer carbonate and/or calcium acetate (49.7%)1

  • SAEs occurring in ≥2% of patients treated with AURYXIA included renal transplant (4.5%), chest pain (3.8%), pneumonia (2.8%), fluid overload (2.1%), gastrointestinal hemorrhage (2.1%), and hypotension (2.1%)1
  • SAEs occurring in ≥2% of patients treated with Active Control included sepsis (5.4%), chest pain (3.4%), fluid overload (3.4%), hypertension (3.4%), renal transplant (3.4%), acute myocardial infarction (2.7%), dyspnea (2.7%), hypotension (2.7%), pneumonia (2.7%), bacteremia (2.0%), cardiac failure congestive (2.0%), coronary artery disease (2.0%), deep vein thrombosis (2.0%), gastroenteritis (2.0%), pulmonary edema (2.0%), pulmonary embolism (2.0%), rectal hemorrhage (2.0%), respiratory failure (2.0%), vascular access complication (2.0%), and vomiting (2.0%)1

 

There were no reported cases of iron overload associated with AURYXIA during the trial

 

AURYXIA demonstrated tolerability over the 52-week pivotal trial2

AURYXIA_Chart1-01

  • 21% of patients on AURYXIA and 14% of those on active control discontinued treatment over 52 weeks. Gastrointestinal (GI) adverse reactions were the most common reason for discontinuing AURYXIA (14%)
  • In a pooled safety analysis of a pivotal Phase III trial and three short-term trials, adverse events reported in more than 5% of patients treated with AURYXIA included diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%), and cough (6%)
  • Patients with inflammatory bowel disease and GI bleeding were excluded from clinical trials

 

Study Design

The safety and efficacy of AURYXIA was studied in a multicenter, randomized, open-label, Phase III trial of 441 hyperphosphatemia patients with chronic kidney disease on hemodialysis and peritoneal dialysis over 56 weeks.

The primary endpoint of the pivotal trial was change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo in a 4-week efficacy assessment (Placebo-Controlled Period), which followed a 52-week safety assessment (Active Control Period). At the final Active Control Period visit, AURYXIA patients were re-randomized to either continue AURYXIA treatment or receive placebo as part of the Placebo-Controlled Period.


FormulationEach AURYXIA® (ferric citrate) tablet contains 210 mg of ferric iron, equivalent to 1 g of ferric citrate.