Auryxia® is currently indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. Abstracts of the five presentations are accessible on ASN’s website at https://www.asn-online.org/education/kidneyweek/archives/.
Four abstracts related to IDA will be presented together in a poster session on
Abstract Number: 2200
Title: Effects of ferric citrate in adults with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Phase 3 Clinical Trial
Abstract Number: 3705
Title: Hemoglobin response to ferric citrate in subjects with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Data from a Phase 3 clinical trial
Abstract Number: 3429
Title: Effects of ferric citrate on parameters of mineral and bone metabolism in patients with non-dialysis dependent chronic kidney disease treated for iron deficiency anemia
Abstract Number: 3937
Title: Predictors of hemoglobin response to ferric citrate in patients with non-dialysis dependent chronic kidney disease and iron deficiency anemia
One abstract related to the treatment of hyperphosphatemia with Auryxia in the dialysis setting will be presented in a poster presentation on
Abstract Number: 2598
Title: The effect of ferric citrate (Auryxia) on serum phosphate control in dialysis patients: Real-world data
Auryxia (ferric citrate) was approved by the
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. 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. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
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%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/
Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia as well as the expected impact of the supply interruption of Auryxia and the expected timing of when we will have a sufficient supply of Auryxia to make it available to patients again following the supply interruption, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to quickly and successfully identify and resolve the production-related issue; our ability to quickly and successfully identify and engage secondary suppliers of finished drug product; our ability to receive
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy SullivanVice President, Corporate Development and Public Affairs T: 617.466.3519 firstname.lastname@example.org Lora PikeSenior Director, Investor Relations T: 617.466.3511 email@example.com