Auryxia (ferric citrate) is currently indicated for the control of serum phosphorus levels in patients with CKD on dialysis.
“Data from this poster at ASN provide the first real-world evidence of the effect of Auryxia in treating hyperphosphatemia in people on dialysis,” said
About the Case Study Retrospective Data
Data from a retrospective chart review of 92 patients were collected by seven health care providers at multiple clinics across the U.S. Patients with CKD on dialysis who had been taking Auryxia for the control of serum phosphorus for a minimum of six months were selected to participate. The retrospective data demonstrate Auryxia’s effect in dialysis-dependent chronic kidney disease patients in routine clinical practice.
Of the 92 patient charts, 25 people were receiving peritoneal dialysis and 62 people were receiving in-center hemodialysis as part of routine clinical care. At the time of Auryxia treatment initiation, 21 patients (23%) were naïve to phosphate binders, while the remaining were treated with sevelamer (n = 37, 52%), calcium-based binders (n = 20, 28%), sevelamer + calcium (n = 10, 14%), or another binder (n = 4, 6%). Data collected included patients who took Auryxia for at least six months.
Case Study Data:
Mean serum phosphorus levels: At baseline, patients had a mean serum phosphorus level of 6.55 mg/dL, which was lowered to 5.41 mg/dL after six months of treatment with Auryxia. The reduction in serum phosphorus levels were comparable in patients taking Auryxia who switched from sevelamer and/or calcium and in patients new to binders.
Daily tablets: At baseline, patients were taking a mean of 11.7 tablets per day on their prior phosphate binder(s). Patients who stopped their prior phosphate binder(s) and switched to Auryxia had a mean tablet burden of 7.3 tablets per day at month six of treatment with Auryxia.
Iron biomarker levels (TSAT and Ferritin): At baseline, mean hemoglobin, ferritin, and transferrin saturation were 10.6 g/dL, 734 ng/mL, and 27.1 percent, respectively. These levels increased by month three and were maintained through month six. After six months of treatment with Auryxia, these levels were 11.1 g/dL, 947 ng/mL, and 37 percent, respectively.
Discontinuations: Five patients discontinued treatment after three months of treatment: three received kidney transplants, one discontinued dialysis and one was lost to follow-up.
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, 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: whether we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that the
KERYX BIOPHARMACEUTICALS CONTACTS:
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