While Medicare Part D coverage has changed, XPHOZAH is available. Learn more
Pinch to zoom.
The data from the OPTIMIZE trial are being provided for informational purposes only. This is not intended to replace your clinical judgment or dosing information in FDA-approved product labeling.
Patient Population
Patients on dialysis with serum phosphorus >5.5 mg/dL on a phosphate binder.1
Trial Limitations
Open-label trial; no placebo control group; endpoints not controlled for type 1 error; results considered descriptive.1
BID = twice daily; R = randomized.
Safety1
XPHOZAH Initiation Arm 1: Added XPHOZAH, stopped binder
XPHOZAH Initiation Arm 2: Added XPHOZAH, reduced binder
Sprague SM, Weiner DE, Tietjen DP, et al. Tenapanor as therapy for hyperphosphatemia in maintenance dialysis: results from the OPTIMIZE study. Kidney 360. 2024;5(5):732-742.
XPHOZAH® (tenapanor) full Prescribing Information. Waltham, MA: Ardelyx, Inc.; 2023.
XPHOZAH (tenapanor) 30 mg BID is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
XPHOZAH is contraindicated in:
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.
For additional safety information, please see full Prescribing Information.
XPHOZAH (tenapanor) 30 mg BID is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
XPHOZAH is contraindicated in:
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.
For additional safety information, please see full Prescribing Information.