For US Healthcare Professionals Only
For US Healthcare Professionals Only
RTP = randomized treatment period; RWP = randomized withdrawal period; SAE = serious adverse event.
*Normal bowel movement frequency ranges from 3 times a day to 3 times a week.
No routine monitoring beyond serum phosphorus levels is required for most patients on XPHOZAH.
Patients should be instructed not to use stool softeners or laxatives while taking XPHOZAH and to contact their healthcare provider if they experience severe diarrhea.1,2,5
Patients should take XPHOZAH just prior to their first and last meals of the day and should be counseled not to take a dose immediately before a hemodialysis session; instead, XPHOZAH should be taken just before the next meal, as some patients may experience diarrhea after dosing.1
If a dose is missed, patients should take XPHOZAH just before the next meal and should not take two doses at the same time.1 For complete dosing and administration information, visit the Dosing page.
XPHOZAH is contraindicated in pediatric patients under 6 years of age and in patients with known or suspected mechanical gastrointestinal obstruction.1
About half of patients may experience diarrhea, which typically occurs early and generally resolves within 2 weeks with continued use or with dose reduction.1
Diarrhea occurred in approximately 43–53% of patients in clinical trials of XPHOZAH. Most cases were mild-to-moderate in severity, with approximately 5% reported as severe. Diarrhea was the only adverse reaction reported in ≥5% of patients.1
In clinical trials, diarrhea was defined as any increase in bowel movement frequency or softening of stool, regardless of severity. Because normal bowel habits vary widely, individual patient experience should be considered.2,5
Anti-diarrheal agents, such as loperamide, may be used as needed to assist patients in the transition to XPHOZAH. Anti-diarrheal use was not systematically prescribed in clinical trials for patients receiving XPHOZAH.2-4
Diarrhea may occur at any time with XPHOZAH but typically appears early in treatment and generally resolves within 2 weeks of continued treatment or with dose reduction.1
XPHOZAH® (tenapanor) full Prescribing Information. Waltham, MA: Ardelyx, Inc.; 2025.
Block GA, Bleyer AJ, Silva AL, et al. Safety and efficacy of tenapanor for long-term serum phosphate control in maintenance dialysis: a 52-week randomized phase 3 trial (PHREEDOM). Kidney360. 2021;2(10):1600-1610.
Ardelyx AMPLIFY Study Protocol. Study Ten-02-202. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjuctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects with Hyperphosphatemia. Edition No. 2: 22 January 2019.
Ardelyx PHREEDOM Study Protocol. Study Ten-02-301. A 26-Week, Phase 3, Open Label Study with a 12-Week, Placebo-Controlled, Randomized Withdrawal Period Followed by an Open Label Long Term Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis and Peritoneal Dialysis. Edition No. 4: 30 May 2018.
Block GA, Rosenbaum DP, Yan A, Chertow GM. Efficacy and safety of tenapanor in patients with hyperphosphatemia receiving maintenance hemodialysis: a randomized phase 3 trial. J Am Soc Nephrol. 2019;30(4):641-652.
Data on File. Ardelyx, Inc. 2020.
Pergola PE, Rosenbaum DP, Yang Y, Chertow GM. A randomized trial of tenapanor and phosphate binders as a dual-mechanism treatment for hyperphosphatemia in patients on maintenance dialysis (AMPLIFY). J Am Soc Nephrol. 2021;32(6):1465-1473.
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.
