SAFETY

SAFETY

XPHOZAH: Established safety and tolerability profile across three phase 3 clinical trials in 754 XPHOZAH-treated patients with hyperphosphatemia¹

Most common adverse reactions¹

43-53% incidence of diarrhea: the only adverse reaction reported in ≥5% of patients treated with XPHOZAH in the phase 3 clinical trials¹
- Majority mild-to-moderate
5% of patients experienced severe diarrhea¹
If diarrhea occurred, it was typically reported soon after initiation and resolved over time or with dose reduction
Similar rate of SAEs among XPHOZAH and sevelamer-treated patients in PHREEDOM²
In the BLOCK clinical trial, patients treated with XPHOZAH experienced, on average, 3 additional bowel movements per week and softer stools, all while remaining within the normal range*²
Discontinuation rates due to diarrhea in the clinical trials:
- BLOCK: 8% in the RTP and 0% in the RWP³
- PHREEDOM: 16% in the RTP, 1% in the RWP, and 0% in the safety^2,4
- AMPLIFY: 3.4% in the RTP⁵

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.

RELATED LINKS

Dosing

Efficacy

REFERENCES

1.

XPHOZAH® (tenapanor) full Prescribing Information. Waltham, MA: Ardelyx, Inc.; 2025.

2.

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.

3.

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.

4.

Data on File. Ardelyx, Inc. 2020.

5.

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.

Indication

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.

Important Safety Information

Contraindications

XPHOZAH is contraindicated in:

Pediatric patients under 6 years of age
Patients with known or suspected mechanical gastrointestinal obstruction

Warnings and precautions

Diarrhea

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

Most Common Adverse Reactions

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.

Indication

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.

Important Safety Information

Contraindications

XPHOZAH is contraindicated in:

Pediatric patients under 6 years of age
Patients with known or suspected mechanical gastrointestinal obstruction

Warnings and precautions

Diarrhea

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

Most Common Adverse Reactions

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.

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