SAFETY

XPHOZAH: Established safety and tolerability 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 trials
- Majority mild-to-moderate
- Typically reported soon after initiation and resolved over time or with dose reduction
5% of patients experienced severe diarrhea
Similar rate of SAEs among XPHOZAH- and sevelamer-treated patients in PHREEDOM²

SAE = serious adverse event.

Patient counseling

Patients should be counseled not to take XPHOZAH right before a hemodialysis session, and to take XPHOZAH right before the next meal, as some patients may experience diarrhea.¹

Instruct patients to stop the use of laxatives and stool softeners when starting treatment with XPHOZAH.¹

Instruct patients to contact their healthcare provider if they experience severe diarrhea.¹

Dosing

Efficacy

REFERENCES

XPHOZAH® (tenapanor) full Prescribing Information. Waltham, MA: Ardelyx, Inc.; 2023.

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.

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.