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There have been a number of studies that may help to inform how you can initiate XPHOZAH in your patients.
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XPHOZAH 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 to any dose of phosphate binder therapy.
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XPHOZAH approval was based on efficacy and safety data from three phase three studies, 2 monotherapy and one as add on to phosphate binders.
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The phase three add on trial was called AMPLIFY.
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The AMPLIFY trial evaluated XPHOZAH as add on therapy in patients on phosphate binders for whom phosphate binders were not working well, defined in the trial as serum phosphate of greater than or equal to 5.5 mg/dL.
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Per the design of that four week trial, the protocol did not allow for change in the phosphate binder dose.
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The trial met its primary and additional efficacy endpoints.
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Additionally, the open label OPTIMIZE trial evaluated different ways to initiate XPHOZAH treatment in patients not achieving an adequate response while on a phosphate binder.
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At XPHOZAH initiation, one arm added XPHOZAH 30 mg BID and stopped their phosphate binder therapy, and one arm added XPHOZAH 30 mg BID and reduced their phosphate binder dose by at least 50%.
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In OPTIMIZE, after two weeks, a patient's phosphate binder therapy could be added back in the arm where it was stopped and titrated in both arms based on serum phosphorus with the aim of optimizing phosphorus management and getting patients to goal.
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The most common adverse reaction is diarrhea, which occurred in 43 to 53% of patients.
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The majority of diarrhea was reported to be mild to moderate.
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The severe diarrhea was reported in 5% of patients.
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If diarrhea occurred, it tended to be reported soon after initiation and resolve over time or with dose reduction, but could occur at any time during treatment.
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XPHOZAH (tenapanor) indication and important safety information indication. XPHOZAH (tenapanor) 30 mg BID is indicated to reduce serum phosphorus in adults with chronic kidney disease,
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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.
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Important Safety Information. Contraindications. XPHOZAH is contraindicated in pediatric patients under six years of age.
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Patients with known or suspected mechanical gastrointestinal obstruction.
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Warnings and Precautions. Diarrhea. Patients may experience severe diarrhea.
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Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
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Most Common Adverse Reactions. Diarrhea, which occurred in 43 to 53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH treated patients with CKD on dialysis across trials.
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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.
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Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH.
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Severe diarrhea was reported in 5% of XPHOZAH treated patients in these trials.
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For additional safety information, please see full Prescribing Information available at XPHOZAH-hcp.com.
Salvatore Chillemi
MOA
Andrew Lazar