General Information

Xphozah (tenapanor) is a sodium hydrogen exchanger 3 (NHE3) inhibitor.

Xphozah is specifically 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.

Dosing/Administration

Xphozah is supplied as tablets for oral administration.

The recommended dosage is 30 mg orally twice daily before the morning and evening meals. Monitor serum phosphorus and adjust the dosage as needed to manage gastrointestinal tolerability.

Xphozah should be administered just prior to the first and last meals of the day.

Xphozah should not be taken right before a hemodialysis session, and instead should be taken right before the next meal following dialysis, as patients may experience diarrhea after taking Xphozah.

If a dose of Xphozah is missed, skip the missed dose and take the next dose at the regular time.

Mechanism of Action

Xphozah (tenapanor) is a locally acting inhibitor that targets the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the epithelium of the small intestine and colon. Inhibition of NHE3 by tenapanor results in reduced sodium absorption and decreased phosphate absorption by reducing phosphate permeability through the paracellular pathway.

Clinical Trial Results

The FDA approval of Xphozah was based on a comprehensive development program, including a diverse population of more than 1,000 patients in three Phase 3 clinical trials (PHREEDOM, BLOCK and AMPLIFY) evaluating the efficacy and safety of Xphozah , as monotherapy and in combination with phosphate binder therapy, all of which met their primary and key secondary endpoints. Data from the three clinical trials demonstrated that Xphozah significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.