XPHOZAH 20 mg 20 mg/1
Tenapanor · TABLET, FILM COATED · Ardelyx, Inc.
XPHOZAH 20 mg is a tablet, film coated containing tenapanor at 20 mg/1, taken oral. Manufactured by Ardelyx, Inc..
Key Facts
- Brand Name
- XPHOZAH 20 mg
- Generic Name
- Tenapanor
- NDC Code (Product)
73154-120- Manufacturer
- Ardelyx, Inc.
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA213931
- Marketing Start
- 10/17/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 of any dose of phosphate binder therapy. XPHOZAH is a sodium hydrogen exchanger 3 (NHE3) inhibitor 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 ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 30 mg orally twice daily before the morning and evening meals ( 2.1 ). Manage serum phosphorus levels and tolerability with dosage adjustments ( 2.1 ). Take just prior to the first and last meals of the day ( 2.2 ). Instruct patients not to take right before a hemodialysis session, and instead take right before the next meal following dialysis ( 2.2 ). 2.1 Recommended Dosage 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. 2.2 Administration Instructions Instruct patients to take XPHOZAH just prior to the first and last meals of the day [see Clinical Pharmacology (12.2) ] . Instruct patients not to take XPHOZAH right before a hemodialysis session, and instead take right before the next meal following dialysis, as patients may experience diarrhea after taking XPHOZAH [see Warnings and Precautions (5.1) ] . Instruct patients who miss a dose to skip the missed dose and take the next dose at the regular time.
Contraindications
4 CONTRAINDICATIONS XPHOZAH is contraindicated in patients under 6 years of age because of the risk of diarrhea and serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.5) ]. XPHOZAH is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Pediatric patients under 6 years of age ( 4 ). Patients with known or suspected mechanical gastrointestinal obstruction ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). Monitor for signs related to loss of efficacy and adjust the dosage of the concomitantly administered drug as needed ( 7.1 ). Sodium Polystyrene Sulfonate (SPS): Separate administration by at least three hours ( 7.2 ). 7.1 OATP2B1 Substrates Tenapanor is an inhibitor of intestinal uptake transporter, OATP2B1 [see Clinical Pharmacology (12.3) ] . Drugs which are substrates of OATP2B1 may have reduced exposures when concomitantly taken with XPHOZAH. Monitor for signs related to loss of efficacy and adjust the dose of concomitantly administered drug as needed. Enalapril is a substrate of OATP2B1. When enalapril was coadministered with XPHOZAH (30 mg twice daily for five days), the peak exposure (C max ) of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic exposures (AUC) decreased by 50 to 65% compared to when enalapril was administered alone [see Clinical Pharmacology (12.3) ] . However, the decrease in enalaprilat's exposure with XPHOZAH may be offset by the inherently higher exposures observed in patients with CKD on dia…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reaction in the combined clinical trials was diarrhea, reported by 43-53% of patients ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ardelyx at 1-844-974-6924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect data from 754 adults with CKD on dialysis taking XPHOZAH in clinical trials as monotherapy and in combination with phosphate binders. Among the 754 patients, 258 patients were exposed to tenapanor for at least 26 weeks and 75 were exposed to tenapanor for at least one year. [see Clinical Studies (14) ] . Most Common Adverse Reaction 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 the XPHOZAH-treated patients were reported to be mild-to-moderate in sev…
Frequently Asked Questions
What is XPHOZAH 20 mg used for?
XPHOZAH 20 mg contains Tenapanor. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is XPHOZAH 20 mg a controlled substance?
XPHOZAH 20 mg is not classified as a controlled substance by the DEA.
What is the generic name for XPHOZAH 20 mg?
The generic name for XPHOZAH 20 mg is Tenapanor. There are 3 other brand versions of Tenapanor.
What is the NDC code for XPHOZAH 20 mg 20 mg/1?
The NDC (National Drug Code) for XPHOZAH 20 mg 20 mg/1 is 73154-120, listed by Ardelyx, Inc..