Xphozah (Tenapanor) is an innovative medication approved by the U.S. Food and Drug Administration (FDA), providing a new treatment option for serum phosphorus control in patients with chronic kidney disease (CKD) undergoing dialysis. It exerts its pharmacological effects through a unique sodium-hydrogen exchanger 3 (NHE3) inhibitory mechanism.
What Are the Indications for Xphozah (Tenapanor)?
Primary Therapeutic Indication
Xphozah is specifically indicated to reduce serum phosphorus levels in adult patients with chronic kidney disease (CKD) undergoing dialysis.
As an add-on treatment, it is suitable for patients who have an inadequate response to phosphate binders or cannot tolerate phosphate binder therapy at any dose.
This targeted indication gives it significant clinical value in specific patient populations.
Patient Eligibility Criteria
The medication is particularly intended for patients with poor efficacy or tolerability issues with traditional phosphate binder therapy.
In clinical practice, physicians need to determine the suitability of Xphozah based on the patient’s specific conditions and treatment response.
Specifications and Properties of Xphozah (Tenapanor)
Dosage Specification System
10mg Tenapanor: Yellow, oval, biconvex, film-coated tablets; engraved with "" on one side and "T10" on the other.
20mg Tenapanor: Brown, oval, biconvex, film-coated tablets; engraved with "" on one side and "T20" on the other.
30mg Tenapanor: Red, oval, biconvex, film-coated tablets; engraved with "" on one side and "T30" on the other.
Physicochemical Properties
Tenapanor hydrochloride, the active ingredient, is a white to off-white to light brown hygroscopic amorphous solid.
The compound has extremely low solubility in water, a property closely related to its local mechanism of action.
Excipient Composition
Inactive ingredients in the tablets include colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, and the coating agent OPADRY.
The coating agent consists of hypromellose, titanium dioxide, and triacetin, along with colorants such as yellow iron oxide, red iron oxide, and black iron oxide.
Storage Methods for Xphozah (Tenapanor)
Storage Environment Control
Xphozah should be stored at a standard room temperature of 20°C to 25°C (68°F to 77°F).
Short-term fluctuations between 15°C and 30°C (59°F to 86°F) are permitted, but temperature deviations from the recommended range should be minimized.
Maintenance of Packaging Integrity
The medication is supplied in a specialized packaging system and must always be stored in the original high-density polyethylene bottle.
Each bottle contains a silica gel canister as a desiccant, with a child-resistant polypropylene screw cap featuring an induction-sealed aluminum foil liner to ensure packaging tightness.
Moisture Protection Measures
Keeping the bottle cap tightly closed to prevent moisture intrusion is critical for maintaining drug stability.
During storage and distribution, the medication must be used in the original bottle with the desiccant intact—the desiccant should not be removed from the bottle.
