Xphozah is a sodium hydrogen exchanger 3 (NHE3) inhibitor that acts locally on intestinal epithelial cells, reducing the absorption of sodium and phosphorus.

1、 Drug name

1. Common name: Tenapanor

2. Product Name: Xphozah

2、 Indications

1. This product is suitable for reducing serum phosphorus levels in adult patients with chronic kidney disease (CKD) undergoing dialysis.

2. As an adjunct therapy, it is used for patients who have insufficient response to phosphate binders or cannot tolerate any dose of phosphate binder treatment.

3. Specifications

Tablets, 30mg.

4、 Main components

Active ingredient: Tenapanor hydrochloride.

5、 Usage and dosage

1. Recommended dosage: 30mg each time, twice a day, taken orally before breakfast and dinner.

2. Usage:

Pre meal requirement: It should be taken immediately before the first and last meal of each day.

Hemodialysis patients: Guide patients not to take medication immediately before hemodialysis treatment, but to take medication before the next meal after dialysis, as diarrhea may occur after taking medication.

Omission treatment: If one dose is missed, the missed dose should be skipped and the next dose should be taken at the next regular medication time. Do not take two doses at the same time.

6、 Dose adjustment

It is recommended to monitor serum phosphorus levels and adjust the dosage based on gastrointestinal tolerance, such as the severity of diarrhea.

7、 Medication precautions

1. Severe diarrhea: The most common adverse reaction of this product is diarrhea. If severe diarrhea occurs, medication should be stopped.

2. Combination use of laxatives: Inform patients not to use stool softeners or laxatives during the use of this product.

3. Vomiting treatment: The specific treatment methods after vomiting are not mentioned in the material. It is recommended to consult medical professionals.

8、 Medication for special populations

1. Pregnant women: Due to the fact that Tenapano is not widely absorbed throughout the body, maternal medication is not expected to expose the fetus to the drug. The existing data does not identify significant risks of birth defects, miscarriage, or adverse maternal fetal outcomes related to medication.

2. Breastfeeding women: Tenapano and its major metabolite (M1) were not detected in the breast milk of lactating women. Breastfeeded infants are not expected to be exposed to medication.

3. Pediatric medication:

Taboo: Prohibited for children under 6 years old due to the risk of diarrhea and severe dehydration.

Safety not established: The safety and efficacy in pediatric patients aged 6 years and above have not been determined.

Toxicity to juvenile animals: Non clinical studies have shown that administration to juvenile rats can lead to serious adverse events such as death, weight loss, and skeletal changes.

4. Medication for the elderly: In clinical studies, patients aged 65 and above accounted for 28%, but insufficient analysis was conducted to determine whether their reactions were different from those of younger patients.

9、 Adverse reactions

The most common adverse reaction is diarrhea (with an incidence rate of 43% -53% in clinical trials), of which 5% are reported as severe diarrhea.

It usually appears in the early stages of medication, but can also occur at any time during treatment.

10、 Contraindications

1. Children under 6 years old.

2. Patients known or suspected to have mechanical gastrointestinal obstruction.

11、 Drug interactions

1. OATP2B1 substrate drug: Tenapano is an inhibitor of the intestinal uptake transporter OATP2B1, which may reduce exposure to co administered drugs such as enalapril. When combined with enalapril, the peak exposure (Cmax) and total exposure (AUC) of its active metabolite enalapril were reduced by approximately 70% and 50-65%, respectively. Although the exposure level is reduced, it is not recommended to adjust the starting dose of enalapril for CKD patients undergoing dialysis, as this population itself has a higher exposure level due to reduced renal clearance. For other OATP2B1 substrate drugs, efficacy should be monitored and dosage adjusted as needed.

2. Sodium polystyrene sulfonate (SPS): The administration of this product should be separated from SPS by at least 3 hours, as SPS can bind with many oral medications.

12、 Storage method

1. Temperature: Store at room temperature of 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing for brief fluctuations to 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Moisture proof: The bottle cap must be kept tightly closed to prevent moisture. It should be stored in the original bottle and keep the desiccant inside the bottle in a dry place.

Xphozahinformation