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Tenapanor

Also known as: Xphozah 10 Mg, Xphozah 20 Mg, Xphozah 30 Mg

Route: Oral

2 interactions on record

Tenapanor has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Enalapril, Sodium Polystyrene Sulfonate. Patients taking Tenapanor should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Tenapanor + Enalapril— Tenapanor inhibits OATP2B1, reducing enalapril peak exposure by ~70% and systemic exposure by 50-65%. Monitor for loss o…
Tenapanor + Sodium Polystyrene Sulfonate— Separate administration by at least 3 hours. SPS binds to many commonly prescribed oral medicines, potentially reducing …

Tenapanor + Enalapril🟡Moderate

Tenapanor inhibits OATP2B1, reducing enalapril peak exposure by ~70% and systemic exposure by 50-65%. Monitor for loss of efficacy and adjust enalapril dose as needed.

Tenapanor + Sodium Polystyrene Sulfonate🟡Moderate

Separate administration by at least 3 hours. SPS binds to many commonly prescribed oral medicines, potentially reducing their absorption.

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 ).

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Tenapanor is essentially non-absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology (12.3) ]. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on XPHOZAH exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.2 times the maximum recommended human dose and in rabbits at doses up to 15 times the maximum recommended human dose (based on body surface area) [see Nonclinical Toxicology (13.1) ] . The estimated background risk of major birth defects and miscarriage for women with CKD on dialysis with hyperphosphatemia is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Animal Data In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day. Tenapanor doses of 10 and 30 mg/kg/day were not tolerated by the pregnant rats and was associated with mortality and moribundity with body weight loss. The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology. No adverse fetal effects were observed in rats at 1 mg/kg/day (approximately 0.2 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 15 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developme

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.