Home›Tenapanor Hydrochloride

Tenapanor Hydrochloride

Also known as: Ibsrela

Route: Oral

Check Tenapanor Hydrochloride Interactions →

1 interaction on record⛔ Black Box Warning

Tenapanor Hydrochloride has 1 known drug interaction based on U.S. FDA drug labeling data. Notable interactions include combinations with Enalapril. Patients taking Tenapanor Hydrochloride 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: 1
Moderate: 1

Moderate (1)

Tenapanor Hydrochloride + Enalapril— Tenapanor inhibits OATP2B1 transporter, reducing enalapril peak exposure by ~70% and systemic exposure by 50-65%. Monito…

Tenapanor Hydrochloride + Enalapril🟡Moderate

Tenapanor inhibits OATP2B1 transporter, reducing enalapril peak exposure by ~70% and systemic exposure by 50-65%. Monitor blood pressure and adjust enalapril dosage as needed.

⛔ FDA Black Box Warning

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration [see Contraindications (4) , Use in Specific Populations (8.4) ]. Avoid use of IBSRELA in patients 6 years to less than 12 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ] . WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. ( 4 , 8.4 ) Avoid use of IBSRELA in patients 6 years to less than 12 years of age. ( 5.1 , 8.4 ) The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age. ( 8.4 )

Contraindications

4 CONTRAINDICATIONS IBSRELA is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. Patients with known or suspected mechanical gastrointestinal obstruction . Pediatric patients less than 6 years of age. ( 4 , 5.1 , 8.4 ) Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Tenapanor is minimally 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 IBSRELA 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 0.1 times the maximum recommended human dose and in rabbits at doses up to 8.8 times the maximum recommended human dose (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated population 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. Data 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 0.1 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 8.8 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developmental study in mice, tenapanor at doses up to 200 mg/kg/day (ap

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.