Tenapanor is contraindicated in:
Patients less than 6 years of age due to the risk of serious dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction.
- TRADE NAME: Ibsrela (Ardelyx)
- INDICATIONS: Treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
- CLASS: Sodium-hydrogen exchanger 3 (NHE3) inhibitor
- HALF-LIFE: N/A (due to low absorption)
- FDA APPROVAL DATE: 09/12/2019
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
None known - PREGNANCY: Maternal use is not expected to result in fetal exposure to tenapanor.
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
TENAPANOR IS CONTRAINDICATED IN PATIENTS LESS THAN 6 YEARS OF AGE; IN YOUNG JUVENILE RATS, TENAPANOR CAUSED DEATH PRESUMED TO BE DUE TO DEHYDRATION.
AVOID USE OF TENAPANOR IN PATIENTS 6 YEARS TO LESS THAN 12 YEARS OF AGE.
THE SAFETY AND EFFECTIVENESS OF TENAPANOR HAVE NOT BEEN ESTABLISHED IN PEDIATRIC PATIENTS LESS THAN 18 YEARS OF AGE.
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Page last updated 12/21/2024
