IBSRELA Video Library

HEAR DIRECTLY FROM
THOUGHT-LEADING EXPERTS

Video Vignettes


Short, expert-led vignettes covering various topics related to IBSRELA and IBS-C

National Broadcasts


Hear from experts about IBS-C, the MOA of IBSRELA, and clinical data

Dr. Satish Rao presents: IBSRELA, an innovative treatment for IBS-C

Dr. Satish Rao presents: IBSRELA, an innovative treatment for IBS-C in adults

Dr. Brooks Cash presents: IBSRELA, an innovative treatment for IBS-C in adults

Dr. Brooks Cash presents: IBSRELA, an innovative treatment for IBS-C in adults

Conference Product Theaters


Listen to experts discuss IBSRELA at key conferences

Dr. Brooks Cash and Dr. Mark Pimentel, DDW 2022

Dr. Brooks Cash and Dr. Mark Pimentel, DDW 2022

Case Studies


Dr. Satish Rao presents an IBSRELA patient case

Dr. Satish Rao presents an IBSRELA patient case

Leading GIs answer questions about IBSRELA


IMPORTANT SAFETY INFORMATION

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. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age.

CONTRAINDICATIONS

  • IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Risk of Serious Dehydration in Pediatric Patients

  • IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
  • Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.

Diarrhea

Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).

INDICATION

IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Please see full Prescribing Information, including Boxed Warning, for additional risk information.