IBSRELA Video Library
HEAR DIRECTLY FROM
THOUGHT-LEADING EXPERTS
Video Vignettes
Short, expert-led vignettes covering various topics related to IBSRELA and IBS-C
Dr. Jignesh Shah shares his clinical experience with IBSRELA and discusses how he identifies patients that may benefit from a therapy with a different mechanism of action
Dr. Darren Brenner discusses treatment satisfaction with IBSRELA and quality-of-life improvement
Dr. Brian Lacy reviews important clinical data for IBSRELA from T3MPO-2
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 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
Case Studies
Dr. Satish Rao presents an IBSRELA patient case
Leading GIs answer questions about IBSRELA
Answered by Dr. Darren Brenner
Answered by Dr. Brian Lacy
Answered by Dr. Darren Brenner
Answered by Dr. Brian Lacy
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.
