IBSRELA Video Library
Select from the following topics
Video Vignettes
Short vignettes covering various topics related to IBSRELA and IBS-C
A patient and provider* describe the importance of shared decision-making with IBSRELA†
*Susan is a compensated advisor to Ardelyx.
†Individual results and experiences may vary.
Dr. Brian Lacy reviews key clinical data for IBSRELA from T3MPO-2
Dr. Darren Brenner discusses IBSRELA patient-reported outcomes from T3MPO-2
Dr. Jignesh Shah’s clinical experience with IBSRELA
National Broadcasts
Hear from experts about IBS-C, the MOA of IBSRELA, and clinical data
Dr. Satish Rao presents: IBSRELA, a different mechanism of action for adults with IBS-C
Dr. Brooks Cash presents: IBSRELA, a different mechanism of action for adults with IBS-C
Case Studies
Dr. Satish Rao presents an IBSRELA patient case
Leading gastroenterologists answer questions about IBSRELA
When can patients on IBSRELA expect to see results?
Answered by Dr. Darren Brenner
Are the results seen with IBSRELA durable?
Answered by Dr. Brian Lacy
Is IBSRELA a secretagogue?
Answered by Dr. Darren Brenner
Does IBSRELA exert an effect on NHE3 outside the GI tract?
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.
