IBSRELA: Established Safety and Tolerability Profile in Over 1,200 Adult Patients With IBS-C Across Two Phase 3 Trials1
Most Common Adverse Reactions* in Patients With IBS-C in T3MPO-2 (26 Weeks)1
| Adverse Reactions† | IBSRELA (n=293) |
Placebo (n=300) |
|---|---|---|
| Diarrhea | 16% | 4% |
| Abdominal distension | 3% | <1% |
| Flatulence | 3% | 1% |
| Dizziness | 2% | <1% |
*Reported in at least 2% of IBSRELA-treated patients and at an incidence greater than placebo.
†The adverse reaction profile was similar during the 12-week, double-blind, placebo-controlled treatment period of T3MPO-1, with diarrhea (15% with IBSRELA vs 2% with placebo) and abdominal distension (2% with IBSRELA vs 0% with placebo) as the most common adverse reactions.
In T3MPO-1 (12 weeks) and T3MPO-2 (26 weeks):
-
Diarrhea was typically2,3
- Mild to moderate
- Transient (≤1 week in duration)
- Severe diarrhea was reported in 2.5% of IBSRELA-treated patients compared with 0.2% of patients treated with placebo1
- Discontinuation due to adverse reactions occurred in 7.6% of IBSRELA-treated patients compared with 0.8% of patients treated with placebo, with diarrhea as the most common reason for discontinuation (6.5% vs 0.7%)1
Peer Perspectives
“The data presented are clinically relevant for our patients given the magnitude of improvement, a quick onset of action, and the sustained effect over time seen for both abdominal symptoms and CSBMs.”
—Dr Brian E Lacy
Compensated advisor to Ardelyx
References:
1. IBSRELA [prescribing information]. Waltham, MA: Ardelyx, Inc.; 2022. 2. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303. 3. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293.
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
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%).
