IBSRELA: Different Mechanism of Action.* Different Class of Therapy.1
Treatment for irritable bowel syndrome with constipation (IBS-C) is not one size fits all. Because of the significant impact of IBS-C symptoms on patients, it is important to find the right treatment for each individual patient.2-9
IBSRELA is the First and Only NHE3 Inhibitor for IBS-C1,10
IBSRELA is a retainagogue
IBSRELA is not a secretagogue or a GC-C agonist1,10
Effective with a quick onset of action
Improvements in abdominal and bowel symptoms observed as early as week 1 with efficacy sustained over 26 weeks11,12
Established safety and tolerability profile in over 1,200 adult
patients with IBS-C across two phase 3 trials
The most commonly reported adverse events (incidence ≥2% and greater than placebo) were diarrhea (16%), abdominal distension (3%), flatulence (3%), and dizziness (2%)1
Dosed as one 50-mg tablet BID1†
GC-C=guanylate cyclase-C.
*Mechanism of action=sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor.
†Instruct patients to take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior to dinner.
Your Adult Patients With IBS-C May Be Ready for Something Different
Only 25% of adults were very satisfied with their prescription treatment in a 2015 survey of prescription-treated patients with IBS-C13
Based on data from a 2015 online survey of 1,667 patients with IBS-C, 311 of the 1,667 patients were prescription-treated and responded to a 5-point scale where 1 is very dissatisfied and 5 is very satisfied.13
Ask your adult patients with IBS-C,
“Do you want to try something different?”
Review IBSRELA study data
See efficacy
Review IBSRELA safety data
See safety
References:
1. IBSRELA [prescribing information]. Waltham, MA: Ardelyx, Inc.; 2022. 2. Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2012;367(17):1626-1635. 3. Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001;120(3):652-668. 4. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Eating, diet, & nutrition for constipation. Updated May 2018. Accessed August 28, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/constipation/eating-diet-nutrition 5. Zhao Q, Chen YY, Xu DQ, et al. Action mode of gut motility, fluid and electrolyte transport in chronic constipation. Front Pharmacol. 2021;12:630249. 6. Camilleri M, Lasch K, Zhou W. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303(7):G775-G785. 7. Barbara G, Barbaro MR, Fuschi D, et al. Inflammatory and microbiota-related regulation of the intestinal epithelial barrier. Front Nutr. 2021;8:718356. 8. Farzaei MH, Bahramsoltani R, Abdollahi M, Rahimi R. The role of visceral hypersensitivity in irritable bowel syndrome: pharmacological targets and novel treatments. J Neurogastroenterol Motil. 2016;22(4):558-574. 9. Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment and evidence-based medicine. World J Gastroenterol. 2014;20(22):6759-6773. 10. Brenner DM. Mechanism of action considerations in the management of IBS-C. Gastroenterol Hepatol (N Y). 2023;19(12):749-756. 11. Data on file. Ardelyx, Inc. 2018. 12. 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. 13. Rangan V, Ballou S, Shin A, Camilleri M; Beth Israel Deaconess Medical Center GI Motility Working Group, Lembo A. Use of treatments for irritable bowel syndrome and patient satisfaction based on the IBS in America survey. Gastroenterology. 2020;158(3):786-788.e1.
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%).
