IBS-C Is a Common Condition With a Multifactorial Pathophysiology That Places a Significant Burden on Patients1-3
The burden of IBS-C runs deep3
Patients report IBS-C as bothersome and are willing to give up cornerstones of their life in exchange for symptom relief
IBS-C Has a Multifactorial Pathophysiology1,2
The pathophysiology of IBS-C is believed to involve multiple abnormalities that result in constipation and abdominal pain:
Decreased colonic contractions and water imbalances leading to hard stool and infrequent defecation4-6
Widened tight junctions that lead to the absorption of toxins and bacteria, resulting in an inflammatory response in proximity to nerve fibers throughout the gut epithelium7,8
Enhanced sensitization of afferent nerve pathways8,9
Additional causes may include changes in gut microbiota and other triggers of gut inflammation and immune activation7,8
Many Patients Do Not Adequately Respond to Treatment2
Potentially because of its multifactorial pathophysiology,
77%of patients taking a prescription IBS-C treatment continue to experience residual abdominal and stool-related symptoms.
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- Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014;20(22):6759-6773.
- Quigley EMM, Horn J, Kissous-Hunt M, Crozier RA, Harris LA. Better understanding and recognition of the disconnects, experiences, and needs of patients with irritable bowel syndrome with constipation (BURDEN IBS-C) study: results of an online questionnaire. Adv Ther. 2018;35(7):967-980.
- Ballou S, McMahon C, Lee H-N, Katon J, Shin A, Rangan V et al. Effects of irritable bowel syndrome on daily activities vary among subtypes based on results from the IBS in America Survey. Clin Gastroenterol Hepatol. 2019;17(12):2471-2478.
- Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2012;367(17):1626-1635.
- Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001;120(3):652-668.
- National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. National Digestive Diseases Information Clearinghouse. Constipation. Bethesda, MD: National Institutes of Health; 2013. NIH publication 13-2754.
- Camilleri M. 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.
- Barbara G, Barbaro MR, Fuschi D, et al. Inflammatory and microbiota-related regulation of the intestinal epithelial barrier. Front Nutr. 2021;8:718356.
- 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.
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.
- 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 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%).
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.