provides a novel mechanism with a triple ACTION to TREAT IBS-C1
How IBSRELA Works1,2
IBSRELA is the first and only NHE3 inhibitor for IBS-C1
NHE3, the sodium/hydrogen exchanger isoform 3, is expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium
IBSRELA acts locally in the gut and is minimally absorbed
By inhibiting NHE3, IBSRELA:
Blocks dietary sodium absorption1,*
By reducing dietary sodium absorption, IBSRELA retains luminal water content, which accelerates intestinal transit time and results in a softer stool consistency.
Decreases intestinal permeability1,†
By decreasing intestinal permeability, IBSRELA reduces abdominal pain.
Decreases visceral hypersensitivity1,†
By decreasing visceral hypersensitivity, IBSRELA reduces abdominal pain.
*In clinical studies of healthy volunteers, IBSRELA has been shown to block the absorption of up to 3 g of dietary salt, with no impact on serum sodium levels.3
†Based on animal models and the relevance to humans is not known.
See the Efficacy
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- IBSRELA [prescribing information]. Waltham, MA: Ardelyx, Inc.; 2022.
- Barbara G, Barbaro MR, Fuschi D, et al. Inflammatory and microbiota-related regulation of the intestinal epithelial barrier. Front Nutr. 2021;8:718356.
- Spencer AG, Labonte ED, Rosenbaum DP, et al. Intestinal inhibition of the Na+/H+ exchanger 3 prevents cardiorenal damage in rats and inhibits Na+ uptake in humans. Sci Transl Med. 2014;6(227):1-12.
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.