Medication Monitor



Generic Name (Trade Name—Company)
Notes
September 20, 2019

Tenapanor

(Ibsrela—Ardelyx)
FDA approves new drug for treatment of IBS-C

FDA approved tenapanor, a 50-mg, twice-daily oral agent for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.  

The drug is a minimally absorbed small molecule that acts locally in the GI tract to inhibit the sodium–hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain.

The recommended dosage in adults is 50 mg orally twice daily, to be taken immediately before breakfast or the first meal of the day and immediately before dinner.  

The prescribing information includes a boxed warning for the risk of serious dehydration in pediatric patients. It is contraindicated in patients younger than 6 years and should be avoided in children ages 6 years to 12 years, as well as in patients with known or suspected mechanical GI obstruction.

The most common adverse reactions (≥2%) are diarrhea, abdominal distension, flatulence, and dizziness.