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FDA Approves Eluxadoline for IBS

Twice daily mu-opioid receptor agonist

Indications: Eluxadoline (Viberzi) is a mu-opioid receptor agonist for the treatment of irritable bowel syndrome with diarrhea in adults.

Dosing: The recommended dose is 100 mg twice daily taken with food. For patients who do not have a gallbladder, are unable to tolerate the 100 mg dose, are receiving concomitant OATP 1B1 inhibitors, or have mild or moderate hepatic impairment, the recommended dose is 75 mg twice daily.

Pharmakokinetics: Following oral dosing, eluxadoline reaches peak plasma concentration in 1.5 to 2 hours. It has linear pharmacokinetics with no accumulation upon repeated dosing. The mean elimination half-life ranges from 3.7 to 6 hours. It is excreted primarily through feces.

Side Effects/Risks: The most common adverse reactions are constipation, nausea, and abdominal pain. Monitor patients without a gallbladder for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations.

Source: Highlights of Prescribing Information: Viberzi (eluxadoline). FDA Website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf. Revised May 2015. Accessed June 2, 2015.