Eluxadoline (Viberzi®)

SELF ADMINISTRATION

Indications for Prior Authorization:
  • Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in adults
Prior Authorization Criteria:
  • Age 18 years or older, AND
  • Diagnosis of moderate to severe IBS-D as confirmed by chart note documentation, AND
  • Has tried and failed dietary modification as confirmed by chart note documentation, AND
  • Has tried and failed or had clinically significant adverse effects from at least two of the following:
    • Bulk forming agent (e.g. psyllium)
    • Anti-diarrhea agent (e.g. loperamide, bismuth subsalicylate)
    • Antispasmodic agent (e.g. dicyclomine, hyoscyamine, diphenoxylate/atropine, hyoscyamine/atropine/scopolamine/phonobarbital), AND
  • Does not have a contraindication to treatment:
    • Patients without a gallbaldder
    • Known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction
    • Alcholism, alcohol abuse, alcohol addiction, or patients who drink more than 3 alcoholic beverages daily
    • History of pancreatitis, structural disease of the pancrease, including known or suspected pancreatic duct obstruction
    • Known hypersensitivity reaction to Viberzi
    • Severe hepatic impairment (Child-Pugh Class C)
    • History of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction
Dosing:
  • Recommended dose: 100 mg twice daily
  • Mild or moderate hepatic impairment: 75 mg twice daily
  • Patients receiving concomitant OATP1B1 inhibitors: 75 mg twice daily
Approval:
  • Initial: 6 months
  • Renewal: 1 year

Last review date: April 24, 2019