VIBERZI (eluxadoline)

VIBERZI (eluxadoline)

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