What is the trade name of eluxadoline, and what are the recommended doses and contraindications for adult patients with irritable bowel syndrome with diarrhea?

Eluxadoline Trade Name and Clinical Use

The trade name for eluxadoline is VIBERZI, and it is FDA-approved for treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. 1

Recommended Dosing

Standard dose: 100 mg twice daily taken with food 2, 1

Reduced dose of 75 mg twice daily is required for:

• Patients unable to tolerate the 100 mg dose 2, 1
• Mild or moderate hepatic impairment 2, 1
• Concomitant use of OATP1B1 inhibitors 2, 1
• Moderate or severe renal impairment, or end-stage renal disease not yet on dialysis 1

Absolute Contraindications

VIBERZI is absolutely contraindicated in the following patients: 1

• Patients without a gallbladder - this is the most critical contraindication, as all 10 sphincter of Oddi spasm events in clinical trials occurred in post-cholecystectomy patients 2, 3
• Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction 1
• Alcoholism, alcohol abuse, alcohol addiction, or those who drink more than 3 alcoholic beverages per day 2, 1
• History of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction 1
• Known hypersensitivity reaction to VIBERZI 1
• Severe hepatic impairment (Child-Pugh Class C) 1
• History of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction 1

Clinical Efficacy

VIBERZI demonstrates moderate efficacy for IBS-D symptoms: 2, 4

• 27.2% of patients achieved FDA composite endpoint (improvement in both abdominal pain and stool consistency) versus 16.7% with placebo 2
• Particularly effective for stool consistency (RR 0.84; 95% CI 0.80-0.88) and urgency reduction (RR 0.84; 95% CI 0.78-0.90) 2
• 30.9% achieved European Medicines Agency endpoint versus 19.5% with placebo 2

Safety Profile and Critical Warnings

Most common adverse events (occurring in >5% of patients): 2, 1

• Constipation (8%) 2
• Nausea (7%) 2
• Abdominal pain (7%) 2

Serious adverse events requiring immediate discontinuation: 2, 1

• Pancreatitis: 5 cases occurred in clinical trials (0.3% incidence), all associated with absence of gallbladder or alcohol abuse 2, 3
• Sphincter of Oddi spasm: 8 cases in clinical trials, all in patients without a gallbladder, with most occurring within 1 week of starting the 100 mg dose 2, 3

Patients must immediately discontinue VIBERZI and seek medical attention if they develop: 1

• New or worsening abdominal pain with or without nausea and vomiting 1
• Acute biliary pain with liver or pancreatic enzyme elevations 1
• Severe constipation 1

Clinical Positioning

The American Gastroenterological Association (AGA) suggests using eluxadoline as a second-line option for IBS-D (conditional recommendation, moderate certainty), particularly when rifaximin is ineffective or when continuous daily therapy is preferred over intermittent courses 2, 5

Rifaximin remains the preferred first-line prescription agent due to its superior safety profile, with eluxadoline reserved for patients requiring continuous therapy or those with predominant diarrhea and urgency 5, 6

Critical Clinical Pitfall

Never prescribe VIBERZI to post-cholecystectomy patients - this is the single most important contraindication to remember, as all sphincter of Oddi spasm events occurred in patients without a gallbladder, and the AGA explicitly advises against its use in this population 2, 6, 3