Recommended Dosing for Eluxadoline (Viberzi) in IBS-D
The standard recommended dose of eluxadoline for IBS-D is 100 mg twice daily, with a reduced dose of 75 mg twice daily for specific patient populations including those with hepatic impairment, concomitant OATP1B1 inhibitor use, or those who cannot tolerate the higher dose. 1
Standard Dosing Protocol
- Standard dose: 100 mg twice daily for most patients with IBS-D
- Reduced dose (75 mg twice daily) is recommended for:
- Patients who cannot tolerate the 100 mg dose
- Patients with mild to moderate hepatic impairment
- Patients receiving concomitant OATP1B1 inhibitors
- Patients aged ≥65 years (who may have better response to the lower dose) 2
Contraindications
Eluxadoline is absolutely contraindicated in patients with:
- No gallbladder (history of cholecystectomy)
- Alcohol consumption exceeding 3 drinks per day
- History of pancreatitis or pancreatic duct obstruction
- History of sphincter of Oddi disease or dysfunction
- Biliary duct obstruction
- Severe hepatic impairment
- Severe or chronic constipation
- Known mechanical gastrointestinal obstruction 1, 3
Efficacy Profile
Eluxadoline has demonstrated efficacy in:
- Improving stool consistency (RR 0.84; 95% CI 0.80-0.88)
- Reducing urgency (50% urgency-free days: RR 0.84; 95% CI 0.78-0.90)
- Improving global IBS-D symptoms (FDA endpoint responders: 27.2% vs 16.7% for placebo)
- Improving quality of life measures 1
The drug shows better efficacy for diarrhea symptoms than for abdominal pain, making it particularly suitable for patients with predominant and bothersome diarrhea rather than those with predominant severe abdominal pain 1.
Safety Considerations
The most common adverse events include:
Serious adverse events to monitor for:
- Pancreatitis (0.4% incidence)
- Sphincter of Oddi spasm (0.5% incidence)
These serious events occur primarily in patients without a gallbladder, within the first week of treatment, and resolve with discontinuation of the medication 4.
Clinical Pearls
- Discontinuation rates due to adverse events are approximately 8% with eluxadoline vs 4% with placebo 1
- Patients aged ≥65 years may have better response rates with the lower 75 mg dose 2
- Eluxadoline may be particularly effective in patients who have had inadequate symptom control with loperamide 5
- The 75 mg dose has similar efficacy to the 100 mg dose but with potentially fewer adverse events 1
Monitoring Recommendations
- Assess for improvement in diarrhea symptoms and stool consistency within the first 4 weeks
- Monitor for constipation, especially during the first weeks of treatment
- Be vigilant for signs of pancreatitis or sphincter of Oddi spasm (severe abdominal pain with elevated liver enzymes or lipase)
- Consider dose reduction to 75 mg twice daily if patient experiences intolerable side effects at the higher dose
By following these dosing recommendations and carefully selecting appropriate patients for therapy, eluxadoline can be an effective treatment option for IBS-D patients, particularly those with predominant diarrhea symptoms.