Eluxadoline
VIBERZI
Pronunciation: el-ux-AD-oe-leen (vye-BER-zee)
What it isMu- and kappa-opioid agonist acting mainly in the gut; irritable bowel syndrome with diarrhea.
Why this oneLow systemic exposure slows bowel transit with relatively little central opioid effect.
What limits it⚑ Pancreatitis and sphincter-of-Oddi spasm can be fatal; avoid without a gallbladder or with heavy alcohol use.
Pearls
- Schedule IV; euphoria reported
- Take with food; constipation and nausea most common
- 75 mg bid for hepatic or renal impairment, or OATP1B1 inhibitors
- Contraindicated in Child-Pugh C or chronic severe constipation
FDA-approved for
- IBS with diarrhea (2015)
Principal riskPancreatitis; contraindicated without a gallbladder
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityPancreatitis and sphincter-of-Oddi spasm are defining risks; misuse and opioid toxicity can occur.
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Irritable bowel syndrome with diarrhea (IBS-D) | Adults | 100 mg BID | 100 mg BID | 100 mg BID |
| IBS-D (reduced-dose population) | Intolerant of 100 mg; on OATP1B1 inhibitor; mild-moderate hepatic impairment; moderate-severe renal impairment or ESRD not on dialysis | 75 mg BID | 75 mg BID | 75 mg BID |
Renal Moderate-severe renal impairment or ESRD not yet on dialysis: 75 mg BID
Hepatic Mild-moderate (Child-Pugh A/B): 75 mg BID; severe (Child-Pugh C): contraindicated
Instructions
- Take twice daily with food.
- Discontinue if severe constipation develops.
- If a dose is missed, take the next dose at the regular time; do not double.
Available strengths
- tab 75, 100 mg
Contraindications
- Absence of a gallbladder
- Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
- Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks per day
- History of pancreatitis or structural pancreatic disease (incl. known/suspected pancreatic duct obstruction)
- Severe hepatic impairment (Child-Pugh C)
- History of chronic or severe constipation or its sequelae, or known/suspected mechanical GI obstruction
Cautions
- Pancreatitis and sphincter of Oddi spasm — discontinue if symptoms develop
- Hypersensitivity reactions including anaphylaxis
- Constipation — stop if severe; avoid other constipating drugs
Adverse reactions
- Constipation
- Nausea
- Abdominal pain
Pregnancy No human data; no teratogenicity in animal studies.
Lactation No human data; eluxadoline present in rat milk.
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 75 mg | tab | 60 BID | — | $1,686.23 | not offered |
| 100 mg | tab | 60 BID | — | $1,685.61 | not offered |
Generic entry2033 est.
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Self-check
- Which two settings should avoid eluxadoline?
No gallbladder or heavy alcohol use. - Which two potentially fatal pancreatic/biliary complications occur?
Pancreatitis and sphincter-of-Oddi spasm.