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Viberzi Generic Name & Formulations
Legal Class
CIV
General Description
Eluxadoline 75mg, 100mg; tabs.
Pharmacological Class
Mu-opioid receptor agonist.
How Supplied
Tabs—60
Manufacturer
Generic Availability
NO
Viberzi Indications
Indications
Treatment of irritable bowel syndrome with diarrhea (IBS-D).
Viberzi Dosage and Administration
Adult
Take with food. 100mg twice daily. Patients with mild or moderate hepatic impairment, moderate or severe renal impairment, ESRD (not on dialysis), receiving concomitant OATP1B1 inhibitors (see Interactions), or unable to tolerate 100mg dose: 75mg twice daily.
Children
Not established.
Viberzi Contraindications
Contraindications
Without a gallbladder. Biliary duct obstruction. Sphincter of Oddi disease or dysfunction. Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks/day. History of pancreatitis or structural disease of the pancreas (including pancreatic duct obstruction). Severe hepatic impairment. History of chronic or severe constipation or sequelae from constipation. Mechanical GI obstruction.
Viberzi Boxed Warnings
Not Applicable
Viberzi Warnings/Precautions
Warnings/Precautions
Discontinue if severe constipation develops. Increased risk of sphincter of Oddi spasm and pancreatitis; monitor for new or worsening abdominal pain (eg, acute epigastric or biliary), with or without nausea/vomiting, or associated with liver or pancreatic enzyme elevations; discontinue and treat if symptoms occur; do not restart if biliary duct obstruction or sphincter of Oddi spasm develops. Assess alcohol intake prior to initiation. Mild or moderate hepatic impairment, moderate or severe renal impairment, ESRD (not on dialysis): see Adult dose. Pregnancy. Nursing mothers.
Viberzi Pharmacokinetics
Elimination
Fecal (major), renal. Half-life: 3.7–6 hours.
Viberzi Interactions
Interactions
Avoid excessive alcohol. Potentiated by OATP1B1 inhibitors (eg, cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, saquinavir, tipranavir, rifampin, eltrombopag). May be potentiated by strong CYP inhibitors (eg, ciprofloxacin, gemfibrozil, fluconazole, clarithromycin, paroxetine, bupropion); monitor. Increased risk for constipation with alosetron, anticholinergics, opioids; avoid. May potentiate OATP1B1 and BCRP substrates (eg, rosuvastatin: use lowest effective dose of rosuvastatin) or CYP3A substrates with narrow therapeutic index (eg, alfentanil, cyclosporine, ergots, fentanyl, pimozide, quinidine, sirolimus, tacrolimus); monitor.
Viberzi Adverse Reactions
Adverse Reactions
Constipation, nausea, abdominal pain; sphincter of Oddi spasm, pancreatitis, hypersensitivity reactions (discontinue if occur).
Viberzi Clinical Trials
See Literature
Viberzi Note
Not Applicable
Viberzi Patient Counseling
See Literature
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