Generic Name and Formulations:
Eluxadoline 75mg, 100mg; tabs.
Indications for VIBERZI:
Treatment of irritable bowel syndrome with diarrhea (IBS-D).
Take with food. 100mg twice daily. Patients with mild or moderate hepatic impairment, receiving concomitant OATP1B1 inhibitors (see Interactions), or unable to tolerate 100mg dose: 75mg twice daily.
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.
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. Pregnancy. Nursing mothers.
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.
Mu-opioid receptor agonist.
Constipation, nausea, abdominal pain; sphincter of Oddi spasm, pancreatitis, hypersensitivity reactions (discontinue if occur).