VIDEO TRANSCRIPT

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VIBERZI logo


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How Does VIBERZI Work?


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AI-generated actor.


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Please see full Prescribing Information by clicking the link on this website, or visit www.rxabbvie.com/pdf/viberzi_pi.pdf


Victor:
VIBERZI® (eluxadoline) tablets, for oral use, CIV, is indicated in adults for the treatment of irritable bowel syndrome with diarrhea.1

IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS


VIBERZI is contraindicated in patients:


  • Without a gallbladder.
  • With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; or structural diseases of the pancreas.
  • With alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day.
  • With a known hypersensitivity reaction to VIBERZI.
  • With severe hepatic impairment.
  • With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.

Please see additional Important Safety Information at the end of this video.


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AI-generated actor.


Victor:
I’m Victor, AI Facilitator, here to help you explore the mechanism of action of VIBERZI and how it’s thought to work—by looking at the GI tract and seeing how those actions might relate to mechanisms behind IBS-D.

Within the GI tract are opioid receptors, including mu, kappa, and delta. These receptors are believed to play a role in the regulation of GI motility, secretion, and visceral sensation.2 You may have seen this illustrated in the infographic at the top of the page.

VIBERZI is a mixed opioid receptor modulator that binds to multiple opioid receptors in the GI tract. It is an agonist of both kappa and mu receptors and an antagonist of delta receptors.1,2 Though the exact mechanism is unknown, VIBERZI is thought to decrease visceral hypersensitivity and control GI motility, which are important factors in the pathophysiology of IBS-D.1,4,5


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AI-generated actor.


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MOA is unknown; based on nonclinical data.1

Victor:

It’s also important to note that VIBERZI is a non-narcotic, schedule IV medication, which is defined as having low potential for abuse and low risk for dependence.1-6

Ready to learn more about VIBERZI for IBS-D? You can find clinical results, dosing information, and more on this site.


INDICATIONS AND USAGE

VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

VIBERZI is contraindicated in patients:


  • Without a gallbladder.
  • With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; or structural diseases of the pancreas.
  • With alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day.
  • With a known hypersensitivity reaction to VIBERZI.
  • With severe hepatic impairment.
  • With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.

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AI-generated actor.


Victor:

WARNINGS AND PRECAUTIONS

Pancreatitis:


  • Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting.

Sphincter of Oddi Spasm:


  • There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking VIBERZI. Serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI.

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AI-generated actor.


Victor:

Hypersensitivity Reactions:


  • In postmarketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration. Some of these reactions occurred after the first one or two doses of VIBERZI.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

Constipation:


  • Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration. In postmarketing experience, severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience severe constipation. Avoid use with other drugs that may cause constipation.

ADVERSE REACTIONS

The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.


Please see full Prescribing Information by clicking the link on this website, or visit www.rxabbvie.com/pdf/viberzi_pi.pdf


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AI-generated actor.


REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2024. 2. Dove LS, Lembo A, Randall CW, et al. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a Phase 2 study. Gastroenterology. 2013;145:329-338. 3. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta, a mixed μ opioid receptor agonist/ μ opioid receptor antagonist. Br J Pharmacol. 2012;167:1111-1125. 4. Delvaux M. Role of visceral sensitivity in the pathophysiology of irritable bowel syndrome. Gut. 2002;51(Suppl 1):i67-i71. 5. Lembo AJ, Lacy BE, Zuckerman MJ, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374:242-253. 6. Drug scheduling. United States Drug Enforcement Administration website. Accessed March 3, 2026. https://www.dea.gov/drug-information/drug-scheduling


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INDICATIONS AND USAGE

VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

VIBERZI is contraindicated in patients:

  • Without a gallbladder.
  • With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; or structural diseases of the pancreas.
  • With alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day.
  • With a known hypersensitivity reaction to VIBERZI.
  • With severe hepatic impairment.
  • With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Pancreatitis:
  • Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting.
Sphincter of Oddi Spasm:
  • There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking VIBERZI. Serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI.
Hypersensitivity Reactions:
  • In postmarketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration. Some of these reactions occurred after the first one or two doses of VIBERZI.
  • Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
Constipation:
  • Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration. In postmarketing experience, severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience severe constipation. Avoid use with other drugs that may cause constipation.
ADVERSE REACTIONS

The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.

Please see full Prescribing Information.