VIDEO TRANSCRIPT

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VIBERZI logo

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Who Is Right for VIBERZI?

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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:
I’m Victor, AI Facilitator, here to help you identify the patients with IBS-D who could be candidates for treatment with VIBERZI.¹

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.

Victor:
To start, let’s focus on adult patients with moderate-to-severe IBS-D who have pain-dominant symptoms.

The typical VIBERZI patient is someone who has been actively seeking relief. Take a look at their current and past treatments. Many patients have tried an average of 3.6 over-the-counter medicines before seeing a physician. They may be trying dietary and lifestyle changes, self-treating with over-the-counter medications, or adding probiotic supplements to their diet to help digestion.²

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Data from a web-based survey commissioned by the American Gastroenterological Association on IBS in America in December 2015. The survey included a total of 1587 respondents (both diagnosed and undiagnosed) suffering from IBS-D.²

Victor:

And patients often share how their abdominal pain and diarrhea disrupt their everyday life. Claire, one of the hypothetical patients featured here, points to the difficulty of having symptoms come on without warning. In a different survey that included 1587 patients with IBS-D, the majority of patients reported that their symptoms come and go, but most of these patients are symptom free for only a few days or less before they return.²

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Data from a web-based survey commissioned by the American Gastroenterological Association on IBS in America in December 2015. The survey included a total of 1587 respondents (both diagnosed and undiagnosed) suffering from IBS-D.² This survey was conducted with the financial support of Ironwood Pharmaceuticals, Inc. and Allergan plc.

Victor:
IBS-D can affect patients like Claire, with unpredictable symptoms such as abdominal pain and diarrhea.³

Does this sound like a patient in your practice? You can explore the efficacy data and safety profile to see if VIBERZI could be the right choice for them.

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.

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.

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

REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2024. 2. Shin A, Lembo A. IBS In America: Survey Summary Findings. American Gastroenterological Association; 2015:1-45. 3. Ballou S, McMahon C, Lee HN, et al. Effects of irritable bowel syndrome on daily activities vary among subtypes based on results from the IBS in America survey. Clin Gastroenterol Hepatol. 2019;17(12): 2471-2478.e3. doi:10.1016/j.cgh.2019.08.016