VIDEO TRANSCRIPT

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GUT RESPONSES logo

HCPs SHARE HOW THEY TREAT IBS-D

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VIBERZI logo

AVO: VIBERZI, also known as eluxadoline, is indicated in adults for the treatment of irritable bowel syndrome with diarrhea. See safety information at the end of this video.

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“I’m happy with my current IBS-D treatment options” appears.

AVO: “I’m happy with my current IBS-D treatment options”

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DR JONATHAN ROSENBERG AND HIS TITLE/LOCATION APPEARS

JONATHAN A. ROSENBERG, MD

Gastroenterologist

GURNEE, ILLINOIS

DR. ROSENBERG: I'm always looking for appropriate treatment options for my IBS-D patients.

Especially when patients return to the office with ongoing complaints of their irritable bowel syndrome with diarrhea, I'm considering what medications might address their symptoms.

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Dr. Rosenberg and the following disclaimer

American Gastroenterological Association Recommendation:

The AGA suggests using eluxadoline in patients with IBS-D.

(Conditional recommendation, moderate certainty in evidence)

• Implementation remark: Eluxadoline is contraindicated in patients without a gallbladder or those who drink more than 3 alcoholic beverages per day.
• Comparator was no drug treatment.

The AGA Guideline uses GRADE methodology, where the phrase “we recommend” indicates strong recommendations and “we suggest” indicates conditional recommendations.

Conditional = Different choices will be appropriate for individual patients consistent with his or her values and preferences. Use shared decision making. Decision aids may be useful in helping patients make decisions consistent with their individual risks, values, and preferences.

Moderate = We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Please refer to the AGA Guideline for complete information on the management of irritable bowel syndrome with diarrhea: Lembo A, et al. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. 2022;163(1):137-151.

DR. ROSENBERG: In my adult patient population with abdominal pain and diarrhea, VIBERZI has proven to be a good option. In fact, the American Gastroenterological Association suggests using eluxadoline in patients with IBS-D.

For many of my IBS-D patients who have tried OTCs and are looking for other options, I have prescribed VIBERZI. In many cases VIBERZI has helped relieve their abdominal pain and diarrhea.

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Indication, Usage and Important Safety Information appears.

AVO

INDICATIONS AND USAGE

VIBERZI® (eluxadoline), schedule four, 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 post marketing 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 post marketing 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 or visit https://www.rxabbvie.com/pdf/viberzi_pi.pdf.