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 am concerned about the safety of VIBERZI.” appears.

AVO: “I am concerned about the safety of VIBERZI.”

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KIM ORLECK AND HER TITLE/LOCATION APPEARS

KIMBERLY D. ORLECK, PA C

ATLANTA GASTROENTEROLOGY ASSOCIATES

ATLANTA, GEORGIA

KIM: VIBERZI has a proven safety profile. As you may be aware though, there were cases of pancreatitis post marketing, primarily in patients who were status post cholecystectomy. For that reason, this medication is contraindicated in patients without an intact gallbladder, as well as inpatients with other high risk factors for pancreatitis, such as heavy alcohol use. This medication is also contraindicated in patients with severe hepatic impairment.

By having specific contraindications to this medication, I have a better understanding of who the appropriate patient should be for VIBERZI.

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Kim Orleck and the following disclaimer

Data from two randomized, parallel-group, multicenter, multinational, double-blind, placebo-controlled, Phase 3 clinical trials in IBS-D adult patients aged 18-80 years. A responder was defined as a patient with ≥30% reduction in daily abdominal pain AND improvement in daily stool consistency to <5 on the Bristol StoolScale. Improvement in abdominal pain in the absence of a bowel movement was also considered a response day. Responders saw simultaneous improvement of BOTH symptoms on at least 50% of days in the trial.

IBS-3002 (N=1145) measured VIBERZI 100 mg (recommended dose)(n=382) vs placebo (n=382). Primary endpoint: Weeks 1-12: Trt Diff13%, 95% CI (8%, 19%); P< 0.001. Secondary endpoint: Weeks 1-26: Trt Diff 13%, 95% CI (6%, 19%). IBS-3001 (N=1281) measured VIBERZI 100 mg (recommended dose) (n=426) vs placebo (n=427). Primary endpoint: Weeks 1-12: Trt Diff 8%, 95% CI (3%,14%); P< 0.01. Secondary endpoint: Weeks 1-26: Trt Diff 10%, 95%CI (5%, 16%).

KIM: Additionally, VIBERZI was studied in over 2400 adult patients with IBS-D and this medication has a well-studied safety profile, with the most common adverse events being constipation, nausea and abdominal pain. Some arms of the VIBERZI studies included a withdrawal period, and this showed no worsening of diarrhea or abdominal pain compared to baseline, if a patient decides to discontinue therapy for any reason. Thank You.

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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.