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 don’t see a lot of IBS-D patients.” appears.

AVO: “I don’t see a lot of IBS-D patients.”

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DR. ARIN NEWMAN AND HIS TITLE/LOCATION APPEARS

ARIN H. NEWMAN, MD

Gastroenterologist

MIAMI, FLORIDA

DR. NEWMAN: IBS-D is a chronic condition often with a relapsing remitting course. Some patients have symptoms on a weekly basis. Some have it more in a cyclical manner, where it improves over time and then gets worse during certain events, such as stressors or flare ups of comorbid conditions.

As many as 16 million U.S. adults have IBS-D, and it is important not to overlook their symptoms: the two most common being abdominal pain and diarrhea. A lot of times when patients come to the office, we’re focusing on other medical issues. And we tend to forget to ask them about GI symptoms. So, it is important at every visit that we ask if they are experiencing any abdominal symptoms such as: diarrhea, abdominal pain, bloating, and/or change of bowel habits.

IBS is a relatively straightforward diagnosis to make. Studies show that if you use the Rome criteria, and there are no alarm features present, approximately 99 percent of the time, you can accurately diagnose or rule out IBS-D.

At the time patients seek care from a medical provider, they’ve often been experiencing symptoms for years. On average, patients have already taken about 3.3 over-the-countertherapies for abdominal pain and diarrhea.

Patients may have tried changes in exercise, diet, vitamins, and supplements. On the other end of the spectrum, they may have tried antidiarrheals and prescription therapies such as antispasmodics and antidepressants.

IBS-D is a common condition seen by gastroenterologists. It's just a matter of asking the right questions, putting IBS-D on your radar, and really investigating symptoms to help your patients.
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.