VIDEO TRANSCRIPT
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VIBERZI logo
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Understanding the Safety Profile of 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:
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 discuss the safety profile of VIBERZI for patients with IBS-D. Let’s take a look at the data from the Phase 3 pivotal trials that can help clarify some common misconceptions.
Starting with adverse events, the table at the top of the page shows that, in VIBERZI clinical trials, the most common reactions reported in more than 2% of patients treated with VIBERZI and more frequently than placebo were constipation, nausea, abdominal pain, upper respiratory tract infection, vomiting, nasopharyngitis, abdominal distention, bronchitis, dizziness, flatulence, rash, increased alanine aminotransferase, fatigue, and viral gastroenteritis.1 Among patients taking the 75 mg or 100 mg dose of VIBERZI, 8% discontinued prematurely due to adverse reactions compared to 4% on placebo. The most common reasons for discontinuation due to adverse reactions were constipation (1% for 75 mg and 2% for 100 mg) and abdominal pain (1% for both 75 mg and 100 mg). With placebo, less than 1% of patients discontinued due to either constipation or abdominal pain.
Now, many prescribers like yourself ask about the potential for euphoria, intoxication, or withdrawal. The data from the pivotal trials provided helpful clarity.
The rate of euphoria was 0% with the 75 mg dose and 0.2% with the 100 mg dose. Reports of “feeling drunk” were similarly low—0.1% with 75 mg and 0.1% with 100 mg.1
For appropriate patients, VIBERZI offers a well-characterized efficacy and safety profile. Explore the site further to learn more about the VIBERZI safety profile and how to identify patients who are appropriate for treatment.
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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.
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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.
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
REFERENCE: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2024.
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VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
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.
- 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.
- 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.
- 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, 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.
The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
Please see full Prescribing Information.
