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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

 * Important Safety Information
 * Prescribing Information
 * Patient Site

 * About IBS-D
 * Efficacy Efficacy
   * Efficacy
   * Patient Journey
     and Identification
 * MOA
 * Safety Profile
 * Prescribing VIBERZI
 * Resources & Support Resources & Support
   * Tools for your
     Practice
   * IBS-D(ecoded)


RESOURCES & SUPPORT

for you and your staff, plus our IBS-Decoded podcast series, and access to
product samples and the VIBERZI patient savings program.
Access RESOURCES & SUPPORT
Are your adult IBS-D patients struggling with symptoms that occur unpredictably?
Patients with recurring abdominal pain and diarrhea have


NO TIME FOR IBS-D

SEE THE IMPACT OF IBS-D
Consider the


SYMPTOM RELIEF

that VIBERZI could bring to your adult IBS-D patients suffering from recurring
abdominal pain and diarrhea.
VIEW EFFICACY & SAFETY


RESOURCES & SUPPORT

for you and your staff, plus our IBS-Decoded podcast series, and access to
product samples and the VIBERZI patient savings program.
Access RESOURCES & SUPPORT
Are your adult IBS-D patients struggling with symptoms that occur unpredictably?
Patients with recurring abdominal pain and diarrhea have


NO TIME FOR IBS-D

SEE THE IMPACT OF IBS-D
Consider the


SYMPTOM RELIEF

that VIBERZI could bring to your adult IBS-D patients suffering from recurring
abdominal pain and diarrhea.
VIEW EFFICACY & SAFETY


RESOURCES & SUPPORT

for you and your staff, plus our IBS-Decoded podcast series, and access to
product samples and the VIBERZI patient savings program.
Access RESOURCES & SUPPORT


PATIENT SAVINGS PROGRAM

Savings cards available for your patients!

LEARN MORE >


VIBERZI SAMPLES

Free samples available for your patients!

ORDER HERE >

Not available where prohibited by law.


SUPPORT FOR YOU
& YOUR PATIENTS

Ongoing educational updates about IBS-D!

DISCOVER MORE >
IMPORTANT SAFETY INFORMATION
Indications and Usage

VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable
bowel syndrome with diarrhea (IBS-D).

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 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 also see full Prescribing Information.



REFERENCE: 1. VIBERZI (eluxadoline) [prescribing information). Madison, NJ:
Allergan USA, Inc.; 2018.

REFERENCES: 1. Grundmann O, Yoon SL. Irritable bowel syndrome: Epidemiology,
diagnosis and treatment: An update for health-care practitioners. J
Gastroenterol Hepatol. 2010;25:691-699. 2. Quick Facts-United States. United
States Census Bureau website.
https://www.census.gov/quickfacts/table/PST045215/00. Accessed November 10,
2022. 3. Shin A, Lembo A. IBS In America: Survey Summary Findings. American
Gastroenterological Association; 2015:1-45.

REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ:
Allergan USA, Inc.; 2018 2. Lembo AJ, Lacy BE, Zuckerman MJ, et al. Eluxadoline
for irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374(3):242-253;
S1-S13. 3. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller
RC. Functional bowel disorders. Gastroenterology. 2006;130(5):1480-1491. 4. Data
on file. Allergan USA, Inc.: 2018.

REFERENCES: 1. Shin A, Lembo A. IBS In America: Survey Summary Findings.
American Gastroenterological Association; 2015:1-45.

REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ:
AbbVie USA, Inc.; 2020 2. Data on file. Forest Laboratories, LLC.

REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ:
Allergan USA, Inc.; 2020. 2. Drug scheduling. United States Drug Enforcement
Administration website. https://www.dea.gov/drug-information/drug-scheduling.
Accessed May 19, 2023.

REFERENCES: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ:
Allergan USA, Inc.; 2020 2. Wade PR, Palmer JM, McKenney S, et al. Modulation of
gastrointestinal function by MuDelta, a mixed mu-opioid receptor agonist/
delta-opioid receptor antagonist. Br J Pharmacol. 2012;167(5):1111-1125. 3. Dove
LS, Lembo A, Randall CW, et al. Eluxadoline benefits patients with irritable
bowel syndrome with diarrhea in a phase 2 study. Gastroenterology.
2013;145:329-338.e1. 4. Lembo AJ, Lacy BE, Zuckerman MJ, et al. Eluxadoline for
irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374:242-253.

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Company, an AbbVie company.
© 2023 AbbVie. All rights reserved.

The information provided in this site is intended for U.S. healthcare
professionals only. The products described on this site may have different
product labeling in countries outside of the United States.

US-VBZ-220073   08/23

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION
Indications and Usage

VIBERZI® (eluxadoline) CIV is indicated in adults for the treatment of irritable
bowel syndrome with diarrhea (IBS-D).

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 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 also see full Prescribing Information.


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