VIBERZI (eluxadoline) CIV | Official Physician Site
Time 2022-10-14 00:56:43Web Name: VIBERZI (eluxadoline) CIV | Official Physician Site
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Home About IBS-D Efficacy Efficacy Patient Identification Targets Receptors in GI Tract Safety Profile Prescribing VIBERZI Resources & Support Patient Savings Tools for Your Practice Registration For U.S. Healthcare Professionals Only Important SafetyInformation Prescribing
Information Patient Site Important Safety
Information Prescribing
Information Patient Site
For U.S. Healthcare Professionals Only About IBS-D Efficacy Efficacy Patient Identification Targets Receptors
in GI Tract Safety Profile Prescribing
VIBERZI Resources
& Support Patient Savings Tools for Your Practice Registration Be Proactive Against IBS-D See the impact that bothersome abdominal
pain and diarrhea have on your patients Next Next VIBERZI® provides relief that
lasts* by targeting the core
components of IBS-D:
abdominal pain and diarrhea† *Based on trial data of up to 6 months. Explore the efficacy > Previous Previous
VIBERZI® provides relief that
lasts* by targeting the core
components of IBS-D:
abdominal pain and diarrhea†
*Based on trial data of up to 6 months.
Explore the efficacy
†VIBERZI met the composite endpoint of improvement in both abdominal pain and diarrhea, measured throughout 12 and 26 weeks in >2400 adult IBSD patients. A composite responder was defined as a patient with ≥30% reduction in abdominal pain as compared to the baseline weekly average AND improvement in stool consistency to <5 on the Bristol Stool Scale on at least 50% of days throughout the treatment period. The proportion of patients who were combined responders to VIBERZI at each 4week interval was numerically higher than placebo as early as month 1 through month 6.1
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IMPORTANT SAFETY INFORMATION ContraindicationsVIBERZI 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 PrecautionsPancreatitis: 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 ReactionsThe most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
Indications and UsageVIBERZI (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
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 July 21, 2020. 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. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 2. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta, a mixed μ opioid receptor agonist/μ 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.
References: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 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. http://www.dea.gov/druginfo/ds.shtml. Accessed April 2, 2020.
References: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 2. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta, a mixed μ opioid receptor agonist/μ 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. Drug scheduling. United States Drug Enforcement Administration website. http://www.dea.gov/druginfo/ds.shtml. Accessed January 20, 2017.
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IMPORTANT SAFETY INFORMATION See More IMPORTANT SAFETY INFORMATION ContraindicationsVIBERZI 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 PrecautionsPancreatitis: 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 ReactionsThe most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
Indications and UsageVIBERZI (eluxadoline) CIV is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
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 July 21, 2020. 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. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 2. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta, a mixed μ opioid receptor agonist/μ 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.
References: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 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. http://www.dea.gov/druginfo/ds.shtml. Accessed April 2, 2020.
References: 1. VIBERZI (eluxadoline) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2018. 2. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta, a mixed μ opioid receptor agonist/μ 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. Drug scheduling. United States Drug Enforcement Administration website. http://www.dea.gov/druginfo/ds.shtml. Accessed January 20, 2017.
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