Important Safety Information and Indication
Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; structural diseases of the pancreas.
Alcoholism, alcohol abuse, alcohol addiction, or drink more than 3 alcoholic beverages per day.
Severe hepatic impairment.
A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Sphincter of Oddi Spasm:
There is a potential for increased risk of sphincter of Oddi spasm, resulting in pancreatitis
or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) with
VIBERZI. These events were reported in less than 1% of patients receiving VIBERZI in clinical trials.
Patients without a gallbladder are at increased risk. Consider alternative therapies before
using VIBERZI in patients without a gallbladder and evaluate the benefits and risks of VIBERZI in these patients.
Inform patients without a gallbladder that they may be at increased risk for symptoms
of sphincter of Oddi spasm, such as elevated liver transaminases associated with abdominal pain
or pancreatitis, especially during the first few weeks of treatment. Instruct patients to stop
VIBERZI and seek medical attention if they experience symptoms of sphincter of Oddi spasm.
There is a potential for increased risk of pancreatitis not associated with sphincter of Oddi spasm; such events were reported in less than 1% of patients receiving VIBERZI in clinical trials, and the majority were associated with excessive alcohol intake. All pancreatic events resolved upon discontinuation of 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, associated with elevations of pancreatic enzymes. Instruct patients to stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis.
The most commonly reported adverse reactions (incidence
>5% and greater than placebo) were constipation, nausea, and abdominal pain.
VIBERZI is indicated in adults for the treatment of irritable bowel
syndrome with diarrhea (IBS-D).
Please also see full Prescribing Information.