Eluxadoline

Side effects, and when to stop

The following adverse reactions described below and elsewhere in the labeling include:

• Pancreatitis
• Sphincter of Oddi Spasm [ see Warnings and Precautions ( 5.2 )]
• Hypersensitivity Reactions
• Constipation

Who should not take it

VIBERZI is contraindicated in patients:

• Without a gallbladder. These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm
• With known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm.
• With alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day. These patients are at increased risk for acute pancreatitis.
• With a history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction. These patients are at increased risk for acute pancreatitis.
• With a known hypersensitivity reaction to VIBERZI.
• With severe hepatic impairment (Child-Pugh Class C). These patients are at risk for significantly increased plasma concentrations of eluxadoline
• With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction.

Other medicines and interactions

Tables 2 and 3 include drugs which demonstrated a clinically important drug interaction with VIBERZI or which potentially may result in clinically relevant interactions.

2 dosage and administration

The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food.

The recommended dosage of VIBERZI is 75 mg taken orally twice daily with food in patients:

• unable to tolerate the 100 mg dose of VIBERZI.
• receiving concomitant OATP1B1 inhibitors.
• with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
• with moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m 2 ); and in patients with end stage renal disease (ESRD) not yet on dialysis (eGFR less than 15 mL/min/1.73 m 2 ).

Discontinue VIBERZI in patients who develop severe constipation.

Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.