VIBERZI

Following oral administration of 100 mg VIBERZI in healthy subjects, the C max of eluxadoline was approximately 2 to 4 ng/mL and AUC was 12 to 22 ng.h/mL. Eluxadoline has approximately linear pharmacokinetics with no accumulation upon repeated twice daily dosing. The variability of eluxadoline pharmacokinetic parameters ranges from 51% to 98%.

AbsorptionAbsolute bioavailability of eluxadoline has not been determined. Effect of Food The median T max value was 1.5 hours (range: 1 to 8 hours) unde...

The efficacy and safety of VIBERZI in IBS-D patients was established in two randomized, multi-center, multi-national, double-blind, placebo-controlled trials (Studies 1 and 2). A total of 1281 patients in Study 1 and 1145 patients in Study 2 received treatment with VIBERZI 75 mg, VIBERZI 100 mg or placebo twice daily [overall, patients had a mean age of 45 years (range 18 to 80 years with 10% at least 65 years of age or older), 66% female, 86% white, 11% black, and 27% Hispanic]. All patients met Rome III criteria for IBS-D (loose [mushy] or watery stools ≥25% and hard or lumpy stools <25% of ...

The following adverse reactions described below and elsewhere in the labeling include: Pancreatitis [see Warnings and Precautions ( 5.1 )] Sphincter of Oddi Spasm [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Constipation [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) are constipation, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1- 800-678-1605 or FDA at 1-800-F...

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 [see Warnings and Precautions ( 5.1 , 5.2 )] 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 [see War...

Pancreatitis and Sphincter of Oddi Spasm : Monitor patients for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations; immediately discontinue VIBERZI and seek medical attention if symptoms develop. ( 5.1 , 5.2 ) Hypersensitivity Reactions, including anaphylaxis : Immediately discontinue VIBERZI and seek medical attention if symptoms develop. ( 4 , 5.3 ) Constipation: Instruct patients to stop VIBERZI and immediatel...

7 DRUG 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.

Table 2Established and Other Potentially Clinically Relevant Interactions Affecting VIBERZI OATP1B1 Inhibitors Clinical Impact: Increased exposure to eluxadoline when coadministered with cyclosporine [ see Cl...