VIBERZI Film-coated tablet Ref.[27436] Active ingredients: Eluxadoline

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 [see Adverse Reactions (6.1)].
• receiving concomitant OATP1B1 inhibitors [see Drug Interactions (7)].
• with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment [see Use in Specific Populations (8.6)].
• with moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m²); and in patients with end stage renal disease (ESRD) not yet on dialysis (eGFR less than 15 mL/min/1.73 m²) [see Use in Specific Populations (8.7)].

Discontinue VIBERZI in patients who develop severe constipation [see Warnings and Precautions (5.4)].

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.

No reports of overdosage with VIBERZI have been reported.

In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. The patient should be carefully observed and given standard supportive treatment as required. Given eluxadoline’s action at opioid receptors, administration of a narcotic mu-opioid antagonist, such as naloxone, should be considered. Considering the short half-life of naloxone, repeated administration may be necessary. In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.

Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].