Viberzi

VIBERZI- eluxadoline tablet, film coated
Allergan, Inc.

1 INDICATIONS AND USAGE

VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

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 [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 Population s ( 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.

3 DOSAGE FORMS AND STRENGTHS

  • 75 mg tablets: capsule-shaped tablets are coated in pale-yellow to light tan color debossed with “FX75” on one side. Each tablet contains 75 mg eluxadoline.
  • 100 mg tablets: capsule-shaped tablets are coated in pink-orange to peach color debossed with “FX100” on one side. Each tablet contains 100 mg eluxadoline.

4 CONTRAINDICATIONS

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 Warnings and Precautions ( 5.1)].
  • 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 [see Warnings and Precautions ( 5.1)].
  • 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 [see Warnings and Precautions ( 5.1)].
  • With a known hypersensitivity reaction to VIBERZI [see Warnings and Precautions ( 5.3)].
  • With severe hepatic impairment (Child-Pugh Class C). These patients are at risk for significantly increased plasma concentrations of eluxadoline [see Use in Specific Populations ( 8.6)]
  • 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 [see Warnings and Precautions ( 5.4)].

5 WARNINGS AND PRECAUTIONS

5.1 Pancreatitis

Pancreatitis, with or without sphincter of Oddi spasm [see Warnings and Precautions ( 5.1) ], 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 [see Contraindications ( 4) ]. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some 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 [see Contraindications ( 4) ].

5.2 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 (e.g., biliary-type pain) in patients taking VIBERZI [see Adverse Reactions ( 6.1) ]. Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder [see Warnings and Precautions ( 5.1) ]. Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses. VIBERZI is contraindicated in patients without a gallbladder [see Contraindications ( 4) ].

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, (e.g. acute epigastric or biliary [i.e., right upper quadrant] 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 or sphincter of Oddi spasm while taking VIBERZI [see Contraindications ( 4) ].

5.3 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 [see Adverse Reactions ( 6.2)].

Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction [see Contraindications ( 4) ].

5.4 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 [see Adverse Reactions ( 6.1), Drug Interactions ( 7) ].

6 ADVERSE REACTIONS

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)]

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.