Drug Safety-related Labeling Changes (SrLC)

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VIBERZI (NDA-206940)

(ELUXADOLINE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/13/2018 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Constipation

Newly added subsection:

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.

6 Adverse Reactions

Additions and/or revisions underlined:

  • Hypersensitivity Reactions

  • Constipation

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Addition of the following:

  • stop VIBERZI and immediately call their health care provider if they experience severe constipation.

11/08/2017 (SUPPL-5)

Approved Drug Label (PDF)

4 Contraindications

(addition underlined)

•         With a known hypersensitivity reaction to VIBERZI

5 Warnings and Precautions

5.3 Hypersensitivity Reactions

 (new subsection added)

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.

Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

6 Adverse Reactions

(addition underlined)

•         Hypersensitivity

6.2 Postmarketing Experience

(new subsection added)

The following adverse reactions have been identified during post-approval use of VIBERZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity: anaphylaxis, angioedema (e.g. swollen face and throat), dyspnea, throat tightness, and chest pain/tightness.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(additions underlined)

What is the most important information I should know about VIBERZI? VIBERZI can cause serious side effects, including:

•         Serious allergic reactions. Serious allergic reactions have happened in some people after taking 1 or 2 doses of VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including:

 

o swelling of your face, lips, mouth or tongue   

o rash

o shortness of breath or other breathing problems

o hives

o itching

Do not take VIBERZI if you:

•         have had an allergic reaction to VIBERZI.

PATIENT COUNSELING INFORMATION

(addition underlined)

•         stop VIBERZI immediately and seek medical attention if symptoms of a hypersensitivity reaction develop

04/20/2017 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

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

5 Warnings and Precautions

5.1 Pancreatitis

(Additions and/or revisions are underlined)

Pancreatitis, with or without sphincter of Oddi spasm, 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.   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.

5.2 Sphincter of Oddi Spasm

(Additions and/or revisions are underlined)

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. 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. 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.

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,…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

 (Additions and/or revisions are underlined)

Instruct patients to:

  • stop VIBERZI immediately and seek medical attention if unusual or severe abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, develops

  • discontinue VIBERZI and call their health care provider if they experience severe constipation

MEDICATION GUIDE

(Additions and/or revisions are underlined)

What is the most important information I should know about VIBERZI?

VIBERZI can cause serious side effects, including:

  • Inflammation of the pancreas (pancreatitis). Pancreatitis has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI but can happen after 1 to 2 doses of VIBERZI

  • Sphincter of Oddi spasm. The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) to the first part of your small intestine. A sphincter of Oddi spasm can cause an increase in your liver and pancreas enzymes and inflammation of the pancreas (pancreatitis) that can cause sudden stomach-area (abdomen) pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment with VIBERZI but can happen after 1 or 2 doses of VIBERZI.

Stop taking VIBERZI right away and get emergency medical care if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting.

Do not take VIBERZI if you:

  • do not have a gallbladder

What are the possible side effects of VIBERZI?

The most common side effects of VIBERZI include: constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that is severe.

02/11/2016 (SUPPL-1)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Newly added section; please refer to label.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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