What is VIBERZI? | VIBERZI (eluxadoline) CIV

VIBERZI is a prescription medicine that helps you proactively manage IBS-D abdominal pain and diarrhea

Taken every day, as prescribed by your healthcare provider, VIBERZI may provide continued symptom relief. VIBERZI has been shown to reduce abdominal pain and to make stools less loose and watery. In clinical trials, VIBERZI helped people get Irritable Bowel Syndrome with Diarrhea (IBS-D) symptoms under control—and kept them under control.

VIBERZI has been shown to relieve the 2 main symptoms of IBS-D at the same time:

REDUCES Abdominal Pain

REDUCES Diarrhea

VIBERZI works in your intestine

VIBERZI is the first and only prescription therapy in a different class of medicine for IBS-D. VIBERZI acts directly in the intestine to treat abdominal pain and diarrhea.*

Reduces nerve sensitivity in the intestine

Slows the movement of food through the colon

*This was seen in animal studies and the relevance to humans is not known.

Safety of VIBERZI

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 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.

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: swelling of your face, lips, mouth or tongue; shortness of breath or other breathing problems; itching, rash, or hives.
Constipation, including severe constipation that can lead to hospitalization, has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.

Do not take VIBERZI if you:

Do not have a gallbladder
Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem
Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day
Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas
Have had an allergic reaction to VIBERZI
Have severe liver problems
Have had long-lasting (chronic) or severe constipation, or problems caused by constipation
Have or may have had a bowel blockage (intestinal obstruction)

Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you have liver problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you are taking VIBERZI you should not take medicines that cause constipation, including Lotronex^® (alosetron), anticholinergic medicines, and opioid pain medicines.

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. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

For further information, please talk to your healthcare professional.

US-VBZ-230025

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (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. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal 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, but can happen after 1 to 2 doses of VIBERZI.

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: swelling of your face, lips, mouth or tongue; shortness of breath or other breathing problems; itching, rash, or hives.
Constipation, including severe constipation that can lead to hospitalization, has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.

Do not take VIBERZI if you:

Do not have a gallbladder
Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem
Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day
Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas
Have had an allergic reaction to VIBERZI
Have severe liver problems
Have had long-lasting (chronic) or severe constipation, or problems caused by constipation
Have or may have had a bowel blockage (intestinal obstruction)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

For further information, please talk to your healthcare professional.

US-VBZ-230025