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
