Details for: VIBERZI
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02460890 | VIBERZI | ELUXADOLINE | 75 MG | TABLET | ORAL |
| 02460904 | VIBERZI | ELUXADOLINE | 100 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Viberzi is used to treat adults with irritable bowel syndrome with diarrhea (IBS-D)
What it does
IBS-D is a bowel disorder which causes stomach discomfort, bloating and pain, along with diarrhea.
Viberzi acts on local receptors in the gut and may reduce diarrhea and may help reduce pain
Viberzi not a cure for IBS-D. If you stop taking Viberzi your symptoms may return in a week.
When it should not be used
Do not use Viberzi if you:
- Are allergic to any ingredient in Viberzi. Make sure to read “What are the ingredients in Viberzi?” above.
- have had a blockage in your bile duct (tube carrying bile from the liver and gallbladder to the intestine).
- have had a sphincter of Oddi problem (muscle that controls the flow of bile and pancreatic fluid into the intestine).
- do not have a gallbladder
- have had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day.
- have had pancreatitis (inflammation of the pancreas) or a blockage in your pancreas.
- have liver disease.
- have had long-lasting (chronic) or severe constipation.
- have had a bowel blockage (intestinal obstruction).
- are taking medicines which may increase the level of eluxadoline in your blood (e.g., OATP1B1 inhibitors such as cyclosporine).
What the medicinal ingredient is
eluxadoline
What the non-medicinal ingredients are
colloidal silica, crospovidone, mannitol, magnesium stearate, silicified microcrystalline cellulose, tablet coating (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide)
What dosage form it comes in
Viberzi is available in two tablet strengths, 75 mg and 100 mg
Warnings and precautions
Serious Warnings and Precautions
Pancreatitis (inflammation of the pancreas) may occur with Viberzi. Stop using Viberzi and get immediate medical help if you have new or worsening pain in your belly, with or without nausea or vomiting. The pain may feel like it is moving to your back or shoulder. See “Serious side effects and what to do about them”, below.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Viberzi. Talk about any health conditions or problems you may have, including if you:
- are pregnant or plan to become pregnant. Viberzi should not be used during pregnancy.
- are breastfeeding or plan to breastfeed. Viberzi should not be used when breastfeeding.
- have a history of illicit or prescription drug or alcohol abuse.
Other Warnings
- Constipation: Stop taking Viberzi and contact your doctor if you develop severe constipation. See “Serious side effects and what to do about them”, below.
- Drug Abuse and Dependence: Viberzi is an opioid. It may lead to psychological dependence or abuse. Use Viberzi only as directed by your doctor.
- Driving and Using machines: Viberzi may make you feel sleepy, dizzy or tired. Do not drive or operate machinery until these symptoms have passed.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Viberzi:
Some medicines may increase the level of eluxadoline in the blood for example:
- Cyclosporine (used to reduce inflammation).
- Gemfibrozil (used to lower lipid levels).
- Atazanavir, lopinavir, ritonavir or saquinavir (antiretrovirals used to treat HIV).
- Rifampin (antibiotic used to treat infections).
Do not take Viberzi with these medicines.
- Viberzi may increase the level of rosuvastatin (used to treat high cholesterol) in your blood. Talk to your doctor before taking Viberzi if you are taking rosuvastatin.
- Avoid taking Viberzi with drugs that cause constipation including opioids (e.g., fentanyl, oxycodone, hydrocodone, used to treat pain), anticholinergics (e.g., atropine used to treat heart disorders or oxybutynin or tolterodine, used to treat overactive bladder) or alosetron* (*not available in Canada).
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
- You may take loperamide occasionally with Viberzi to treat severe diarrhea. Stop taking loperamide right away if you become constipated.
- 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.
Proper use of this medication
How to take Viberzi:
Take Viberzi as prescribed by your healthcare professional.
Usual Dose
The usual adult dose is 100 mg (1 tablet) twice daily with food. Your healthcare professional may prescribe a lower dose of 75 mg twice daily with food, if you are 65 years of age or older or based on your medical history.
Overdose
Missed Dose
If you miss a dose of Viberzi (delay of > 4 hours), skip that dose and take the next dose at the usual time with food. Do not double your dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Viberzi. If you experience any side effects not listed here, contact your healthcare professional.
The most common side effects reported with Viberzi are:
- Constipation.
- Nausea.
- Abdominal pain.
- Vomiting.
- Bloating.
- Gas.
- Sleepiness.
- Dizziness.
- Fatigue.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| UNKNOWN | |||
| Severe constipation: may present with a difficulty passing stool, sudden belly pain, nausea, vomiting, and abdominal distention (feeling bloated or full). | ✔ | ||
| Allergic reactions: swelling of the face, lips, mouth or throat, shortness of breath or other breathing problems, itching, rash or hives | ✔ | ||
| RARE | |||
| Sphincter of Oddi spasm: new or worsening pain in the belly with or without nausea or vomiting. You may feel pain on the upper right side of your belly, just below the ribs. The pain may feel like it is moving to your back or shoulder. | ✔ | ||
| Pancreatitis: new or worsening pain in your belly, with or without nausea or vomiting. The pain may feel like it is moving to your back or shoulder. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store your bottle of pills at room temperature (15º to 30ºC). Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect;
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Viberzi:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.allergan.ca, or by calling 1-800-668-6424.
This leaflet was prepared by Allergan Inc
Last Revised: April 25, 2019
VIBERZI® is a registered trademark Allergan Holdings Unlimited Company, used under license by Allergan Inc.