Viberzi

The active ingredient in Viberzi is eluxadoline.

Eluxadoline activates mu-opioid receptor agonists and kappa-opioid receptors while blocking delta-opioid receptor antagonists in the intestines. This mixed effect helps reduce bowel contractions, slows the movement of food through the intestines, and lowers the sensation of abdominal pain.

The result is better control over bowel movements and fewer episodes of diarrhea, which is especially helpful for patients with IBS-D.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Viberzi. However, the following is a synopsis of the general guidelines for the use of Viberzi:

• Viberzi is taken by mouth, usually twice daily, once in the morning and once in the evening.
• Take each dose with food to reduce the risk of side effects.
• Swallow the tablet whole with water; do not crush, chew, or split it.
• If you miss a dose, skip the missed dose and take your next dose at the scheduled time. Do not take extra medicine to make up for a missed one.
• Do not take more than the prescribed dose. Overuse can increase the risk of pancreatitis or severe constipation.
• Avoid drinking alcoholic beverages while taking Viberzi. Even small amounts of alcohol can raise your risk of pancreas inflammation.
• If you experience new or worsening abdominal pain, stop taking the medication and contact your healthcare provider immediately.

Some mild or common side effects of Viberzi include:

• Constipation.
• Nausea.
• Abdominal pain or stomach-area discomfort.
• Vomiting.
• Drowsiness.
• Dizziness.
• Gas or bloating.
• Bronchitis or upper respiratory tract infections.

Some individuals may experience serious side effects while using Viberzi. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Pancreatitis (inflammation of the pancreas): sudden or severe upper stomach pain, nausea, vomiting, or pain radiating to the back.
• Sphincter of Oddi spasm: severe stomach or chest pain, nausea, or vomiting.
• Severe constipation or blockage: little or no bowel movement, swelling, or abdominal pain.
• Allergic reactions: rash, itching, hives, or swelling of the face, lips, tongue, or throat.
• Liver problems: yellowing of the skin or eyes, dark urine, or unusual fatigue.

These are not all of the possible side effects of Viberzi. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Viberzi, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• No gallbladder.
• A history of pancreatitis or gallbladder disease.
• Liver problems.
• Problems with alcohol abuse, alcohol addiction, or you drink more than 3 alcoholic drinks a day.
• Severe constipation or bowel blockage.
• Sphincter of Oddi dysfunction.
• A known allergy to eluxadoline or any inactive ingredients in the medication.

Viberzi should not be used in individuals who:

• Do not have a gallbladder.
• Have or have had pancreatitis or pancreatic duct obstruction.
• Have severe liver impairment.
• Have a history of chronic or severe constipation.
• Have known bile duct obstruction.
• Consume more than three alcoholic drinks per day or have a history of alcohol abuse or excessive alcohol use.
• Allergic to eluxadoline or any component of the medication.

Viberzi may improve bowel consistency and reduce diarrhea within a few days of treatment. However, noticeable relief of abdominal pain or urgency can take one to two weeks. Your healthcare provider will reassess your response after several weeks to determine if the medication is effective for you.

When Viberzi is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong OATP1B1 inhibitors (such as cyclosporine or gemfibrozil) may increase Viberzi levels in the blood.
• Rifampin – may reduce the effectiveness of Viberzi.
• Eluxadoline with loperamide or other antidiarrheals can increase the risk of constipation.
• Rosuvastatin may increase the risk of muscle-related side effects.
• Opioid pain medications can increase the risk of severe constipation or blockage.
• Eltrombopag, alosetron (Lotronex), or other drugs that affect the intestines – may heighten gastrointestinal side effects.

Viberzi is available in the following dosage forms and strengths: 75 mg and 100 mg oral tablets. The usual adult dose is 100 mg twice daily with food.

A lower dose of 75 mg twice daily may be recommended for patients who cannot tolerate the higher dose or who have mild to moderate liver impairment.

Store at room temperature and keep out of reach of children.

Viberzi is manufactured by Allergan USA, Inc.

Currently, there is no generic version of Viberzi approved in the United States or Canada.

Do not stop taking Viberzi without consulting your healthcare provider. If you need to discontinue treatment due to side effects, your doctor will guide you on how to do so safely.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. There is limited information about the use of eluxadoline during pregnancy. Animal studies have not shown major risks, but human data are insufficient. Your healthcare provider will determine whether the benefits outweigh any potential risks to you or your baby.

It is not known whether eluxadoline passes into breast milk. Because of the potential for serious side effects in a nursing infant, your doctor may advise you to stop breastfeeding or choose an alternative treatment while taking Viberzi. Always discuss breastfeeding plans with your healthcare provider before starting or continuing this medication.