Eluxadoline

Avoid taking anti-diarrhea medicine such as loperamide (Imodium) without your doctor's advice. Taking loperamide long-term while you are taking eluxadoline may cause severe constipation.

Avoid drinking alcohol. It may increase your risk of pancreas problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• bronchodilators such as aclidinium, ipratropium, tiotropium, or umeclidinium;
• cold or allergy medicine that contains an antihistamine;
• medication for Parkinson's disease;
• medication to treat excess stomach acid, stomach ulcer, or motion sickness;
• narcotic medication; or
• other medications to treat irritable bowel syndrome.

This list is not complete. Other drugs may interact with eluxadoline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Eluxadoline is a prescription medication used to irritable bowel syndrome with diarrhea in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Eluxadoline is part of the drug class:

• Other drugs for functional gastrointestinal disorders

You should not use eluxadoline if you are allergic to it, or if you have:

• severe constipation or a blockage in your intestines;

• a history of gallbladder obstruction, or if your gallbladder has been removed;

• digestive problems caused by a muscle valve called the sphincter of Oddi (SFINK-ter of OD-dee);

• severe liver disease;

• a pancreas disorder; or

• a habit of drinking more than 3 alcoholic beverages per day.

To make sure eluxadoline is safe for you, tell your doctor if you have:

• liver disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether eluxadoline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Eluxadoline is not approved for use by anyone younger than 18 years old.

Mixed μ-opiate receptor agonist and δ-opiate receptor antagonist;1 2 3 4 5 6 has poor oral bioavailability and is used for its local effects at opiate receptors in the GI tract.2 3 4 6 8

• Mixed μ-opiate receptor agonist and δ-opiate receptor antagonist.1 2 3 4 5 6 Also exhibits agonist activity at κ-opiate receptor, but binding affinity for this receptor in humans not determined.1

• Has poor oral bioavailability and is used for its local effects at opiate receptors in the GI tract.2 3 4 6 8

• In animals, interacts with opiate receptors in the gut,1 5 reduces contractility in intestinal tissue, and inhibits neurogenically mediated secretion in vitro;4 5 normalizes GI transit and reduces fecal output in animal models of altered GI function.3 4 5 6 9

It is very important that your doctor check your progress at regular visits to make sure that eluxadoline is working properly and to check for unwanted effects.

If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.

Stop taking eluxadoline and call your doctor right away if you have constipation for more than 4 days.

eluxadoline may increase your risk for sphincter of Oddi spasm. This is more likely to occur if you do not have a gallbladder. Call your doctor right away if you have new or worsening stomach pain or pain in the upper right abdominal or stomach that may move to your back or shoulders, with or without nausea or vomiting.

eluxadoline may increase your risk for pancreatitis. Check with your doctor right away if you have the following symptoms: bloating, chills, darkened urine, sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness, or yellow eyes or skin.

If you have liver problems, do not drive or do anything that could be dangerous until you know how eluxadoline affects you.

Avoid drinking excessive alcohol while using eluxadoline.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If you have an allergy to eluxadoline or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: A problem with the part of your body that controls the flow of bile and pancreas juice to the small bowels (sphincter of Oddi), bile tract blockage, liver problems, or stomach or bowel blockage.
• If you do not have a gallbladder. The chance of very bad pancreatitis is higher in people who do not have a gallbladder. This could lead to having to go to the hospital or death.
• If you have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks per day.
• If you have ever had any of these health problems: Pancreas problems like blockage in your pancreas or pancreatitis, problems caused by constipation, or very bad or long-lasting constipation.
• If you are taking any of these drugs: Alosetron; loperamide; opioid drugs like oxycodone; or oxybutynin or other drugs like it.
• If you are taking any drugs that may cause constipation. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with eluxadoline.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Viberzi: 75 mg, 100 mg

Mean eluxadoline plasma exposure was 6-fold, 4-fold, and 16-fold higher in mild, moderate, and severe hepatically impaired subjects (Child Pugh Class A, B, C), respectively.

Irritable bowel syndrome with diarrhea: Oral: 100 mg twice daily; may decrease to 75 mg twice daily in patients unable to tolerate the 100 mg dose

Dosage adjustment for concomitant therapy: Coadministration of OATP1B1 inhibitors (eg, cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, saquinavir, tipranavir, rifampin, eltrombopag): 75 mg twice daily

Refer to adult dosing.

Mild (Child-Pugh class A) to moderate (Child-Pugh class B) impairment: 75 mg twice daily.

Severe impairment (Child-Pugh class C): Use is contraindicated.

Take with food

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

1% to 10%:

Central nervous system: Dizziness (3%), fatigue (3%), drowsiness (≤2%), euphoria (≤2%), intoxicated feeling (≤2%), sedation (≤2%)

Dermatologic: Skin rash (3%)

Gastrointestinal: Constipation (7% to 8%), nausea (7% to 8%), abdominal pain (6% to 7%), vomiting (4%), spasm of sphincter of Oddi (<1%; 1% to 4% in patients without a gallbladder), abdominal distention (3%), flatulence (3%), viral gastroenteritis (3%), gastroesophageal reflux disease (≤2%)

Hepatic: Increased serum ALT (2% to 3%), increased serum AST (≤2%)

Respiratory: Upper respiratory tract infection (5%), nasopharyngitis (4%), bronchitis (3%), asthma (≤2%), bronchospasm (≤2%), respiratory failure (≤2%), wheezing (≤2%)

<1% (Limited to important or life-threatening): Increased liver enzymes, pancreatitis

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience common cold symptoms or nausea. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), abdominal pain, constipation, or abdominal pain that moves to back or shoulder with or without nausea and vomiting (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.