(el" ux ad' oh leen)

Brand Name(s): Viberzi^®

WHY is this medicine prescribed?

Eluxadoline is used to treat irritable bowel syndrome with diarrhea (IBS-D; a condition that causes stomach pain, cramping, or loose or watery stools) in adults. Eluxadoline is in a class of medications called mu-opioid receptor agonists. It works by decreasing bowel activity.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Eluxadoline comes as a tablet to take by mouth. It is usually taken with food twice daily. Take eluxadoline at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eluxadoline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Eluxadoline may be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking eluxadoline,

• tell your doctor and pharmacist if you are allergic to eluxadoline, any other medications, or any of the ingredients in eluxadoline tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alfentanil (Alfenta); alosetron (Lotronex); antibiotics such as ciprofloxacin (Cipro) and clarithromycin (Biaxin, in Prevpac); anticholinergic medications such as benztropine (Cogentin), dicyclomine (Bentyl), diphenhydramine (Benadryl); bupropion (Forfivo XL, Wellbutrin, Zyban, others); eltrombopag (Promacta); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine tartrate (Ergomar, in Cafergot, in Migergot); fentanyl (Abstral, Actiq, Duragesic, Sublimaze, others); fluconazole (Diflucan); gemfibrozil (Lopid); medications for HIV such as atazanavir (Reyataz, in Evotaz), lopinavir (Kaletra), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), and tipranavir (Aptivus); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus XR, Prograf); opiate (narcotic) medications for pain; paroxetine (Brisdelle, Paxil, Pexeva); pimozide (Orap); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); and rosuvastatin (Crestor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• you should know that you may take loperamide (Imodium AD) occasionally to treat severe diarrhea while taking eluxadoline. Stop taking loperamide immediately if you become constipated.

• tell your doctor if you have constipation now or if you often have constipation, if you drink or have ever drunk large amounts of alcohol (more than 3 alcoholic beverages a day), or if you do not have a gallbladder. Also tell your doctor if you have or have ever had bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine), sphincter of Oddi dysfunction (blockage of bile or digestive juices flowing into the intestine that causes pain or jaundice), blockage in your intestines, pancreatitis (swelling of the pancreas that does not go away), or liver disease. Your doctor will probably tell you not to take eluxadoline.

• tell your doctor if you have or have ever had kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking eluxadoline, call your doctor.

• you should know that eluxadoline may make you drowsy, especially if you have liver disease. Do not drive a car or operate machinery until you know how this medication affects you.

• tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time. Ask your doctor about the safe use of alcoholic beverages while you are taking eluxadoline. Drinking alcohol may increase the risk that you will develop pancreatitis.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it with food. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Eluxadoline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting

Some side effects can be serious. If you experience any of these symptoms, stop taking eluxadoline and call your doctor immediately or get emergency medical treatment:

• pain that begins in the upper stomach area but may spread to the back or shoulder with or without nausea and vomiting
• severe constipation
• rash; hives; swollen face or throat; shortness of breath; throat tightness; chest pain or tightness; or difficulty swallowing or breathing

Eluxadoline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Eluxadoline is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2020.