Eluxadoline, Oral

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KEY POINTS

• This medicine is taken by mouth to irritable bowel syndrome when the main problem is severe diarrhea. Take it exactly as directed.
• This medicine may cause severe side effects in your pancreas or intestines, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: mu-opioid receptor agonist

Generic and brand names: eluxadoline, oral; Viberzi

What is this medicine used for?

This medicine is taken by mouth to treat irritable bowel syndrome when the main problem is severe diarrhea.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Sphincter of Oddi spasms (The sphincter of Oddi is a valve that controls the flow of digestive juices from the liver and pancreas to the first part of your intestine.)
• Gallbladder problems
• Liver disease
• Pancreatitis or other problems with your pancreas
• Problems with alcohol abuse (Tell your healthcare provider if you have more than 3 alcoholic drinks a day.)

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Ask your healthcare provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you become constipated, or have bloody diarrhea, rectal bleeding, or new or worsening stomach pain while taking this medicine, stop taking the medicine and contact your healthcare provider right away. These may be signs of very serious side effects.

Do not use any medicines to treat constipation or diarrhea without your healthcare provider’s approval.

You need to see your provider regularly to check your progress and see if your dosage needs to be adjusted. Keep all appointments. Contact your healthcare provider if your condition does not improve or if it gets worse.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert and you know how this medicine affects you.

Do not drink alcohol unless your healthcare provider approves. Drinking alcohol while taking this medicine may increase your risk of pancreatitis. Contact your healthcare provider right away if you have new or worsening stomach pain that may move to your back or shoulder, with or without nausea and vomiting.

Adults over the age of 65 may be at greater risk for side effects. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Constipation that lasts more than 4 days; rectal bleeding; bloody or severe diarrhea, new or worsening stomach pain that may spread to the back or shoulder, with or without nausea and vomiting; trouble breathing.

Other: Mild nausea, vomiting, or stomach pain; tiredness; bloating; heartburn; gas; headache; rash; itching; runny or stuffy nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alosetron (Lotronex)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), ofloxacin, rifampin (Rifadin), and telithromycin (Ketek)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as fluoxetine (Prozac), fluvoxamine (Luvox), and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), and rosuvastatin (Crestor)
• Conivaptan (Vaprisol)
• Eltrombopag (Promacta)
• HIV medicines such as atazanavir (Reyataz), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Loperamide (Imodium)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pimozide (Orap)
• Quinidine or dextromethorphan/quinidine (Nuedexta)
• Simeprevir (Olysio)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Do not share medicines with other people.