Viberzi

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

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.

Eluxadoline works directly in your intestines to slow the movement of food during digestion. Eluxadoline also makes the nerves in your intestines less sensitive to stimulation.

Eluxadoline is used to treat irritable bowel syndrome when the main symptom is diarrhea.

Eluxadoline may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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;
• 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 also take alosetron (Lotronex);
• you have liver disease; or
• your gallbladder has been removed.

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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Irritable Bowel Syndrome

Management of irritable bowel syndrome (IBS) with diarrhea.1 4 8

Responses (reduced abdominal pain and improved stool consistency) observed in both male and female patients.1 8

Administration

Oral Administration

Administer twice daily with food.1

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

100 mg twice daily.1

75 mg twice daily in patients who cannot tolerate the 100-mg dosage, do not have a gallbladder, or are receiving concomitant therapy with an organic anion transporter protein (OATP) 1B1 inhibitor.1 (See Sphincter of Oddi Spasm and Associated Pancreatitis under Cautions and also see Drugs Affecting or Affected by OATPs under Interactions.)

Discontinue if severe constipation lasting >4 days develops.1

Special Populations

Hepatic Impairment

Mild or moderate hepatic impairment (Child-Pugh class A or B): 75 mg twice daily.1

Severe hepatic impairment (Child-Pugh class C): Contraindicated.1 (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

No specific dosage recommendations.1 (See Geriatric Use under Cautions.)

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction (because of increased risk for sphincter of Oddi spasm).1 (See Sphincter of Oddi Spasm and Associated Pancreatitis under Cautions.)

• Alcoholism, alcohol abuse or addiction, consumption of >3 alcoholic beverages per day, or history of pancreatitis or structural pancreatic disease, including known or suspected pancreatic duct obstruction (because of increased risk for acute pancreatitis).1 (See Pancreatitis Not Associated with Sphincter of Oddi Spasm under Cautions.)

• Severe hepatic impairment (Child-Pugh class C) (because of increased eluxadoline exposure).1 (See Special Populations under Pharmacokinetics.)

• History of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction (because of increased risk for severe complications of bowel obstruction).1

Warnings/Precautions

Sphincter of Oddi Spasm and Associated Pancreatitis

Potential for sphincter of Oddi spasm because of μ-opiate receptor agonist effects; spasm can result in pancreatitis or increases in hepatic enzyme concentrations associated with acute abdominal pain (e.g., biliary-type pain).1

Sphincter of Oddi spasm occurred in <1% of patients receiving eluxadoline in clinical studies.1 Spasm generally occurred within the first week of therapy and resolved upon drug discontinuance, with symptoms typically improved by the following day.1

Patients without a gallbladder are at an increased risk.1 Consider alternative therapies prior to initiating eluxadoline in patients without a gallbladder, and evaluate benefits and risks in the context of the patient's symptom severity.1 If decision is made to initiate eluxadoline, reduce dosage and monitor for signs and symptoms of sphincter of Oddi spasm (e.g., elevated hepatic aminotransferase concentrations associated with abdominal pain or pancreatitis), especially during the first few weeks of therapy.1 (See Dosage under Dosage and Administration and see Advice to Patients.)

Do not reinitiate in patients who develop biliary duct obstruction or sphincter of Oddi spasm while receiving the drug.1 (See Contraindications under Cautions.)

Pancreatitis Not Associated with Sphincter of Oddi Spasm

Possible increased risk of pancreatitis not associated with sphincter of Oddi spasm.1 Reported cases have resolved following drug discontinuance.1

Patients should avoid chronic or acute excessive alcohol consumption while receiving eluxadoline.1

Monitor patients for symptoms of pancreatitis (e.g., new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting).1 (See Contraindications under Cautions and see Advice to Patients.)

Dependence and Abuse

Subject to control as a schedule IV (C-IV) drug.1

Low incidence of euphoria or feelings of drunkenness (0–0.2%) in clinical trials at recommended dosages.1 In abuse-potential studies, supratherapeutic doses produced small but significant subjective responses (e.g., drug liking or disliking, high, dysphoria) and rates of euphoria (14–28%) that were intermediate to those produced by placebo (0–5%) or oxycodone (44–76%), suggesting potential for psychological dependence.1

In animal studies, discontinuance following chronic administration did not produce behavioral signs of withdrawal, but the drug appeared to be sufficiently self-rewarding to produce reinforcement.1

Specific Populations

No studies in pregnant women assessing eluxadoline-associated risks.1

No evidence of teratogenicity or adverse developmental effects in animals.1

Not known whether distributed into human milk; distributed into milk in rats.1

Consider benefits of breast-feeding and importance of the drug to the woman;1 also consider potential adverse effects on the breast-fed child from the drug or underlying maternal condition.1

Safety and efficacy not established in pediatric patients.1

No overall differences in efficacy or types of adverse effects relative to younger adults, but a higher proportion of geriatric patients experienced adverse effects, serious adverse effects, and adverse GI effects.1

Exposure to eluxadoline is increased in patients with hepatic impairment.1 (See Special Populations under Pharmacokinetics.)

Reduce dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); monitor patients with any degree of hepatic impairment for impairment of mental or physical abilities needed to perform potentially hazardous activities (e.g., driving, operating machinery) and for other eluxadoline-related adverse effects.1 (See Hepatic Impairment under Dosage and Administration.)

Contraindicated in patients with severe hepatic impairment; safety not established.1

Common Adverse Effects

Constipation,1 nausea,1 abdominal pain,1 upper respiratory tract infection,1 vomiting,1 nasopharyngitis,1 abdominal distention,1 bronchitis,1 dizziness,1 flatulence,1 rash,1 increased ALT concentrations,1 fatigue,1 viral gastroenteritis.1

It is very important that your doctor check your progress at regular visits to make sure that this medicine 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 this medicine and call your doctor right away if you have constipation for more than 4 days.

This medicine 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.

This medicine 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 this medicine affects you.

Avoid drinking excessive alcohol while using this medicine.

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bloating
• chills
• constipation
• darkened urine
• fast heartbeat
• fever
• indigestion
• loss of appetite
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• vomiting
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• chills
• cough
• cough producing mucus
• difficulty with breathing
• ear congestion
• excess air or gas in the stomach or intestines
• fever
• full feeling
• headache
• loss of voice
• muscle aches
• passing gas
• pressure in the stomach
• rash
• sneezing
• sore throat
• stuffy or runny nose
• swelling of abdominal or stomach area
• tightness in the chest
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Very hard stools (constipation).
• Stomach pain that is new or worse.
• Stomach pain that may move to your back or shoulder, with or without upset stomach or throwing up.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Viberzi (eluxadoline) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Viberzi or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Viberzi. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Viberzi is available as:

• 75 mg tablets: capsule-shaped tablets, coated in pale-yellow to light tan color, debossed with “FX75” on one side.
  Bottle of 60: NDC 61874-075-60
• 100 mg tablets: capsule-shaped tablets, coated in pink-orange to peach color, debossed with “FX100” on one side.
  Bottle of 60: NDC 61874-100-60

Store Viberzi tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].