Eluxadoline

What is Eluxadoline?

• Eluxadoline (Viberzi) is a mu-opioid receptor agonist used to treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

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What are the uses of this medicine?

• This medicine is used used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).
• Viberzi is a controlled substance (CIV) because it contains eluxadoline and may be abused or lead to drug dependence.
• Keep your Viberzi in a safe place, to protect it from theft.
• Never give your Viberzi to anyone else, because it may harm them. Selling or giving away this medicine is against the law.

How does this medicine work?

• Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist.
• The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively.
• The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM.
• In animals, eluxadoline interacts with opioid receptors in the gut.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• do not have a gallbladder.
• have or may have had a blockage in your gallbladder or a sphincter of Oddi problem.
• have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day.
• have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas.
• have had an allergic reaction to Viberzi.
• have severe liver problems.
• have had long-lasting (chronic) or severe constipation, or problems caused by constipation.
• have or may have had a bowel blockage (intestinal obstruction).

What drug interactions can this medicine cause?

• Avoid use with other drugs that may cause constipation ; loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use. Discontinue loperamide immediately if constipation occurs.(eg: alosetron, anticholinergics, opioids)
• Increased exposure to eluxadoline when coadministered with cyclosporine.
• Increased exposure to rosuvastatin when co-administered with Viberzi with a potential for increased risk of myopathy/rhabdomyolysis.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage in adults is 100 mg twice daily taken with food.

The recommended dosage is 75 mg twice daily taken with food in patients:

• unable to tolerate the 100 mg dose.
• are receiving concomitant OATP1B1 inhibitors.
• with mild or moderate hepatic impairment.
• with moderate or severe renal impairment; and in patients with end stage renal disease not yet on dialysis.
• Discontinue Viberzi in patients who develop severe constipation.
• If a dose is missed, take the next dose at the regular time; do not take 2 doses at once.

Administration

• Take Viberzi exactly as your doctor tells you to take it.
• Take 1 tablet of Viberzi 2 times each day with food.
• If you miss a dose, take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
• Do not change your dose or stop taking Viberzi unless your doctor tells you to.
• If you take too much Viberzi, call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 75 mg and 100 mg

This medicine is available in fallowing brand namesː

• Viberzi

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• abdominal pain

Viberzi can cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis)
• Sphincter of Oddi spasm
• Serious allergic reactions
• Constipation

What special precautions should I follow?

• Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of Viberzi. Monitor patients for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations; immediately discontinue Viberzi and seek medical attention if symptoms develop.
• Hypersensitivity reactions (including anaphylaxis) have been reported following Viberzi administration. Immediately discontinue Viberzi and seek medical attention if symptoms develop.
• Constipation, sometimes requiring hospitalization, has been reported following Viberzi administration. Instruct patients to stop Viberzi and immediately contact their healthcare provider if they develop severe constipation. Avoid use with other drugs that may cause constipation.

What to do in case of emergency/overdose?

• No reports of overdosage with Viberzi have been reported.

Management for overdosage:

• In the event of acute overdose, the stomach should be emptied and adequate hydration maintained.
• The patient should be carefully observed and given standard supportive treatment as required.
• Given eluxadoline’s action at opioid receptors, administration of a narcotic mu-opioid antagonist, such as naloxone, should be considered.
• Considering the short half-life of naloxone, repeated administration may be necessary.
• In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.

Can this medicine be used in pregnancy?

• There are no studies with Viberzi in pregnant women that inform any drug-associated risks.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: eluxadoline
• Inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).

Who manufactures and distributes this medicine?

• Distributed by: Allergan USA, Inc. Madison, NJ

What should I know about storage and disposal of this medication?

• Store Viberzi at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Viberzi and all medicines out of the reach of children.

• Dailymed label info on Eluxadoline
• FDA Eluxadoline

Eluxadoline Resources
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