Eluxadoline (Oral)

Overview

Eluxadoline is a medication used to help adults with irritable bowel syndrome to control the symptoms of diarrhea and pain in the abdominal area. As a mu-opoid receptor, it works by decreasing bowel activity, thus inhibiting diarrhea and reducing the level of pain that may accompany it. This medication is considered to be a complimentary therapy for patients who have not found success in treating symptoms with diet and lifestyle changes.

This medication is listed as a controlled substance and may be habit-forming. It is only available with a prescription. This medication is not indicated for use by patients with a previous history of gallbladder issues or for those without a gallbladder. Eluxadoline is not recommended for use by children.

Conditions Treated

  • Irritable Bowel Syndrome with Diarrhea

Type Of Medicine

  • Mu-opiod Receptor

Side Effects

Side effects have been known to occur with the use of Eluxadoline. If nausea or vomiting is severe or does not go away with continued treatment, the prescribing physician should be consulted. Severe side effects are rare, except in those with a previous history of gallbladder issues. Serious side effects of taking Eluxadoline include:

  • Pain in the upper stomach that may spread to the back or shoulder, which may or may not occur along with nausea or vomiting,
  • Constipation lasting more than four days
  • Pancreatitis, or
  • Muscle spasms in the digestive system.

Rare side effects include:

  • Accelerated heartbeat
  • Bloating
  • Chills
  • Constipation
  • Dark urine
  • Fever
  • Indigestion
  • Loss of appetite
  • Yellow eyes or skin

Most side effects will go away during the course of treatment, as the patient's body adjusts to the medication. Some effects can be prevented or managed with the assistance of a healthcare professional. Less common side effects are listed below:

  • Body aches
  • Congestion of the ear
  • Cough
  • Excess gas in the stomach or intestines
  • Full feeling
  • Headache
  • Labored breathing
  • Loss of the voice
  • Muscle aches
  • Passing gas
  • Rash
  • Sore throat
  • Stuffy or runny nose
  • Swelling of abdominal or stomach area
  • Tightness in the chest
  • Unusual tiredness or weakness

Additional side effects not listed here may also occur in certain patients. Any medical concerns or unusual effects should be discussed with the prescribing physician.

Dosage

As with any medication, Eluxadoline should only be used by the person it is prescribed to and should be used as directed and only for the period of time recommended by the prescribing physician. Eluxadoline is available as a tablet, which is generally taken twice per day, with food. A physician may recommend that one tablet is taken in the morning and another in the evening.

This medication comes with a medication guide, which lists additional information regarding proper dosing.

The dosage prescribed may be different for different patients, based on symptoms and strength of the medication. This medication should be taken per the directions listed on the label. Adults are generally prescribed 100 mg, twice per day, but may be prescribed 75mg, twice per day. If a 100mg dose is not well tolerated, it may be changed to a 75mg dose for the remainder of treatment. Taking Eluxadoline without food can cause gastrointestinal issues.

In the case of a missed dose, the missed dose should be skipped and the regular dosing schedule resumed. Taking a double dose could result in unwanted side effects. If an overdose is experienced, immediate medical attention should be sought.

Major Drug Interactions

Taking another drug, herb or nutritional supplement, whether it is prescribed or over the counter, along with Eluxadoline could lead to adverse effects. If another medication is currently being taken, the prescribing physician may ask the patient to stop taking it, amend the dose, or take other precautions to prevent an interaction. Patients should discuss any medications taken with the prescribing physician. Taking Eluxadoline with any of the medications listed below is generally not suggested and the risks of interaction should be weighed with the prescribing physician. Major drug interactions include, but are not limited to the following:

  • Anti-Malarial Drugs
  • Narcotic Drugs
  • Protease inhibitors and HIV Antivirals
  • Cyclosporine (Restasis or Restasis MultiDose)
  • Dihydroergotamine (DHE)
  • Eltrombopag (Promacta)
  • Flibric Acid
  • Flibanserin (Addyi)
  • Pimozide (Orap)
  • Rifampin
  • Rosuvastatin (Statin)
  • Sirolimus
  • Tacrolimus
  • Temsirolimus

Special instructions may be given for the use of alcohol or tobacco products while taking Eluxadoline. Nonprescription or prescription medications might be prescribed for short-term use by patients who experience severe diarrhea. Certain foods may also interact with this medication.

Warnings

Eluxadoline is not recommended for patients who do not have a gallbladder. Pancreatitis can occur in those without a gallbladder and this condition can lead to death. Inflammation of the pancreas usually occurs within the first week of treatment with Eluxadoline but can happen as soon as the first dose. The risk of pancreatitis increases with the consumption of more than 3 alcoholic drinks per day. Alcohol use should be limited while taking this medication.

A specific muscle spasm in the digestive system known as sphincter of Oddi spasm could cause new or worsening abdominal pain. These spasms occur most often in patients without a gallbladder and may lead to hospitalization. A spasm usually occurs within one week of treatment but may happen after one or two doses. Cases of sphincter of Oddi spasm generally do not occur after one month of treatment.

Due to the significant risks associated with taking Eluxadoline in patients with no gallbladder, the FDA has issued a specific warning, urging physicians to consider over-the-counter or prescription medications other than Eluxadoline to treat the symptoms of irritable bowel syndrome for those with a history of gallbladder problems.

Eluxadoline should be stopped immediately if any new or worsening stomach pain, or pain in the upper right portion of the abdomen occurs, with or without vomiting.

Patients with a history of chronic or severe constipation, a known mechanical GI obstruction or risk of bowel obstruction should be monitored closely while taking this medication.

Using Eluxadoline with Loperamide on a regular basis can lead to constipation. Loperamide should only be taken along with Eluxadoline periodically and under a physician's supervision. Patients who take Eluxadoline should also avoid taking medications such as opioids and anticholinergics while taking Eluxadoline that could cause constipation.

Allergic reactions have occurred after one or two doses of Eluxadoline. If any of the signs or symptoms of an allergic reaction occur, immediate emergency medical attention should be sought. Signs of an allergy include shortness of breath, swelling of the face, lips, mouth or tongue, itching, rash or hives.

Each Eluxadoline tablet contains inactive ingredients that could cause allergies. These ingredients include colloidal silicas, crospovidone, emulsifiers, sugar alcohols, magnesium stearate powder, and Opadry II (for film coating).

This medication should not be taken by patients with gallbladder problems, those with history of alcohol abuse or addiction, pancreatitis or other problems of the pancreas, severe liver problems, a history of bowel blockages or chronic or severe constipation.

Eluxadoline is considered to be a controlled substance and refills may be limited. In certain cases, this medication may be habit-forming. Those with a history of drug or alcohol abuse should discuss their medical history with the prescribing physician.

Patients who are pregnant, breastfeeding or plan to become pregnant should talk to their physician before taking Eluxadoline. There are no significant studies on the effect of Eluxadoline on unborn babies. This medication is generally considered to be acceptable for use during pregnancy, but safer alternatives may exist for use during treatment. It is not known whether Eluxadoline is secreted in breast milk, so the risks and benefits of taking this medication while breastfeeding should be discussed with the prescribing physician.

Eluxadoline should not be taken by children. No significant research has been conducted on the use of Eluxadoline by geriatric patients, and it should only be taken by patients to whom it is prescribed.

This medication may cause drowsiness. Until the effects of this medication are established, patients should refrain from driving, operating machinery or engaging in any activity that requires total concentration. Double doses should not be taken. If a dose is missed, it should be skipped and the regular medication schedule resumed.

Storage

Eluxadoline should be stored in a closed container, kept at room temperature and away from heat, moisture and direct light. This medication should not be frozen and should be kept out of the reach of children and pets. Storing this medication in a bathroom, or outside of its original container is not recommended.

Any excess medication should be disposed of properly and not flushed or recycled. The prescribing physician or another healthcare professional may provide specific guidance on the disposal of Eluxadoline.

Summary

Eluxadoline is an oral medication taken in the form of tablets to treat irritable bowel syndrome with diarrhea in adults. This medication is available by prescription and is considered to be a controlled substance, therefore refills may be limited. Eluxadoline works by decreasing bowel activity, which reduces stomach pain, cramping and loose or watery stools.

This medication is classified as a mu-opoid receptor. Because Eluxadoline has the potential to be habit forming, patients with a history of drug or alcohol abuse should discuss their medical history with the prescribing physician. Consuming more than 3 alcoholic beverages per day while taking this medication is not recommended.

Eluxadoline could be harmful to those with significant gallbladder issues and should not be taken by those without a gallbladder. Pancreatitis and a specific type of muscle spasm have been reported when Eluxadoline is used by patients without a gallbladder. These conditions could lead to hospitalization and death.

Most patients take Eluxadoline twice per day with food. The dosage prescribed depends on the symptoms of the patient and their medical history. This medication should be stopped and the patient should seek immediate medical attention if severe nausea or vomiting occurs, or if pain is experienced in the upper right abdominal area, potentially spreading to the shoulder and upper back. Severe side effects are not common, and generally subside as the body becomes tolerant of this medication.

Allergies to this medication and its non-effective ingredients have been reported. Patients who experience any of the symptoms of an allergic reaction should seek immediate medical attention. Eluxadoline should not be taken by children. Those who are pregnant, breastfeeding or plan to become pregnant should discuss this with the prescribing physician. Questions or concerns regarding the effects of Eluxadoline should be addressed to a medical professional.