Truberzi - Eluxadoline

What is Truberzi - Eluxadoline and what is it used for?

Truberzi is a medicine that acts on the digestive system. It is used to treat adults with irritable bowel syndrome with diarrhea. Irritable bowel syndrome is a chronic bowel disorder characterized by pain and discomfort in the abdominal (belly) region, bloating and altered bowel habits.

Truberzi contains the active ingredient eluxadoline.

How is Truberzi used - Eluxadoline?

Truberzi can only be obtained with a prescription. It is available as tablets containing 75 mg and 100 mg of eluxadoline. The recommended dose is 100 mg, taken with food in the morning and evening. In patients who develop bothersome side effects, the dose can be reduced to 75 mg, in the morning and in the evening.

How does Truberzi - Eluxadoline work?

Eluxadoline, the active ingredient in Truberzi, is an opioid receptor agonist. This means that it binds to opioid receptors and acts like the body's natural opioids, calming the waves of contraction along the digestive system. In this way, the food stays in the intestine longer, increasing the absorption of liquids and thus reducing diarrhea. Since eluxadoline is not absorbed into the blood and distributed throughout the body, its effects are mostly confined to the intestine.

What benefit has Truberzi - Eluxadoline shown during the studies?

Truberzi has been evaluated in two main studies involving more than 2,400 patients with irritable bowel syndrome with diarrhea. In both studies, Truberzi was compared with placebo (a dummy treatment) for more than 26 weeks of treatment. , during which patients kept a daily diary of their symptoms related to irritable bowel syndrome. Effectiveness was measured on the basis of an improvement of more than 30% in abdominal pain, together with the absence of very soft stools.

In the first study, efficacy was shown in 29% (125 out of 426) of patients taking 100 mg twice daily Truberzi, compared with 19% (81 out of 427) of patients taking placebo. According to study, symptoms improved in 33% (125 out of 382) of the patients taking Truberzi at a dose of 100 mg twice a day, compared with 20% (77 out of 382) of the patients taking placebo.

What are the risks associated with Truberzi - Eluxadoline?

The most common side effects with Truberzi (which may affect more than 5 in 100 people) are constipation, nausea (feeling sick) and abdominal pain. Serious side effects include pancreatitis (inflammation of the pancreas) and spasm of the sphincter of Oddi (a painful condition in which the flow of bile and digestive juices into the intestine is blocked). For a complete list of side effects reported with Truberzi, see package leaflet.

Truberzi should not be used in patients with liver disorders, patients at risk of pancreatitis (for example, who have had pancreatic problems or who drink excessive amounts of alcohol), patients who have had their gallbladder surgically removed or who suffer from of disorders related to the secretion of bile in the intestine and to those who have suffered from severe or long-term constipation or intestinal blockage. Truberzi must not be used in patients treated with a class of medicines known as potent OATP1B1 inhibitors (such as cyclosporine, a medicine that acts on the immune system). For the full list of restrictions, see the package leaflet.

Why has Truberzi - Eluxadoline been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Truberzi are modest, but there is an "unmet need for treatments for irritable bowel syndrome with diarrhea. Undesirable effects were limited mainly to "digestive system and, for the most part, minor. Therefore, the Committee decided that Truberzi's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Truberzi - Eluxadoline?

The recommendations and precautions to be observed by healthcare professionals and patients for Truberzi to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.

More information about Truberzi - Eluxadolina

For the complete version of Truberzi's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Truberzi therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

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