What is Truberzi and Eluxadolina 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 region (belly), swelling and altered bowel habits.
Truberzi contains the active ingredient eluxadolina.
How is Truberzi used - Eluxadolina?
Truberzi can only be obtained with a prescription. It is available as tablets containing 75 mg and 100 mg eluxadoline. The recommended dose is 100 mg, taken with food in the morning and evening. In patients who develop troublesome side effects, the dose can be reduced to 75 mg in the morning and in the evening.
How does Truberzi - Eluxadolina work?
Eluxadolina, 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 contraction waves along the digestive system. In this way, food remains in the intestine longer, increasing fluid absorption and thus reducing diarrhea. Since eluxadolina is not absorbed into the blood and distributed throughout the body, its effects are mostly confined to the intestine.
What benefit has Truberzi - Eluxadolina shown during the studies?
Truberzi has been evaluated in two main studies, conducted on more than 2, 400 patients suffering from 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. Efficacy 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 demonstrated in 29% (125 of 426) of patients taking Truberzi at a dose of 100 mg twice a day, compared to 19% (81 of 427) of patients taking placebo. In the second study, the symptoms improved in 33% (125 of 382) of patients taking Truberzi at a dose of 100 mg twice a day, compared to 20% (77 of 382) of patients taking placebo.
What are the risks associated with Truberzi - Eluxadolina?
The most common side effects of Truberzi (which may affect more than 5 people in 100) 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 in the intestine is blocked). For the full list of all side effects reported with Truberzi, see the 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 undergone surgical removal of the gallbladder or who suffer from of disorders related to bile secretion in the intestine and to those who have suffered from severe or long-term constipation or intestinal blockage. Truberzi should not be used in patients treated with a class of medicines known as potent OATP1B1 inhibitors (such as ciclosporin, a medicine that affects the immune system). For the full list of limitations, see the package leaflet.
Why has Truberzi - Eluxadolina been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Truberzi's benefits are modest, but there is an unmet need for treatments for irritable bowel syndrome with diarrhea. Undesirable effects were mainly limited to the digestive system and mostly mild. 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 - Eluxadolina?
Recommendations and precautions to be followed by healthcare professionals and patients for Truberzi to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information about Truberzi - Eluxadolina
For the full version of the EPAR of Truberzi, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Truberzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
