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Truberzi is a brand name for Eluxadoline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
Verbatim from this product's EMA label. Tap a section to expand.
Posology The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders. The recommended dose is 200 mg daily (one 100 mg tablet, twice daily). For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).
Elderly In principle, general dose recommendations also apply to patients aged 65 years and above. However, given the potential for increased sensitivity to experience undesirable effects, it may be considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily).
Medicinal product no longer authorised3 If this dosage is well tolerated, but not sufficiently effective, dosage may subsequently be increased to 200 mg daily (one 100 mg tablet twice daily). See section
Summary of the safety profile The most common adverse reactions (incidence of >5%) reported were constipation (7% and 8% of patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg and 100 mg respectively) and abdominal pain (6% and 7% of patients receiving 75 mg and 100 mg respectively).
8% of patients receiving 100 mg) may also occur. Tabulated list of adverse reactions The following adverse reactions considered related to eluxadoline treatment from clinical trials and spontaneous reporting are presented according to the MedDRA System Organ Classification and frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System organ class Common Uncommon Not known Immune system disorders Hypersensitivity6 Nervous system disorders Dizziness Somnolence1 Gastrointestinal disorders Constipation Nausea Abdominal pain2 Vomiting Flatulence Abdominal distention Gastroesophageal reflux disease4 Sphincter of Oddi spasm3 Pancreatitis Skin and subcutaneous tissue disorders Rash5 Investigations Increased ALT Increased AST 1“Somnolence” term includes: somnolence and sedation.
2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper. Medicinal product no longer authorised7 3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain (terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction).
4 “Gastrooesophageal reflux disease” term includes gastrooesophageal reflux disease, dyspepsia and gastritis. 5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
4. 2). Paediatric population The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established. No data are available. Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms severity.
Method of administration For oral use. 2). Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose. 1. • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use.
4). g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction. 4). g. due to cholecystectomy or agenesis). 4). g. cyclosporine) • A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction.
4). • Hepatic impairment (Child-Pugh Class A-C). 2). • A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction.
3) in patients taking eluxadoline. Serious cases resulting in hospitalization and death, primarily in patients without a gallbladder have been reported. 3). Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with eluxadoline and some patients developed symptoms even after one to two doses but cases of pancreatitis after longer duration of treatment have also been reported.
g. abdominal pain, that may radiate to the back or shoulder, nausea and vomiting. 8). All patients should be instructed not to use alcohol while on treatment with eluxadoline. 8). Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder.
1. • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use. 4). g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction. 4). g. due to cholecystectomy or agenesis).
4). g. cyclosporine) • A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction. 4). • Hepatic impairment (Child-Pugh Class A-C). 2). • A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
These patients may be at risk for severe complications of bowel obstruction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. swollen face and/or throat), dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing period. Description of selected adverse reactions Constipation Approximately 50% of constipation events occurred within the first 2 weeks of treatment.
Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline and there were no serious complications of constipation related to eluxadoline use in pivotal studies. 1% of patients receiving 75 mg and 2% of patients receiving 100 mg discontinued treatment or temporarily suspended dosing secondary to constipation, respectively, compared to <1% of patients treated with placebo.
4). Sphincter of Oddi spasm In clinical studies, events of sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain in 8 patients, pancreatitis in 1 patient and abdominal pain with lipase elevation less than 3 times the upper limit of normal in 1 patient.
80% (8/10) of sphincter of Oddi spasm events presented within the first week of treatment. All events resolved upon discontinuation of Truberzi, with symptoms typically improved by the following day. All events of sphincter of Oddi spasm occurred in patients without a gallbladder.
4). The occurrence of such events in patients with an intact biliary tract cannot be excluded. Pancreatitis Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies. Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of symptoms.
All pancreatic events, whether or not associated with sphincter of Oddi spasm, were retrospectively evaluated as mild, indicating an absence of organ failure and local or systemic complications. 4). 8%) were at least 75 years old. There was an overall increased frequency of adverse events in the older population compared to patients <65 years which was comparable across all treatment groups, including placebo.
The frequency of serious adverse events, gastrointestinal events, and events leading to discontinuation tended to be lower for the 75 mg dose compared to the 100 mg dose. Therefore, in this population, the 75 mg dose twice daily can be used.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare Medicinal product no longer authorised8 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with eluxadoline and some developed symptoms after one to two doses. Truberzi is contraindicated in patients without a gallbladder.
3). g. , right upper quadrant] pain) that may radiate to the back or shoulder, with or without nausea and vomiting. 3). Constipation Eluxadoline may cause constipation. 5). If patients develop severe constipation, they should be instructed to stop Truberzi and seek medical attention.
Risk of constipation with eluxadoline in patients with other IBS sub-types is unknown, but may be increased. Caution should be exercised when administering eluxadoline in IBS patients whose bowel habits vary over time. 8) in patients who may experience increased plasma levels, such as in patients with a genetic predisposition for poor function of OATP1B1 transporter.
7. 8). Drug dependence and potential for abuse Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability. […]