Loading…
Xermelo is a brand name for Telotristat Ethyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is 250 mg three times daily (tid). Available data suggest that clinical response is usually achieved within 12 weeks of treatment. It is recommended to reassess the benefit of continued therapy in a patient not responding within this time period.
Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded. 2). Missed doses In the event of a missed dose, patients should take their subsequent dose at the next scheduled time point.
Patients should not take a double dose to make up for a missed dose. 2). 2). As a precautionary measure, it is recommended that patients with severe renal impairment will be monitored for signs of reduced tolerability. The use of Xermelo is not recommended in patients with end-stage renal disease requiring dialysis (eGFR < 15 mL/min requiring dialysis) because efficacy and safety of Xermelo in these patients have not been established.
Hepatic impairment In patients with mild hepatic impairment (Child Pugh score A), it may be necessary to reduce the dose to 250 mg twice daily according to tolerability. In patients with moderate hepatic impairment (Child Pugh score B), it may be necessary to reduce the dose to 250 mg once daily according to tolerability.
2). Paediatric population There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome. 2).
Summary of the safety profile The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%). They were generally of mild or moderate intensity.
1% of patients (5/70). Tabulated list of adverse reactions Adverse reactions reported in a pooled safety dataset of 70 patients with carcinoid syndrome receiving telotristat ethyl 250 mg tid in combination with SSA therapy in placebo-controlled clinical studies are listed in Table 1.
Adverse reactions are listed by MedDRA body system organ class and by frequency using the following 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness Table 1 - Adverse reactions reported in patients treated with Xermelo System organ class Very common Common Uncommon Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Depression, depressed mood Nervous system disorders Headache Gastrointestinal disorders Abdominal paina, nausea Abdominal distension, constipation, flatulence Faecalomac, intestinal obstruction Hepatobiliary disorders Gamma- glutamyltransferase increasedb Alanine aminotransferase increased (ALT), aspartate aminotransferase increased (AST), blood alkaline phosphatase increased (ALP) General disorders and administration site conditions Fatigue Oedema peripheral, pyrexia a Abdominal pain (including upper and lower abdominal pain) 6 b Gamma-glutamyl transferase increased (including preferred terms of gamma-glutamyl transferase increased, gamma-glutamyl transferase, and liver function test abnormal / hepatic enzyme increased for which gamma-glutamyl transferase was increased).
8). Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended as clinically indicated. In patients with hepatic impairment, continuous monitoring for adverse reactions and worsening of liver function is recommended.
Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected. Therapy with telotristat should not be resumed unless the liver injury can be explained by another cause.
Constipation Telotristat reduces bowel movement (BM) frequency. Constipation was reported in patients using a higher dose (500 mg). Patients should be monitored for signs and symptoms of constipation. If constipation develops, the use of telotristat and other concomitant therapies affecting bowel motility should be re-evaluated.
8). Patients should be advised to report any symptoms of depression, depressed mood and decreased interest to their physicians. 4 Excipients Lactose Xermelo contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
c Faecaloma has only been observed in a clinical study at a dose of 500 mg tid (twice the recommended dose). Description of selected adverse reactions Hepatic enzymes elevations Elevations in ALT > 3 × upper limit of normal (ULN) or ALP > 2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg).
These have not been associated with concomitant elevations in total serum bilirubin. The increases were largely reversible on dose interruption or reduction, or recovered whilst maintaining treatment at the same dose. 4. 7%; 14/71). 2% in the placebo group (3/71).
4% (1/71) in the telotristat ethyl 250 mg and placebo groups, respectively. Most events were mild or moderate and did not limit study treatment. 2% of patients (3/71) in the placebo group. Serious constipation was observed in 3 patients treated with a higher dose (500 mg) in the overall safety population (239 patients).
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 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.