XERMELO Film-coated tablet Ref.[9179] Active ingredients: Telotristat

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. Therefore, intake of higher doses is not recommended (see section 5.2).

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.

Elderly patients (65 years of age and above)

No specific dose recommendations are available for elderly patients (see section 5.2).

Renal impairment

No change in dosage is required in patients with mild, moderate or severe renal impairment; who are not requiring dialysis (see section 5.2). 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 has 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. The use of telotristat is not recommended in patients with severe hepatic impairment (Child Pugh score C) as no data are available (see section 5.2).

Paediatric population

There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome.

Method of administration

Oral use.

Xermelo should be taken with food (see sections 5.1 and 5.2).

Symptoms

There is limited clinical experience with telotristat overdose in humans. Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.

Management of overdose

Treatment of an overdose should include general symptomatic management.

Shelf life: 48 months.

This medicinal product does not require any special storage conditions.

PVC/PCTFE/PVC/Al blister.

The blisters are packaged in a carton.

Pack sizes of 90 and 180 tablets. Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.