Posology : מינונים

4.2    Posology and method of administration

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.

Special population

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

Renal impairment
No specific study has been performed in patients with renal impairment.
Patients with mild or moderate renal impairment should be treated with caution. No specific dose recommendations are available for patients with mild or moderate renal impairment.

The use of Xermelo is not recommended in patients with severe renal impairment and in patients with end-stage renal disease requiring dialysis (see section 5.2).


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) (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).