1. Name of the medicinal product
Xermelo 250 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Excipient with known effect
Each tablet contains 168 mg of lactose (as anhydrous).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with 'T-E' debossed on one side and '250' debossed on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
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.
Elderly patients (65 years of age and above)
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 telotristat 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) 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).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Hepatic enzymes elevations
Elevations in hepatic enzymes were observed in clinical studies (see section 4.8). 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 events 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 s |
