Xermelo
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-12-2022
Fachinformation
(SPC)
12-12-2022
Öffentlichen Beurteilungsberichts
(PAR)
20-10-2017
Wirkstoff:
telotristat etiprate
Verfügbar ab:
SERB SAS
ATC-Code:
A16A
INN (Internationale Bezeichnung):
telotristat ethyl
Therapiegruppe:
Other alimentary tract and metabolism products
Therapiebereich:
Carcinoid Tumor; Neuroendocrine Tumors
Anwendungsgebiete:
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Produktbesonderheiten:
Revision: 15
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-09-17
Gebrauchsinformation
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XERMELO 250 MG FILM-COATED TABLETS
telotristat ethyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xermelo is and what it is used for
2.
What you need to know before you take Xermelo
3.
How to take Xermelo
4.
Possible side effects
5.
How to store Xermelo
6.
Contents of the pack and other information
1.
WHAT XERMELO IS AND WHAT IT IS USED FOR
WHAT XERMELO IS
This medicine contains the active substance telotristat ethyl.
WHAT XERMELO IS USED FOR
This medicine is used in adults with a condition called ‘carcinoid
syndrome’. This is when a tumour,
called a ‘neuroendocrine tumour’, releases a substance called
serotonin into your bloodstream.
Your doctor will prescribe this medicine if your diarrhoea is not well
controlled with injections of
other medicines called ‘somatostatin analogues’ (lanreotide or
octreotide). You should keep having
injections of these other medicines when taking Xermelo.
HOW XERMELO WORKS
When the tumour releases too much serotonin into your bloodstream you
can get diarrhoea.
This medicine works by reducing the amount of serotonin made by the
tumour. It will reduce your
diarrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XERMELO
DO NOT TAKE XERMELO
-
if you are allergic to telotristat or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xermelo:
•
if you have liver problems. This is because this m
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
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.
_ _
_Special population _
_ _
_Elderly _
_ _
No specific dose recommendations are available for elderly patients
(see section 5.2).
_ _
3
_Renal impairment _
_ _
No change in dose 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
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