XERMELO 250 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

TELOTRISTAT ETHYL AS ETIPRATE

Commercializzato da:

MEDISON PHARMA LTD

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

TELOTRISTAT ETHYL AS ETIPRATE 250 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

IPSEN PHARMA, FRANCE

Indicazioni terapeutiche:

Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

Data dell'autorizzazione:

2019-03-18

Foglio illustrativo

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
XERMELO 250 MG
FILM-COATED TABLETS
EACH FILM-COATED
TABLET CONTAINS:
TELOTRISTAT ETHYL (AS ETIPRATE) 250 MG
Inactive ingredients and allergens in this medicine - see section 6
‘ADDITIONAL
INFORMATION’. See also ‘IMPORTANT INFORMATION ABOUT SOME OF THIS
MEDICINE’S
INGREDIENTS’ in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Xermelo in combination with a somatostatin analogs (SSA) is used to
treat adults who
have diarrhea associated with a condition called carcinoid syndrome,
when their diarrhea is
not sufficiently well controlled with somatostatin analog treatment.
THERAPEUTIC GROUP: substances that affect the digestive system and
metabolism.
This medicine is used to treat adults with a condition called
carcinoid syndrome. In this
condition, a tumor, called a ‘neuroendocrine tumor’, releases a
substance called serotonin
into your bloodstream. When the tumor releases too much serotonin into
your bloodstream
you can get diarrhea. This medicine works by reducing the amount of
serotonin made by
the tumor, and this reduces the diarrhea you have.
Your doctor will prescribe this medicine if your diarrhea is not
sufficiently well
controlled
with injections of other medicines called ‘somatostatin analogs’
(lanreotide or octreotide).
You must keep having injections of these other medicines when taking
Xermelo.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (telotristat
ethyl) or to any of
the other ingredient

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xermelo
®
250 mg
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 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 patients _
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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.