Tabrecta

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

capmatinib dihydrochloride monohydrate

Διαθέσιμο από:

Novartis Europharm Limited 

Φαρμακολογική κατηγορία (ATC):

L01EX17

INN (Διεθνής Όνομα):

capmatinib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Carcinoma, Non-Small-Cell Lung

Θεραπευτικές ενδείξεις:

Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Περίληψη προϊόντος:

Revision: 1

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2022-06-20

Φύλλο οδηγιών χρήσης

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TABRECTA 150 MG FILM-COATED TABLETS
TABRECTA 200 MG FILM-COATED TABLETS
capmatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or
nurse.
-
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 Tabrecta is and what it is used for
2.
What you need to know before you take Tabrecta
3.
How to take Tabrecta
4.
Possible side effects
5.
How to store Tabrecta
6.
Contents of the pack and other information
1.
WHAT TABRECTA IS AND WHAT IT IS USED FOR
WHAT TABRECTA IS
Tabrecta contains the active substance capmatinib, which belongs to a
class of medicines called
protein kinase inhibitors.
WHAT TABRECTA IS USED FOR
Tabrecta is a medicine used to treat adults with a type of lung cancer
called non-small cell lung cancer
(NSCLC). It is used if the lung cancer is advanced or has spread to
other parts of the body (metastatic)
and is caused by a change (mutation) in a gene that makes an enzyme
called MET.
Your tumour or blood will be tested for certain mutations in this
gene. Your cancer is likely to respond
to treatment with Tabrecta if the test result is positive.
HOW TABRECTA WORKS
Tabrecta helps to slow down or stop the growth and spread of your lung
cancer if it is caused by a
mutation in a gene that makes MET.
If you have any questions about how Tabrecta works or

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Tabrecta 150 mg film-coated tablets
Tabrecta 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tabrecta 150 mg film-coated tablets
Each film-coated tablet contains capmatinib dihydrochloride
monohydrate equivalent to 150 mg
capmatinib.
Tabrecta 200 mg film-coated tablets
Each film-coated tablet contains capmatinib dihydrochloride
monohydrate equivalent to 200 mg
capmatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Tabrecta 150 mg film-coated tablets
Pale orange brown, ovaloid, curved film-coated tablet with bevelled
edges, unscored, debossed with
“DU” on one side and “NVR” on the other side. Approximate
size: 18.3 mm (length) x 7.3 mm
(width).
Tabrecta 200 mg film-coated tablets
Yellow, ovaloid, curved film-coated tablet
with bevelled edges, unscored, debossed with “LO” on one
side and “NVR” on the other side. Approximate size: 20.3 mm
(length) x 8.1 mm (width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tabrecta as monotherapy is indicated for the treatment of adult
patients with advanced non-small cell
lung cancer (NSCLC) harbouring alterations leading to
mesenchymal-epithelial transition factor gene
exon 14 (METex14) skipping, who require systemic therapy following
prior treatment with
immunotherapy and/or platinum-based chemotherapy.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Tabrecta should be initiated by a physician experienced
in the use of anticancer
therapies.
Patients have to be selected for treatment with Tabrecta based on the
presence of genetic alterations
leading to a METex14 skipping mutation in tumour tissue or plasma
specimens using a validated te