Tafinlar

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

dabrafenib mesilate

Διαθέσιμο από:

Novartis Europharm Limited

Φαρμακολογική κατηγορία (ATC):

L01EC02

INN (Διεθνής Όνομα):

dabrafenib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Melanoma

Θεραπευτικές ενδείξεις:

MelanomaDabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).Adjuvant treatment of melanomaDabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.Non-small cell lung cancer (NSCLC)Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

Περίληψη προϊόντος:

Revision: 29

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-08-26

Φύλλο οδηγιών χρήσης

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAFINLAR 50 MG HARD CAPSULES
TAFINLAR 75 MG HARD CAPSULES
dabrafenib
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 Tafinlar is and what it is used for
2.
What you need to know before you take Tafinlar
3.
How to take Tafinlar
4.
Possible side effects
5.
How to store Tafinlar
6.
Contents of the pack and other information
1.
WHAT TAFINLAR IS AND WHAT IT IS USED FOR
Tafinlar is a medicine that contains the active substance dabrafenib.
It is used either on its own or in
combination with another medicine containing trametinib in adults to
treat a type of skin cancer called
melanoma that has spread to other parts of the body, or cannot be
removed by surgery.
Tafinlar in combination with trametinib is also used to prevent
melanoma from coming back after it
has been removed by surgery.
Tafinlar in combination with trametinib is also used to treat a type
of lung cancer called non-small cell
lung cancer (NSCLC).
Both cancers have a particular change (mutation) in a gene called BRAF
at the V600 position. This
mutation in the gene may have caused the cancer to develop. Your
medicine targets proteins made
from this mutated gene and slows down or stops the development of your
cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAFINLAR
Tafinlar should only be used to treat melanomas and NSCLC with the
BRAF mutation. Therefore
before starting treatment your doctor will test for this mutation.
If your doctor decides that you will

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tafinlar 50 mg hard capsules
Tafinlar 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tafinlar 50 mg hard capsules
Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of
dabrafenib.
Tafinlar 75 mg hard capsules
Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of
dabrafenib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Tafinlar 50 mg hard capsules
Opaque dark red capsules, approximately 18 mm long, with capsule shell
imprinted with “GS TEW”
and “50 mg”.
Tafinlar 75 mg hard capsules
Opaque dark pink capsules, approximately 19 mm long, with capsule
shell imprinted with “GS LHF”
and “75 mg”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
Dabrafenib as monotherapy or in combination with trametinib is
indicated for the treatment of adult
patients with unresectable or metastatic melanoma with a BRAF V600
mutation (see sections 4.4
and 5.1).
Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the
adjuvant treatment of adult patients
with Stage III melanoma with a BRAF V600 mutation, following complete
resection.
Non-small cell lung cancer (NSCLC)
Dabrafenib in combination with trametinib is indicated for the
treatment of adult patients with
advanced non-small cell lung cancer with a BRAF V600 mutation.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with dabrafenib should be initiated and supervised by a
qualified physician experienced in
the use of anticancer medicinal products.
Before taking dabrafenib, patients must have confirmation of tumour
BRAF V600 mutation using a
validated test.
The efficacy and safety of dabrafenib have not been established in
patients with wild-type BRAF
melanoma or wild-type BRAF NSCLC. Dabrafenib should therefore not be
used in patients with
wild-type BRAF melanoma or wild-type BRAF NSCLC (see sections 4.4 and
5.1).
Posology
The recommended