Braftovi

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

Encorafenib

Tillgänglig från:

Pierre Fabre Medicament

ATC-kod:

L01EC03

INN (International namn):

encorafenib

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

Melanoma; Colorectal Neoplasms

Terapeutiska indikationer:

Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy

Produktsammanfattning:

Revision: 11

Bemyndigande status:

Authorised

Tillstånd datum:

2018-09-19

Bipacksedel

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRAFTOVI 50 MG HARD CAPSULES
BRAFTOVI 75 MG HARD CAPSULES
encorafenib
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 Braftovi is and what it is used for
2.
What you need to know before you take Braftovi
3.
How to take Braftovi
4.
Possible side effects
5.
How to store Braftovi
6.
Contents of the pack and other information
1.
WHAT BRAFTOVI IS AND WHAT IT IS USED FOR
Braftovi is an anti-cancer medicine that contains the active substance
encorafenib. Changes
(mutations) in the BRAF gene can produce proteins that cause the
cancer to grow. Braftovi targets
proteins made from this changed BRAF gene.
It is used in combination with another medicine containing binimetinib
to treat adult patients with a
type of skin cancer called melanoma when it has
-
a particular change (mutation) in a gene responsible for producing a
protein called BRAF, and
-
spread to other parts of the body, or cannot be removed by surgery
When Braftovi is used in combination with binimetinib, which targets
another protein that stimulates
cancer cell growth, the combination slows down or stops the growth of
your cancer.
Braftovi is also used in combination with another medicine cetuximab,
to treat adult patients with a
type of large intestine cancer when it has
-
a particular change (mutation) in a gene responsible for producing a
protein called BRAF, and
-
spread to other parts of the body of patients who have been previously
treated with other
anti

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Braftovi 50 mg hard capsules
Braftovi 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Braftovi 50 mg hard capsules
Each hard capsule contains 50 mg of encorafenib.
Braftovi 75 mg hard capsules
Each hard capsule contains 75 mg of encorafenib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Braftovi 50 mg hard capsules
Orange opaque cap and flesh opaque body, printed with a stylised
“A” on the cap and “LGX
50mg”
on the body. The length of the capsule is approximately 22 mm.
Braftovi 75 mg hard capsules
Flesh coloured opaque cap and white opaque body, printed with a
stylised “A” on the cap and
“LGX 75mg” on the body. The length of the capsule is approximately
23 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Encorafenib is indicated:
- in combination with binimetinib for the treatment of adult patients
with unresectable or metastatic
melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
- in combination with cetuximab, for the treatment of adult patients
with metastatic colorectal cancer
(CRC) with a BRAF V600E mutation, who have received prior systemic
therapy (see sections 4.4 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Encorafenib treatment should be initiated and supervised under the
responsibility of a physician
experienced in the use of anticancer medicinal products.
Posology
_Melanoma _
The recommended dose of encorafenib is 450 mg (six 75 mg capsules)
once daily, when used in
combination with binimetinib.
3
_Colorectal cancer _
The recommended dose of encorafenib is 300 mg (four 75 mg capsules)
once daily, when used in
combination with cetuximab.
_Dose modification _
_ _
_Melanoma _
The management of adverse reactions may require dose reduction,
temporary interruption or treatment
discontinuation of encorafenib (see Tables 1, 3 and 4).
For information on the posology and recommended dose modifications of
binimetinib, see sec