TAFINLAR dabrafenib (as mesilate) 75 mg capsule bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

dabrafenib mesilate, Quantity: 88.88 mg (Equivalent: dabrafenib, Qty 75 mg)

Tersedia dari:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Nama Internasional):

dabrafenib mesilate

Bentuk farmasi:

Capsule

Komposisi:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; magnesium stearate; hypromellose; iron oxide red; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Rute administrasi :

Oral

Unit dalam paket:

28, 120

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Unresectable or metastatic melanoma,TAFINLAR in combination with trametinib is indicated for the treatment of patients with BRAFV600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,TAFINLAR as monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,Adjuvant treatment of melanoma,TAFINLAR in combination with trametinib, is indicated for the adjuvant treatment of patients with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.,Anaplastic thyroid cancer (ATC),TAFINLAR in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.,Non-small cell lung cancer (NSCLC),TAFINLAR in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.,Low-grade glioma,TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 5.1 Clinical studies).,High-grade glioma,TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 Clinical studies).

Ringkasan produk:

Visual Identification: Opaque size 1 dark pink capsules imprinted with the identifying codes "GS LHF" and "75 mg"; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2013-08-27

Selebaran informasi

TAFINLAR
®
_dabrafenib (as mesilate) capsules_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START USING TAFINLAR.
This leaflet answers some common
questions about TAFINLAR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TAFINLAR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAFINLAR IS
USED FOR
TAFINLAR capsules contain the
active ingredient dabrafenib.
TAFINLAR belongs to a group of
medicines called "selective BRAF-
inhibitors".
TAFINLAR can be used by itself or
in combination with another
medicine called MEKINIST
(containing trametinib).
IF YOU ARE TAKING THESE MEDICINES
TOGETHER, PLEASE READ THE
MEKINIST CONSUMER MEDICINE
INFORMATION AS WELL AS THIS ONE
CAREFULLY.
TAFINLAR is used to:
•
Treat types of:
-
skin cancers called melanoma
-
thyroid cancers called
anaplastic thyroid cancer
(ATC)
-
lung cancers called non-small
cell lung cancer (NSCLC)
that have spread to other parts of
the body.
•
Prevent melanoma from coming
back after the melanoma has been
removed by surgery.
All of these cancers have changes
(mutation) in a gene called "BRAF"
that may have caused your cancer to
develop. TAFINLAR targets proteins
made by the mutated BRAF gene and
slows down or stops the development
of your cancer.

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION - TAFINLAR

(DABRAFENIB) CAPSULES
1. NAME OF THE MEDICINE
Dabrafenib.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
TAFINLAR 50 mg capsules
Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of
dabrafenib.
TAFINLAR 75 mg capsules
Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of
dabrafenib.
EXCIPIENTS
For the list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
TAFINLAR 50 mg capsules
Opaque, size 2 hard capsule composed of a dark red body and dark red
cap containing a white to
slightly coloured solid. The capsule shells are imprinted with GS TEW
and 50 mg.
TAFINLAR 75 mg capsules
Opaque, size 1 hard capsule composed of a dark pink body and dark pink
cap containing a white to
slightly coloured solid. The capsule shells are imprinted with GS LHF
and 75 mg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Unresectable or metastatic melanoma
TAFINLAR in combination with trametinib is indicated for the treatment
of patients with
BRAFV600 mutation positive unresectable Stage III or metastatic (Stage
IV) melanoma.
TAFINLAR as monotherapy is indicated for the treatment of patients
with BRAF V600 mutation
positive unresectable Stage III or metastatic (Stage IV) melanoma.
Adjuvant treatment of melanoma
TAFINLAR in combination with trametinib, is indicated for the adjuvant
treatment of patients with
a BRAF V600 mutation and involvement of the lymph node(s), following
complete resection.
Anaplastic thyroid cancer (ATC)
TAFINLAR in combination with trametinib is indicated for the treatment
of patients with locally
advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF
V600 mutation and with no
satisfactory locoregional treatment options.
Non-small cell lung cancer (NSCLC)
TAFINLAR in combination with trametinib is indicated for the treatment
of patients with advanced
non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment with TAFINLAR should be i