MEKINIST trametinib 2 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trametinib dimethyl sulfoxide, Quantity: 2.254 mg (Equivalent: trametinib, Qty 2 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Trametinib dimethyl sulfoxide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; hypromellose; titanium dioxide; polysorbate 80; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

7, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Unresectable or metastatic melanoma,MEKINIST in combination with dabrafenib is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,MEKINIST as a monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is intolerance to BRAF inhibitors or BRAF inhibitors cannot be used.,MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on BRAF inhibitor therapy (see section 5.1 Clinical Trials).,Adjuvant treatment of melanoma,MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.,Anaplastic thyroid cancer (ATC),MEKINIST in combination with dabrafenib 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),MEKINIST in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.,Low-grade glioma,Mekinist in combination with dabrafenib 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,Mekinist in combination with dabrafenib 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). .

Product summary:

Visual Identification: MEKINIST 2 mg tablets are pink, round, biconvex, film-coated tablets with GS debossed on one face and HMJ on the opposing face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-02-14

Patient Information leaflet

MEKINIST
®
_trametinib (as dimethyl sulfoxide) tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START USING MEKINIST.
This leaflet answers some common
questions about MEKINIST
(trametinib). 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 Consumer
Medicine Information 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 MEKINIST
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 MEKINIST IS
USED FOR
MEKINIST tablets contain the active
ingredient trametinib. MEKINIST
belongs to a group of medicines
called "selective MEK-inhibitors".
MEKINIST can be used by itself or
in combination with another
medicine called TAFINLAR
IF YOU ARE TAKING THESE TWO
MEDICINES TOGETHER, READ THE FULL
TAFINLAR CONSUMER MEDICINE
INFORMATION AS WELL AS THIS ONE
CAREFULLY.
MEKINIST is used to:
•
treat types of:
-
thyroid cancers called
anaplastic thyroid cancer
(ATC)
-
lung cancers called non-small
cell lung cancer (NSCLC)
-
skin cancers called melanoma
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 a change
(mutation) in a gene called "BRAF"
that may have caused the cancer to
develop. MEKINIST targets proteins
made from this changed gene and
slows down or stops the development

Summary of Product characteristics

Page 1 of 44
AUSTRALIAN PRODUCT INFORMATION - MEKINIST

(TRAMETINIB) TABLETS
1 NAME OF THE MEDICINE
Trametinib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
MEKINIST 0.5 mg film coated tablet
Each film coated tablet contains trametinib dimethyl sulfoxide
equivalent to trametinib 500
micrograms.
MEKINIST 2 mg film coated tablet
Each film coated tablet contains trametinib dimethyl sulfoxide
equivalent to trametinib 2 mg.
EXCIPIENTS
For the list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
MEKINIST 0.5 mg film coated tablet
Yellow, modified oval, biconvex, film-coated tablets with ‘GS’
debossed on one face and ‘TFC’
on the opposing face.
MEKINIST 2 mg film coated tablet
Pink, round, biconvex, film-coated tablets with ‘GS’ debossed on
one face and ‘HMJ’ on the
opposing face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Unresectable or metastatic melanoma
MEKINIST in combination with dabrafenib is indicated for the treatment
of patients with BRAF
V600 mutation positive unresectable Stage III or metastatic (Stage IV)
melanoma.
MEKINIST as a monotherapy is indicated for the treatment of patients
with BRAF V600 mutation
positive unresectable Stage III or metastatic (Stage IV) melanoma and
in whom either there is
intolerance to BRAF inhibitors or BRAF inhibitors cannot be used.
MEKINIST as monotherapy has not demonstrated clinical activity in
patients who have progressed
on BRAF inhibitor therapy (see section 5.1 Clinical Trials).
Adjuvant treatment of melanoma
MEKINIST in combination with dabrafenib is indicated for the adjuvant
treatment of patients with
melanoma with a BRAF V600 mutation and involvement of the lymph
node(s), following complete
resection.
Anaplastic thyroid cancer (ATC)
MEKINIST in combination with dabrafenib 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.
Page 2 of 44
Non-small cell lung ca