Mekinist

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5 mg;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Trametinib dimethyl sulfoxide 0.5635 mg (= trametinib 0.5 mg)

Dosage:

0.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5 mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Magnesium stearate Mannitol Microcrystalline cellulose Opadry yellow 03B120006 Purified water Sodium laurilsulfate

Prescription type:

Prescription

Manufactured by:

Glaxo Wellcome Manufacturing Pte Ltd

Therapeutic indications:

MEKINIST in combination with dabrafenib is indicated for the treatment of patients with BRAFV600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma. MEKINIST as a monotherapy is indicated for the treatment of patients with BRAFV600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is an 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.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, with desiccant, in outer carton - 7 tablets - 24 months from date of manufacture stored at 2° to 8°C. Refrigerate. protect from light and moisture - Bottle, plastic, HDPE, with desiccant, in outer carton - 30 tablets - 24 months from date of manufacture stored at 2° to 8°C. Refrigerate. protect from light and moisture

Authorization date:

2014-03-28

Patient Information leaflet

1
MEKINIST
®
_Trametinib (as dimethyl sulfoxide) 0.5 mg, and 2 mg tablets _
NZ 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.
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.MEDSAFE.GOVT.NZ.
Those 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, NURSE, OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MEKINIST IS
USED FOR?
MEKINIST tablet contain the active
ingredient trametinib. It 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 MEDICINES
TOGETHER, PLEASE READ THE
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 mutated gene and
slows down or stops the development
of

Summary of Product characteristics

NEW ZEALAND DATA SHEET
MEKINIST
 TABLETS
_trametinib dimethyl sulfoxide_
Page 1 of 45
1. PRODUCT NAME
Mekinist 0.5 mg film coated tablet
Mekinist 2 mg film coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Mekinist 0.5 mg film coated tablet
Each film coated tablet contains trametinib dimethyl sulfoxide
equivalent to trametinib 500
microgram.
Mekinist 2 mg fi
lm coated tablet
Each film coated tablet contains trametinib dimethyl sulfoxide
equivalent to trametinib 2 mg.
EXCIPIENTS
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
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; or
Yellow, ovaloid, biconvex, unscored, film-coated tablets with
(Novartis logo) on one side and
TT on the other side.
Mekinist 2 mg film coated tablet
Pink, round, biconvex, film-coated tablets with ‘GS’ debossed on
one face and ‘HMJ’ on the
opposing face; or
Pink, round, biconvex, unscored, film-coated tablets with
(Novartis logo) on one side and LL on
the other side _ _
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Unresectable or metastatic melanoma
MEKINIST
in combination with dabrafenib is
indicated for the treatment of
patients with
BRAFV600 mutation positive unresectable Stage III or metastatic (Stage
IV) melanoma.
MEKINIST as a monotherapy is indicated for the treatment of patients
with BRAFV600 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).
Adjuvant treatment of melanoma
MEKINIST in combination with Tafinlar is indicated for the adjuvant
treatment of patients with
Stage III melanoma with a BRAF V600 mutation, following complete
resection.
NEW ZEALAND DATA SHEET
MEKINIST
 TABLETS
_trametinib dimethyl