COTELLIC FILM COATED TABLET 20MG

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

Cobimetinib hemifumarate

Disponible desde:

ROCHE (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

Cobimetinib hemifumarate

Unidades en paquete:

3 X 21tablet Tablets

Fabricado por:

F.HOFFMANN - LA ROCHE LTD

Información para el usuario

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COTELLIC
®
FILM-COATED TABLET
_Cobimetinib (20mg) _
1
WHAT IS IN THIS LEAFLET
1.
What Cotellic is used for
2.
How Cotellic works
3.
Before you use Cotellic
4.
How to use Cotellic
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Cotellic
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT COTELLIC IS USED FOR
Cotellic is an anti-cancer medicine that
contains the active substance cobimetinib.
Cotellic is used to treat adult patients with
a type of skin cancer called melanoma that
has spread to other parts of the body or
cannot be removed by surgery.
Cotellic
is
used
in
combination
with
another
anti-cancer
medicine
called
vemurafenib.
This medicine can only be used in patients
whose cancer has a change (mutation) in a
protein called “BRAF”. Before starting
treatment, your doctor will test for this
mutation. This change may have led to the
development of melanoma.
HOW COTELLIC WORKS
Cotellic targets a protein called “MEK”
that is important in controlling cancer cell
growth. When Cotellic is used in
combination with vemurafenib (which
targets the changed “BRAF” protein), it
further slows down or stops the growth of
your cancer.
BEFORE YOU USE COTELLIC _ _
_- When you must not use it _
Do not take Cotellic if:
You
have
had
an
allergic
reaction
to
cobimetinib or any ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itching or hives on the skin.
If you are not sure, talk to your doctor,
pharmacist or nurse before taking Cotellic.
- _Before you start to use it _
Tell your doctor if:
1.
You are pregnant or plan to become
pregnant

Cotellic is not recommended during
pregnancy although the effects of
Cotellic have not been studied in
pregnant women, it may cause
permanent harm or birth def

Ficha técnica

PACK INSERT FOR MALAYSIA
Cotellic ® 20mg
Film -coated tablets
Cobimetin ib fumarate 

DESCRIPTION
Therapeutic / Pharmacologic Class of Drug
Cobimetinib is a small molecule that is a potent and highly selective targeted inhibitor of MEK1 and
MEK2 tyrosine -threonine kinases
ATC code: L01XE38
Type of Dosage Form
COTELLIC film -coated tablets 20mg are round, white, film -coated tablets with “COB ” embossed on one
side.
Route of administration
Oral
Sterile / Radioactive Statement
Not applicable
Qualitative and Quantitative Composition
Active ingredient: Cobimetinib
Each film -coated tablet contains 20 mg cobimetinib (22 mg as cobimetinib hemifumarate salt).
Excipients:
Core : m icrocrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.
Film coat : polyvinyl alcohol, titanium dioxide, macrogol/PEG 3350, talc.
PHARMACOLOGY
Mechanism of Action
The mitogen -activated protein kinase (MAPK)/extracellular signal regulated kinase (MEK) pathway is a
key signaling pathway that regulates cell proliferation, cell cycle regulation, cell survival, angiogenesis,
and cell migration.
Cobimetinib is an orally available inhibitor of MEK1 and MEK2 tyrosine -threonine ki nases. It has
shown high inhibitory potency in biochemical and cell based assays, as well as anti -tumour activity in
vivo in xenograft tumour models mutated for BRAF. Cobimetinib also showed efficacy in some KRAS
mutant models.
In biochemical and structur al studies, cobimetinib has been shown to interact with MEK in a manner that
is less susceptible to the dynamic conformational changes seen with the phosphorylation state of MEK.
As a result cobimetinib maintains binding affinity and inhibitory activity wh en MEK becomes
phosphorylated. Due to this distinct allosteric mechanism of inhibition, cobimetinib has shown strong
activity in cancer cell lines and tumours with high phosphorylated MEK levels, as is frequently observed
in BRAF mutant tumours.
In pre -clinical studies, treatment of MAPK -dysregulated cancer cells and tumou