COTELLIC FILM-COATED TABLET 20 MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Cobimetinib Hemifumarate 22.20mg eqv to Cobimetinib

Boleh didapati daripada:

ROCHE SINGAPORE PTE. LTD.

Kod ATC:

LO1XE

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

Cobimetinib Hemifumarate 22.20mg eqv to Cobimetinib 20mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

F. Hoffmann-La Roche Ltd

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2017-04-21

Ciri produk

1
PLEASE VISIT WWW.ROCHE.COM.SG/PHARMA/COTELLIC FOR A PRINTABLE VERSION
OF
THIS LEAFLET
TAB-COT-2023 08
______________________________________________________________
COTELLIC FILM-COATED TABLET 20MG
Cobimetinib
______________________________________________________________
1.
DESCRIPTION
1.1
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
1.2
TYPE OF DOSAGE FORM
Film-coated tablet
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Cobimetinib
Each
film-coated tablet
contains
20
mg
cobimetinib
(22.20
mg
as
cobimetinib
hemifumarate salt). Cobimetinib tablets 20 mg, are round, white,
film-coated tablets with
“COB” debossed on one side.
Excipients:
Core:
Lactose
monohydrate,
microcrystalline
cellulose,
croscarmellose
sodium,
magnesium stearate
Film coat: polyvinyl alcohol, titanium dioxide, polyethylene glycol
3350, talc
2
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Cotellic is indicated for use in combination with vemurafenib for the
treatment of patients
with unresectable or metastatic melanoma with BRAF V600 mutation.
2.2
DOSAGE AND ADMINISTRATION
_GENERAL _
Cotellic therapy should only be initiated and supervised by a
healthcare professional
experienced in the treatment of patients with cancer.
Patients treated with Cotellic in combination with vemurafenib must
have BRAF V600
mutation-positive melanoma tumor status confirmed by a validated test.
Please also refer to the full prescribing information for vemurafenib,
which is used in
combination with Cotellic.
_Standard Dosage _
The recommended dose of Cotellic is 60 mg (three 20 mg tablets) once
daily.
Cotellic is taken on a 28 day cycle. Each Cotellic dose consists of
three 20 mg tablets
(60mg) and should be taken once daily for 21 consecutive days (days 1
to 21 - treatment
period); followed by a 7 day break in