Alecensa (Alectinib) Hard Capsules 150mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Alectinib Hydrochloride

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Alectinib Hydrochloride

Unit dalam pakej:

224 Capsules

Dikeluarkan oleh:

Excella GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ALECENSA
®
HARD CAPSULES
_ _
Alectinib (150 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Alecensa is used for
2.
How Alecensa works
3.
Before you use Alecensa
4.
How to use Alecensa
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Alecensa
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ALECENSA IS USED FOR
Alecensa is used to treat adults with a
type of lung cancer called ‘non-small
cell lung cancer’ (‘NSCLC’). It is
used if your lung cancer:

is ‘ALK-positive’ - this means your
cancer cells have a fault in a gene
that makes an enzyme called ALK
(‘anaplastic
lymphoma
kinase’),
see ‘How Alecensa works’, below

and is advanced.
Alecensa can be prescribed to you as
first treatment of your lung cancer, or
if you have been previously treated
with
a
medicine
containing
‘crizotinib’.
HOW ALECENSA WORKS
Alecensa
blocks
the
action
of
an
enzyme called ‘ALK tyrosine kinase’.
Abnormal forms of this enzyme (due
to fault in the gene that makes it) help
encourage
cancer
cell
growth.
Alecensa may slow down or stop the
growth of your cancer. It may also
help to shrink your cancer.
If you have any questions about how
Alecensa works or why this medicine
has been prescribed for you, ask your
doctor, pharmacist or nurse.
BEFORE YOU USE ALECENSA
-
_When you must not use it _
If you are allergic to alectinib or any
of
the
other
ingredients
of
this
medicine
(listed
in
Product
Description).
If you are not sure, talk to your doctor,
pharmacist
or
nurse
before
taking
Alecensa.
-
_Before you start to use it _
Talk to your doctor, pharmacist or
nurse before taking Alecensa:

if you have an inherited problem
called
‘galactose
intolerance’,
‘congenital lactase deficiency’ or
‘glucose-galactose malabsorption’.
Alecensa contains lactose (a type of
sugar). If you have been told by your
doctor
that
you
cannot
tolerate
or
digest
some
sugars,
talk
to
your
doctor befor

Ciri produk

PACK INSERT FOR MALAYSIA
ALECENSA
®
150MG
Hard Capsules
Alectinib

1.
DESCRIPTION
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, Protein Kinase inhibitor
ATC code: L01ED03
1.2 TYPE OF DOSAGE FORM
White to yellowish white hard capsule of 19.2 mm, with “ALE”
printed in black ink on the cap and “150 mg” printed in
black ink on the body.
1.3 ROUTE OF ADMINISTRATION
Oral
1.4 STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Alectinib
Each hard capsule contains: Alectinib 150 mg (equivalent to 161.3 mg
alectinib hydrochloride).
_Capsule fill mass_
: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate,
carboxymethylcellulose calcium,
magnesium stearate, purified water.
_Capsule shell_
: carrageenan, potassium chloride, titanium dioxide (E171), carnauba
wax, corn starch, hypromellose, printing
ink (red iron oxide E172, yellow iron oxide E172, FD&C blue No. 2
aluminum lake E132, carnauba wax, white shellac,
glyceryl monooleate, 1-butanol, dehydrated ethyl alcohol).
2.
CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATIONS
Alecensa as monotherapy is indicated for the first-line treatment of
adult patients with anaplastic lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC).
Alecensa as monotherapy is indicated for the treatment of adult
patients with ALK-positive advanced NSCLC previously
treated with crizotinib.
2.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Alecensa should be initiated and supervised by a
physician experienced in the use of anticancer medicinal
products.
A validated ALK assay is necessary for the selection of ALK-positive
NSCLC patients. ALK-positive NSCLC status should
be established prior to initiation of Alecensa therapy.
Posology
The recommended dose of Alecensa is 600 mg (four 150 mg capsules)
taken twice daily with food (total daily dose of 1200
mg).
Patients with underlying severe hepatic impairment (Child-Pugh C)
should receive a starting dose of 450 mg taken twi