Pomalyst Capsules 1mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

pomalidomide

Boleh didapati daripada:

Celgene Sdn. Bhd.

INN (Nama Antarabangsa):

pomalidomide

Unit dalam pakej:

21capsule Capsules

Dikeluarkan oleh:

Celgene International Sarl

Risalah maklumat

POMALYST
®
CAPSULES
Pomalidomide (1mg, 2mg, 3mg, 4mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What POMALYST
®
is used for
2.
How POMALYST
®
works
3.
Before you use POMALYST
®
4.
How to use POMALYST
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
POMALYST
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT POMALYST
® IS USED FOR
POMALYST
®
is used to treat adults with
a
type
of
cancer
called
‘multiple
myeloma’.
Multiple myeloma is a type of cancer
which affects a certain type of white blood
cell (called the ‘plasma cell’). These cells
grow out of control and accumulate in the
bone marrow. This results in damage to
the bones and kidneys. Multiple myeloma
generally
cannot
be
cured.
However,
treatment
can
reduce
the
signs
and
symptoms of the disease or make them
disappear for a period of time. When this
happens, it is called ‘response’.
POMALYST
®
contains
the
active
substance ‘pomalidomide’. This medicine
is related to thalidomide and belongs to a
group
of
medicines
which
affect
the
immune
system
(the
body’s
natural
defences).
POMALYST
®
is either used with:
•
two
other
medicines
-
called
‘bortezomib’ (a type of chemotherapy
medicine)
and
‘dexamethasone’
(an
anti-inflammatory medicine) in people
who
have
had
at
least
one
other
treatment - including lenalidomide.
Or
•
one
other
medicine
-
called
‘dexamethasone’
in
people
whose
myeloma has become worse, despite
having at least two other treatments -
including
lenalidomide
and
bortezomib.
HOW POMALYST
®
_ _WORKS
POMALYST
®
works in several different
ways:
•
by
stopping
the
myeloma
cells
developing.
•
by stimulating the immune system to
attack the cancer cells.
•
by
stopping
the
formation
of
blood
vessels supplying the cancer cells.
The benefit of using POMALYST
®
with
bortezomib and dexamethasone
When
POMALYST
®
is
used
with
bortezomib and dexamethasone, in people
who have had at least one other treatment,
it

Ciri produk

1
1. NAME OF THE MEDICINAL PRODUCT
Pomalyst
®
1 mg hard capsules
Pomalyst
®
2 mg hard capsules
Pomalyst
®
3 mg hard capsules
Pomalyst
®
4 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 1 mg of pomalidomide.
Each hard capsule contains 2 mg of pomalidomide.
Each hard capsule contains 3 mg of pomalidomide.
Each hard capsule contains 4 mg of pomalidomide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
Pomalyst
®
1 mg hard capsule: Dark blue opaque cap and yellow opaque body,
imprinted “POML” in
white ink and “1 mg” in black ink, size 3, hard gelatin capsule.
Hard capsule.
Pomalyst
®
2 mg hard capsule: Dark blue opaque cap and orange opaque body,
imprinted “POML 2
mg” in white ink, size 1, hard gelatin capsule.
Hard capsule.
Pomalyst
®
3 mg hard capsule: Dark blue opaque cap and green opaque body,
imprinted “POML 3 mg”
in white ink, size 1, hard gelatin capsule.
Hard capsule.
Pomalyst
®
4 mg hard capsule: Dark blue opaque cap and blue opaque body,
imprinted “POML 4 mg”
in white ink, size 1, hard gelatin capsule.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pomalyst
®
in combination with bortezomib and dexamethasone is indicated in the
treatment of adult
patients with relapsed or refractory multiple myeloma who have
received at least one prior treatment
regimen including lenalidomide.
Pomalyst
®
in combination with dexamethasone is indicated in the treatment of
adult patients with
relapsed and refractory multiple myeloma who have received at least
two prior treatment regimens,
including both lenalidomide and bortezomib, and have demonstrated
disease progression on the last
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of
physicians experienced in the
management of multiple myeloma.
2
Dosing is continued or modified based upon clinical and laboratory
findings (see section 4.4).
Posology
•
_Pomalidomide in combination with bortezomib a