POMARZA 2 (POMALIDOMIDE CAPSULES 2mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Pomalidomide

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

Pomalidomide

Unit dalam pakej:

3 x 7 Capsules

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
POMARZA 1 (POMALIDOMIDE CAPSULES 1MG)
POMARZA 2 (POMALIDOMIDE CAPSULES 2MG)
POMARZA 3 (POMALIDOMIDE CAPSULES 3MG)
POMARZA 4 (POMALIDOMIDE CAPSULES 4MG)
Pomalidomide (1mg, 2mg, 3mg, 4mg)
WHAT IS IN THIS LEAFLET
1.
What POMARZA
is used for
2.
How POMARZA
works
3.
Before you use POMARZA
4.
How to use POMARZA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of POMARZA
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT POMARZA
IS USED FOR
POMARZA
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’.
POMARZA
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).
POMARZA
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 POMARZA
WORKS
POMARZA
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
POMARZA
with
bortezomib and dexamethasone
When
POMARZA
is
u

Ciri produk

PRESCRIBING INFORMATION
1
1.
NAME OF THE MEDICINAL PRODUCT
POMARZA 1 (POMALIDOMIDE CAPSULES 1mg)
POMARZA 2 (POMALIDOMIDE CAPSULES 2mg)
POMARZA 3 (POMALIDOMIDE CAPSULES 3mg)
POMARZA 4 (POMALIDOMIDE CAPSULES 4mg)
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 capsules.
_POMARZA 1 (POMALIDOMIDE CAPSULES 1mg): _
Light yellow to yellow colored powder filled into
hard gelatin capsule shells with purple colored cap and dark pink
colored body imprinted
and
‘1mg’ on cap & ‘520’ on body with white ink
_POMARZA 2 (POMALIDOMIDE CAPSULES 2mg):_
Light yellow to yellow colored powder filled into
hard gelatin capsule shells with purple colored cap and pink opaque
colored body imprinted
and
‘2mg’ on cap & ‘519’ on body with white ink
_POMARZA 3 (POMALIDOMIDE CAPSULES 3mg):_
Light yellow to yellow colored powder filled into
hard gelatin capsule shells with purple colored cap and violet opaque
colored body imprinted
and
‘3mg’ on cap & ‘518’ on body with white ink
_POMARZA 4 (POMALIDOMIDE CAPSULES 4mg):_
Light yellow to yellow colored powder filled into
hard gelatin capsule shells with purple colored cap and purple opaque
colored body imprinted
and
‘4mg’ on cap & ‘517’ on body with white ink
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
POMARZA 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.
POMARZA 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 progre