IBRELYN 125 (Palbociclib Capsules 125mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PALBOCICLIB

Boleh didapati daripada:

DUOPHARMA HAPI SDN. BHD.

INN (Nama Antarabangsa):

PALBOCICLIB

Unit dalam pakej:

30 Capsules; 21 Capsules; 7 Capsules

Dikeluarkan oleh:

Natco Pharma Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
IBRELYN
_ _
Palbociclib Capsules (75mg, 100mg and 125 mg)
1
WHAT IS IN THIS LEAFLET
1. What IBRELYN is used for
2. How IBRELYN works
3. Before you use IBRELYN
4. How to use IBRELYN
5. While you are using IBRELYN
6. Side Effects
7.Storage & Disposal of IBRELYN
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of Revision
12. Serial Number
WHAT IBRELYN IS USED FOR
IBRELYN is a prescription medicine
used to treat hormone receptor (HR)-
positive,
human
epidermal
growth
factor
receptor
2
(HER2)-negative
breast cancer that has spread to other
parts
of
the
body
(metastatic)
in
combination with:
•
an aromatase inhibitor as the first
hormonal-based
therapy
in
women who have gone through
menopause, or
•
fulvestrant
in
women
with
disease
progression
following
hormonal therapy
HOW IBRELYN WORKS
IBRELYN belongs to the group of
medicines
called
antineoplastics.
IBRELYN interferes with the growth
of cancer cells, which are eventually
destroyed.
BEFORE YOU USE IBRELYN
_- When you must not use it _
It is not known if IBRELYN is safe
and effective in children.
_Pregnancy and lactation _
Do
not
take
IBRELYN
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant.
IBRELYN
can
harm
your
unborn
baby.
Females
who
are
able
to
become
pregnant
and
who
take
IBRELYN should use effective birth
control during treatment and for at
least
3
weeks
after
stopping
IBRELYN.
Talk
to
your
healthcare
provider
about birth control methods that may
be right for you during this time.
If you become pregnant or think you
are
pregnant,
tell
your
healthcare
provider right away.
It is not known if IBRELYN passes
into your breast milk. Do not take
IBRELYN if you are breast-feeding
or plan to breastfeed.
_- Before you start to use it _
Tell your doctor if you:
•
have fever, chills, or any other
signs or symptoms of infection.
•
Experience
dizziness,
shortness
of
breath,
weakness,
or
any
increased
tendency
to
bleed
and/or to bruise.
•
have liver or kidney

Ciri produk

Page 1 of 7
[REVISION DATE: 08.11.2023]
[DUOPHARMA HAPI SDN BHD]
IBRELYN (PALBOCICLIB CAPSULES 75MG, 100MG AND 125MG)
DESCRIPTION:
IBRELYN 75: Yellow colored granular powder filled in size ‘2’ hard
gelatin capsule of light orange color cap imprinted with ‘NAT’ and
light
orange colour body imprinted with ‘75’.
IBRELYN 100: Yellow colored granular powder filled in size ‘1’
hard gelatin capsule of caramel color cap imprinted with ‘NAT’ and
light
orange colour body imprinted with ‘100’.
IBRELYN 125: Yellow colored granular powder filled in size ‘0’
hard gelatin capsule of caramel color cap imprinted with ‘NAT’ and
caramel
colour body imprinted with ‘125’.
COMPOSITION: _Capsule source: Bovine_
IBRELYN 75: Each hard gelatin capsule contains 75mg of Palbociclib.
IBRELYN 100: Each hard gelatin capsule contains 100mg of Palbociclib.
IBRELYN 125: Each hard gelatin capsule contains 125mg of Palbociclib.
PHARMACODYNAMICS:
PHARMACOTHERAPEUTIC GROUP: ANTINEOPLASTIC AGENTS, PROTEIN KINASE
INHIBITORS, ATC CODE: L01XE33.
MECHANISM OF ACTION
Palbociclib is a highly selective, reversible inhibitor of
cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are
downstream of
multiple signalling pathways which lead to cellular proliferation.
PHARMACODYNAMIC EFFECTS
Through inhibition of CDK4/6, palbociclib reduced cellular
proliferation by blocking progression of the cell from G1 into S phase
of the cell
cycle. Testing of palbociclib in a panel of molecularly profiled
breast cancer cell lines revealed high activity against luminal breast
cancers,
particularly ER-positive breast cancers. In the cell lines tested, the
loss of retinoblastoma (Rb) was associated with loss of palbociclib
activity.
However, in a follow-up study with fresh tumour samples, no relation
between RB1 expression and tumour response was observed. Similarly,
no relation was observed when studying the response to palbociclib in
_in vivo_
models with patient-derived xenografts (PDX models).
CARDIAC ELECTROPHYSIOLOGY
The effect