PALVORED 100 (PALBOCICLIB CAPSULES 100MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PALBOCICLIB

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

PALBOCICLIB

Unit dalam pakej:

21 Capsules; 7 Capsules

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PALVORED
CAPSULES
Palbociclib (75 mg, 100 mg and 125 mg)
2
WHAT IS IN THIS LEAFLET
1.
What Palvored is used for
2.
How Palvored works
3.
Before you use Palvored
4.
How to use Palvored
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Palvored
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT PALVORED IS USED FOR
PALVORED 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 PALVORED WORKS
Palvored belongs to the group of
medicines called antineoplastics.
Palvored interferes with the growth
of cancer cells, which are eventually
destroyed.
BEFORE YOU USE PALVORED
-
_When you must not use it _
_ _
It is not known if Palvored is safe
and effective in children.
_Pregnancy and lactation _
Do not take Palvored if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Palvored can harm your unborn
baby. Females who are able to
become pregnant and who take
Palvored should use effective birth
control during treatment, and for
atleast 2 weeks after stopping
Palvored.
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 Palvored passes
into your breast milk. Do not take
Palvored 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.
•
have dizziness, shortness of
breath, weakness or any
increased tendency to bleed
and/or to bruise.
•
have li

Ciri produk

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PRESCRIBING INFORMATION
PALVORED
(PALBOCICLIB CAPSULES 75MG/100MG/125 MG)
COMPOSITION
Each Capsule contains:
Palbociclib 75 mg, 100 mg, 125 mg
Source of Capsules: Bovine
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
PALVORED is indicated for the treatment of hormone receptor
(HR)-positive, human epidermal
growth factor receptor 2 (HER2)-negative locally advanced or
metastatic breast cancer in
combination with:
-
an aromatase inhibitor as initial endocrine based therapy in
postmenopausal women, or;
-
fulvestrant in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be
combined with a luteinizing
hormone-releasing hormone (LHRH) agonist.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of PALVORED is a 125 mg capsule taken orally once
daily for 21
consecutive days followed by 7 days off treatment to comprise a
complete cycle of 28 days.
PALVORED should be taken with food
_ _
_ _
Administer the recommended dose of an aromatase inhibitor when given
with PALVORED.
Please refer to the full prescribing information for the aromatase
inhibitor being used.
When co-administered with PALVORED, the recommended dose of
fulvestrant is 500 mg
administered on Days 1, 15, 29, and once monthly thereafter. Please
refer to the full prescribing
information of fulvestrant.
Patients should be encouraged to take their dose of PALVORED at
approximately the same time
each day.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next prescribed
dose should be taken at the usual time. PALVORED capsules should be
swallowed whole (do not
chew, crush or open them prior to swallowing). Capsules should not be
ingested if it is broken,
cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination PALVORED plus
fulvestrant therapy
should be treated with luteinizing hormone releasing hormone (LHRH)
agonists according to
current clinical practice standards.
DOSE MODIFICATION
The recommende