Ibrance Capsules 100mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Palbociclib

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Palbociclib

Unit dalam pakej:

21capsule Capsules; 21capsule Capsules; 7 Capsules

Dikeluarkan oleh:

Pfizer Manufacturing Deutschland GmbH.

Risalah maklumat

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IBRANCE
® CAPSULES
Palbociclib (75 mg, 100 mg and 125 mg)
PLD Title
: Palbociclib (Ibrance)
PLD Date
: 02 July 2020
Country
: Malaysia
Reference Document
: 125 mg, 100 mg and 75 mg Palbociclib capsules of Malaysia CLD dated
18 June 2020
Reason for change
: PfLEET No: 2019-0047091 (S2): Alterations in dosing for severe
hepatic impairment
: PfLEET No: 2020-0060643 (S1): To update as per latest CLD
: To update as per BOH query
Pfizer Confidential
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IBRANCE
® CAPSULES
Palbociclib (75 mg, 100 mg and 125 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Ibrance is used for
2.
How Ibrance works
3.
Before you use Ibrance
4.
How to use Ibrance
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ibrance
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT IBRANCE IS USED FOR
Ibrance 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 IBRANCE WORKS
Ibrance belongs to the group of
medicines called antineoplastics.
Ibrance interferes with the growth of
cancer cells, which are eventually
destroyed.
BEFORE YOU USE IBRANCE
-
_When you must not use it _
It is not known if Ibrance is safe
and effective in children.
_Pregnancy and lactation _
Do not take Ibrance if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Ibrance can harm your unborn
baby. Females who are able to
become pregnant and who take
Ibrance should use effective birth
control during treatment and for
atleast 3 weeks after stopping
Ibrance.
The male partner of the female
patient (who are able to

Ciri produk

Pfizer Confidential
1
IBRANCE CAPSULES
PALBOCICLIB 75 MG, 100 MG AND 125 MG
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
IBRANCE 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.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSE AND SCHEDULE
The recommended dose of IBRANCE 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. IBRANCE should be
taken with food [
_see Clinical Pharmacology (11.3)_
].
Administer the recommended dose of an aromatase inhibitor when given
with IBRANCE. Please refer
to the full prescribing information for the aromatase inhibitor being
used.
When given with IBRANCE, 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 IBRANCE 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. IBRANCE capsules should be
swallowed whole (do not chew, crush
or open them prior to swallowing). Capsules should not be ingested if
they are broken, cracked, or
otherwise not intact.
Pre/perimenopausal women treated with the combination IBRANCE plus
fulvestrant therapy should also
be treated with luteinizing hormone releasing hormone (LHRH) agonists
according to current clinical
practice standards.
2.2
DOSE MODIFICATION
The recommended dose modifications for adverse reactions are listed in
Tables 1, 2 a