IBRANCE FILM COATED TABLET 75MG

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Palbociclib

Доступно од:

PFIZER PRIVATE LIMITED

АТЦ код:

L01XE33

Фармацеутски облик:

TABLET, FILM COATED

Састав:

Palbociclib 75 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Pfizer Manufacturing Deutschland GmbH

Статус ауторизације:

ACTIVE

Датум одобрења:

2021-09-15

Информативни летак

IBRANCE
® TAB
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 26
1. NAME OF THE MEDICINAL PRODUCT
IBRANCE
®
75 mg, 100 mg, and 125 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg or 100 mg or 125 mg of
palbociclib freebase.
Excipients: see Section 6.1 (List of excipients) for the full list of
excipients.
Palbociclib is a yellow to orange powder with a pKa of 7.4 (the
secondary piperazine
nitrogen) and 3.9 (the pyridine nitrogen).
The 75 mg tablet is presented as a round, light purple, film-coated
tablet with “Pfizer”
debossed on one tablet face and “PBC 75” debossed on the opposite
tablet face.
The 100 mg tablet is presented as an oval, green, film-coated tablet
with “Pfizer” debossed on
one tablet face and “PBC 100” debossed on the opposite tablet
face.
The 125 mg tablet is presented as an oval, light purple, film-coated
tablet with “Pfizer”
debossed on one tablet face and “PBC 125” debossed on the opposite
tablet face.
3. PHARMACEUTICAL FORM
Film-coated tablets 75 mg, 100 mg, and 125 mg
Page 2 of 26
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Ibrance is indicated for the treatment of patients with hormone
receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer in
combination with:
-
an aromatase inhibitor as initial endocrine-based therapy; or
-
fulvestrant in patients with disease progression following endocrine
therapy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Ibrance is a 125 mg tablet taken orally once
daily for
21 consecutive days followed by 7 days off treatment (Schedule 3/1) to
comprise a complete
cycle of 28 days.
When co-administered with palbociclib, the aromatase inhibitor should
be administered
according to the dose reported in the approved prescribing
information.
When co-administered with palbociclib, the

Карактеристике производа

1. NAME OF THE MEDICINAL PRODUCT
IBRANCE 75 mg, 100 mg, and 125 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg or 100 mg or 125 mg of
palbociclib freebase.
Excipients: see Section 6.1 (List of excipients) for the full list of
excipients.
Palbociclib is a yellow to orange powder with a pKa of 7.4 (the
secondary piperazine
nitrogen) and 3.9 (the pyridine nitrogen).
The 75 mg tablet is presented as a round, light purple, film-coated
tablet with “Pfizer”
debossed on one tablet face and “PBC 75” debossed on the opposite
tablet face.
The 100 mg tablet is presented as an oval, green, film-coated tablet
with “Pfizer” debossed on
one tablet face and “PBC 100” debossed on the opposite tablet
face.
The 125 mg tablet is presented as an oval, light purple, film-coated
tablet with “Pfizer”
debossed on one tablet face and “PBC 125” debossed on the opposite
tablet face.
3. PHARMACEUTICAL FORM
Film-coated tablets 75 mg, 100 mg, and 125 mg
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Ibrance is indicated for the treatment of patients with hormone
receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer in
combination with:
-
an aromatase inhibitor as initial endocrine-based therapy; or
-
fulvestrant in patients with disease progression following endocrine
therapy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Ibrance is a 125 mg tablet taken orally once
daily for
21 consecutive days followed by 7 days off treatment (Schedule 3/1) to
comprise a complete
cycle of 28 days.
When co-administered with palbociclib, the aromatase inhibitor should
be administered
according to the dose reported in the approved prescribing
information.
When co-administered with palbociclib, the recommended dose of
fulvestrant is 500 mg
administered intramuscularly on Days 1, 15, 29, and once monthly
thereafter. Please refer to
the full prescribing information of fulvestrant.
Ibrance table