IBRANCE CAPSULE 125mg

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Palbociclib

Доступно од:

PFIZER PRIVATE LIMITED

АТЦ код:

L01XE33

Фармацеутски облик:

CAPSULE

Састав:

Palbociclib 125.000mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Pfizer Manufacturing Deutschland GmbH

Статус ауторизације:

ACTIVE

Датум одобрења:

2016-07-21

Информативни летак

IBRANCE
® CAP
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 25
1. NAME OF THE MEDICINAL PRODUCT
IBRANCE
®
75 mg, 100 mg, and 125 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule 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 palbociclib drug product is provided as hard gelatin, opaque
capsules dosage strengths
of: 75 mg (Size #2, light orange body/light orange cap) in which the
body is printed with
“PBC 75” and the cap printed with “Pfizer” in white; 100 mg
(Size #1, light orange
body/caramel cap) in which the body is printed with “PBC 100” and
the cap printed with
“Pfizer” in white; and 125 mg (Size # 0, caramel body/caramel cap)
in which the body is
printed with “PBC 125” and the cap printed with “Pfizer” in
white.
3. PHARMACEUTICAL FORM
Hard gelatin capsules 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:
Page 2 of 25
-
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 capsule 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 recommen

Карактеристике производа

1. NAME OF THE MEDICINAL PRODUCT
IBRANCE
®
75 mg, 100 mg, and 125 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule 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 palbociclib drug product is provided as hard gelatin, opaque
capsules dosage strengths
of: 75 mg (Size #2, light orange body/light orange cap) in which the
body is printed with
“PBC 75” and the cap printed with “Pfizer” in white; 100 mg
(Size #1, light orange
body/caramel cap) in which the body is printed with “PBC 100” and
the cap printed with
“Pfizer” in white; and 125 mg (Size # 0, caramel body/caramel cap)
in which the body is
printed with “PBC 125” and the cap printed with “Pfizer” in
white.
3. PHARMACEUTICAL FORM
Hard gelatin capsules 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 capsule 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 should be t