IBRANCE CAPSULE 75mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Palbociclib

可用日期:

PFIZER PRIVATE LIMITED

ATC代码:

L01XE33

药物剂型:

CAPSULE

组成:

Palbociclib 75.000mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Pfizer Manufacturing Deutschland GmbH

授权状态:

ACTIVE

授权日期:

2016-07-21

资料单张

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

产品特点

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