Tarceva Tablet 100 mg

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Erlotinib hydrochloride eqv. Erlotinib

から入手可能:

ROCHE SINGAPORE PTE. LTD.

ATCコード:

L01EB02

投薬量:

100mg

医薬品形態:

TABLET, FILM COATED

構図:

Erlotinib hydrochloride eqv. Erlotinib 100mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

F. Hoffmann-La Roche Ltd (Kaiseraugst) (Primary and Secondary Packager)

認証ステータス:

ACTIVE

承認日:

2006-02-10

情報リーフレット

TARCEVA
TM 

Erlotinib hydrochloride   

ANTINEOPLASTIC AGENT. 
1. 
P
HARMACEUTICAL 
F
ORM

Tarceva film-coated tablets 25mg, 100mg, 150mg 
Tarceva tablet 25mg: Round, biconvex face and
straight sides, white film-coated, with ‘T 25’ 
engraved on one side. 
Tarceva tablet 100mg: Round, biconvex face and
straight sides, white film-coated,  with ‘T 
100’ engraved on one side. 
Tarceva tablet 150mg: Round, biconvex face and
straight sides, white film-coated,  with ‘T 
150’ engraved on one side. 

Qualitative and Quantitative Composition 
_Active ingredient:_ erlotinib. 
One film-coated tablet of each strength contains erlotinib
hydrochloride, corresponding to 
25mg, 100mg and 150mg of erlotinib. 
For excipients, see section 5.1. 
2. 
C
LINICAL 
P
ARTICULARS

2.1 
THERAPEUTIC INDICATIONS 
NON-SMALL CELL LUNG CANCER: 
Tarceva is indicated for the first-line
treatment of patients with locally advanced or 
metastatic non-small
cell lung cancer with EGFR activating mutations. 

Tarceva
is also indicated as monotherapy for maintenance treatment in patients with locally 
advanced or metastatic non-small
cell lung cancer with stable disease after 4 cycles of 
standard platinum-based first-line chemotherapy. 

Tarceva is also  indicated
for the treatment of patients with locally advanced
or metastatic 
non-small
cell lung cancer after failure of at least one prior chemotherapy regimen. 

No
survival benefit or other clinically relevant effects of the treatment have been 
demonstrated in    patients with Epidermal
Growth Factor Receptor (EGFR)-  negative 
tumours. 

PANCREATIC CANCER: 
Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients 
with locally advanced, unresectable or metastatic pancreatic cancer. 
2.2 
DOSAGE AND METHOD�

製品の特徴

1
PLEASE VISIT WWW.ROCHE.COM.SG/PHARMA/TARCEVA FOR A PRINTABLE VERSION
OF THIS LEAFLET.
TAB-TAR-2022 09-0
TARCEVA
TM
Erlotinib hydrochloride
ANTINEOPLASTIC AGENT.
ATC CODE L01EB02
1.
P
HARMACEUTICAL
F
ORM
Tarceva film-coated tablets 25mg, 100mg, 150mg
Tarceva tablet 25mg: Round, biconvex face and straight sides, white
film-coated, with ‘T 25’
engraved on one side.
Tarceva tablet 100mg: Round, biconvex face and straight sides, white
film-coated, with ‘T
100’ engraved on one side.
Tarceva tablet 150mg: Round, biconvex face and straight sides, white
film-coated, with ‘T
150’ engraved on one side.
Qualitative and Quantitative Composition
_Active ingredient:_
erlotinib.
One film-coated tablet of each strength contains erlotinib
hydrochloride, corresponding to
25mg, 100mg and 150mg of erlotinib.
For excipients, see section 4.2.
2.
C
LINICAL
P
ARTICULARS
2.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER:
Tarceva
is
indicated
for
the
first-line
treatment
of
patients
with
locally
advanced
or
metastatic non-small cell lung cancer with EGFR activating mutations.
Tarceva is also indicated for switch maintenance treatment in patients
with locally advanced
or metastatic NSCLC with EGFR activating mutations and stable disease
after first-line
chemotherapy.
Tarceva is also indicated for the treatment of patients with locally
advanced or metastatic
non-small cell lung cancer after failure of at least one prior
chemotherapy regimen.
No
survival
benefit
or
other
clinically
relevant
effects
of
the
treatment
have
been
demonstrated
in
patients
with
Epidermal
Growth
Factor
Receptor
(EGFR)-
negative
tumours.
PANCREATIC CANCER:
Tarceva in combination with gemcitabine is indicated for the
first-line treatment of patients
with locally advanced, unresectable or metastatic pancreatic cancer.
2.2
DOSAGE AND METHOD OF ADMINISTRATION
GENERAL
Non-small cell lung cancer:
EGFR mutation testing should be performed prior to initiation of
Tarceva as first-line or
maintenance therapy in patients with locally advanced or metastatic
NSC