Tarceva Tablet 25 mg
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
16-10-2013
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Active ingredient:
Erlotinib hydrochloride eqv. to Erlotinib
Available from:
ROCHE SINGAPORE PTE. LTD.
ATC code:
L01XE03
Dosage:
25mg
Pharmaceutical form:
TABLET, FILM COATED
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
Kremers Urban Pharmaceuticals Inc.
Authorization date:
2006-02-10
Patient Information leaflet
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
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