INERLOTINIB FILM COATED TABLET 100MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Erlotinib Hydrochloride eqv Erlotinib

Available from:

INTEGA PTE LTD

ATC code:

L01EB02

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Erlotinib Hydrochloride eqv Erlotinib 100.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Remedica Ltd

Authorization status:

ACTIVE

Authorization date:

2021-05-20

Summary of Product characteristics

INERLOTINIB
TM
Erlotinib hydrochloride
ANTINEOPLASTIC AGENT.
ATC CODE L01XE03
1. PHARMACEUTICAL FORM
InErlotinib Film Coated Tablet 100mg, 150mg
InErlotinib Film Coated Tablet 100mg: White to yellowish, round
biconvex, film-coated
tablet, engraved with "100" on one side.
InErlotinib Film Coated Tablet 150mg: White to yellowish, round
biconvex, film-coated
tablet, engraved with "150" on one side.
Qualitative and Quantitative Composition
_Active ingredient: _erlotinib.
One film-coated tablet of each strength contains erlotinib
hydrochloride, corresponding to
100mg and 150mg of erlotinib.
For excipients, see section 4.2.
2. CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER:
InErlotinib is indicated for the first-line treatment of patients with
locally advanced or
metastatic non-small cell lung cancer with EGFR activating mutations.
InErlotinib 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.
InErlotinib 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:
InErlotinib 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
erlotinib as first-line or
maintenance therapy in patients with locally advanced or metastatic
NSCLC.
The recommended daily dose of erlotinib is 150 mg taken at least one
hour before or two
hours after the ingestion of food.
Pancreatic cancer:
The recommended daily dose of erlotinib is 100 mg taken