Erluntas Film Coated Tablet 150mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ERLOTINIB HYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ERLOTINIB HYDROCHLORIDE

Unit dalam pakej:

30 Tablets; 100 Tablets; 60 Tablets

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

ERLUNTAS FILM COATED TABLET
Erlotinib (100mg, 150mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET:
1.
What Erluntas is used for
2.
How Erluntas works
3.
Before you use Erluntas
4.
How to use Erluntas
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Erluntas
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ERLUNTAS IS USED FOR
Erluntas contains the active
ingredient erlotinib.
Erluntas is indicated for adults.
This medicine can be prescribed
to you if you have non-small cell
lung cancer at an advanced
stage. It can be prescribed as
initial therapy if your cancer
cells have specific EGFR
mutations. It can also be
prescribed if your disease
remains largely unchanged after
initial chemotherapy, or if
previous chemotherapy has not
helped to stop your disease.
Erluntas is also used in
combination with gemcitabine
for the treatment of pancreatic
cancer.
HOW ERLUNTAS WORKS
As a targeted cancer treatment,
Erluntas targets a specific
protein on the surface of the
cancer cells called EGFR/HER1
(epidermal growth factor
receptor 1). It slows or blocks
the activity of EGFR and may
cause the cancer cells to die,
with potentially less damage to
normal cells. However, the way
Erluntas works to treat cancer is
not fully known.
BEFORE YOU USE ERLUNTAS
-
_When you must not use it _
Do not take Erluntas if:
-
have had an allergic reaction
to Erluntas or any ingredients
listed at the end of this leaflet.
-
the package is torn or shows
signs of tampering.
-
the expiry date (EXP) printed
on the pack has passed.
If you take this medicine after
the expiry date has passed, it
may not work as well.
If you are not sure if you
should be taking Erluntas, talk
to your doctor.
_USE IN CHILDREN_
Do not give Erluntas to children.
Safety and effectiveness in
patients less than 18 years of
age have not been established.
-
_Before you start to use it _
Your doctor must know about
all the following before you start
to take Erluntas. Tel

Ciri produk

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PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Erluntas Film Coated Tablet 100mg
Erluntas Film Coated Tablet 150mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Erluntas Film Coated Tablet 100mg
Each film coated tablet contains 100mg of Erlotinib.
Each film coated tablet contains 109.27 mg Erlotinib Hydrochloride
equivalent to 100.00 mg Erlotinib
Erluntas Film Coated Tablet 150mg
Each film coated tablet contains 150mg of Erlotinib.
Each film coated tablet contains 163.90 mg Erlotinib Hydrochloride
equivalent to 150.00 mg Erlotinib
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet.
Erluntas Film Coated Tablet 100mg
White to yellowish, round biconvex, film coated tablets with ‘100’
engraved on one side of the tablet
Erluntas Film Coated Tablet 150mg
White to yellowish, round biconvex, film coated tablets with ‘150’
engraved on one side of the tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Erluntas is indicated for the first-line treatment of patients with
locally advanced or metastatic non-small cell lung cancer
(NSCLC) with EGFR activating mutations.
Erluntas is indicated for maintenance treatment in patients with
locally advanced or metastatic NSCLC with EGFR
activating mutations who have not progressed after firstline
chemotherapy.
Erluntas is also indicated for the treatment of patients with locally
advanced or metastatic NSCLC after failure of at least
one prior chemotherapy regimen
PANCREATIC CANCER
Erluntas in combination with gemcitabine is indicated for the
treatment of patients with locally advanced, unresectable
or metastatic pancreatic cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 STANDARD DOSAGE
NON-SMALL CELL LUNG CANCER
EGFR mutation testing should be performed prior to initiation of
Erluntas as first-line or maintenance therapy in patients
with locallyadvanced or metastatic NSCLC. The recommended daily dose
of Erluntas is 150 mg taken at least one hour
before or two hours after the ingestion