Tagrisso Film-Coated Tablet 80mg

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

Osimertinib

Commercializzato da:

ASTRAZENECA SDN. BHD.

INN (Nome Internazionale):

Osimertinib

Confezione:

30 Tablets

Prodotto da:

ASTRAZENECA AB

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TAGRISSO
® FILM-COATED TABLETS
OSIMERTINIB (40MG & 80MG)
1
WHAT IS IN THIS LEAFLET
1.
What TAGRISSO is used for
2.
How TAGRISSO works
3.
Before you use TAGRISSO
4.
How to use TAGRISSO
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
TAGRISSO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT TAGRISSO IS USED FOR
TAGRISSO contains the active
substance osimertinib which
belongs to a group of medicines
called protein kinase inhibitors.
TAGRISSO is used to treat adults
with a type of lung cancer called
‘non-small cell lung’ when the
tumour has a defect (mutation) in
gene called EGFR (epidermal
growth factor receptor).
TAGRISSO can be prescribed for
you:
•
If you test positive for an
‘exon 19 deletion’ or an ‘exon
21 (
_L858R_
) substitution
mutation’
- to help prevent your lung
cancer from coming back after
your tumour(s) has been
completely removed by
surgery.
•
If you test positive for an
‘exon 19 deletion’ or an ‘exon
21 (
_L858R_
) substitution
mutation’
- as your first treatment when
your lung cancer has
progressed locally or spread to
other parts of the body
•
If you test positive for a
‘
_T790M_
mutation’
- when your lung cancer has
progressed locally or spread to
other parts of the body and you
have had previous treatment
with an EGFR tyrosine kinase
inhibitor (TKI) medicine that
did not work or is no longer
working.
HOW TAGRISSO WORKS
TAGRISSO works by blocking
EGFR and may help to slow or
stop your lung cancer from
growing. It may also help to
shrink the tumour and prevent the
tumour from coming back after
removal by surgery
TAGRISSO will only be
prescribed to you by a doctor with
experience in the use of medicines
for cancer.
If you have any questions about
how this medicine works or why
this medicine has been prescribed
for you, ask your doctor.
BEFORE YOU USE TAGRISSO_ _
_When you must not use it _
Do not take TAGRISSO if:
•
you are allergic

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
TAGRISSO 40 mg film-coated tablets
TAGRISSO 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAGRISSO 40 mg tablets: Each tablet contains 40 mg osimertinib (as
mesylate).
TAGRISSO 80 mg tablets: Each tablet contains 80 mg osimertinib (as
mesylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
TAGRISSO 40 mg tablets: Beige, 9 mm, round, biconvex tablet, debossed
with “AZ” and “40”
on one side and plain on the reverse.
TAGRISSO 80 mg tablets: Beige, 7.25 x 14.5 mm, oval, biconvex tablet,
debossed with “AZ”
and “80” on one side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TAGRISSO (osimertinib) is indicated for:
•
the adjuvant therapy after tumour resection in adult patients with
non-small cell lung
cancer (NSCLC) whose tumours have epidermal growth factor receptor
(EGFR) exon
19 deletions or exon 21 (L858R) substitution mutations.
•
the first-line treatment of adult patients with locally advanced or
metastatic non-small
cell lung cancer (NSCLC) whose tumours have epidermal growth factor
receptor
(EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
•
the treatment of adult patients with locally advanced or metastatic
EGFR T790M
mutation-positive NSCLC whose disease has progressed on or after EGFR
TKI
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with TAGRISSO should be initiated by a physician experienced
in the use of
anticancer therapies.
When considering the use of TAGRISSO, EGFR mutation status should be
determined using
a validated test method (see section 4.4) for:
•
exon 19 deletions or exon 21 (L858R) substitution mutations (in tumour
specimens for
adjuvant treatment and tumour or plasma specimens for first-line
treatment)
•
T790M mutations (in tumour or plasma specimens following progression
on or after
EGFR TKI therapy).
Posology
The recommended dose is 80 mg osimertinib once a day.
Treat patients in the adjuv