Lynparza 100 mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Olaparib

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

Olaparib

Unit dalam pakej:

8 Tablets; 56 Tablets; 112 Tablets

Dikeluarkan oleh:

AbbVie Ltd

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LYNPARZA
® FILM-COATED TABLETS
OLAPARIB (100MG & 150MG)
1
WHAT IS IN THIS LEAFLET
1.
What Lynparza is used for
2.
How Lynparza works
3.
Before you use Lynparza
4.
How to use Lynparza
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Lynparza
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT LYNPARZA IS USED FOR
Lynparza is used for the treatment
of:
•
A TYPE OF OVARIAN CANCER
(_BRCA_-MUTATED) THAT HAS
RESPONDED TO THE FIRST
TREATMENT WITH STANDARD
PLATINUM-BASED
CHEMOTHERAPY.
o
A test is used to find out
whether you have
_BRCA_
-
mutated ovarian cancer.
•
OVARIAN CANCER THAT HAS
COME BACK (RECURRED).
It can
be used after the cancer has
responded to previous
treatment with standard
platinum-based
chemotherapy.
•
ADVANCED OVARIAN CANCER,
FALLOPIAN TUBE CANCER OR
PRIMARY PERITONEAL CANCER
WITH A CERTAIN TYPE OF
ABNORMAL _BRCA_ GENE OR A
POSITIVE LABORATORY TUMOUR
TEST FOR GENOMIC INSTABILITY
CALLED HRD.
Lynparza is
used in combination with
another anti-cancer medicine,
bevacizumab, as maintenance
treatment after the cancer has
responded to your first
treatment with platinum-
based chemotherapy. Your
healthcare provider will
perform a test to make sure
that Lynparza is right for you.
•
A CERTAIN TYPE OF BREAST
CANCER (_BRCA_-MUTATED,
HER2-NEGATIVE) WHICH HAS
SPREAD BEYOND THE ORIGINAL
TUMOUR.
You should have
received chemotherapy
medicines either before or
after your cancer has spread.
o
A test is used to find out
whether you have
_BRCA_
-mutated breast
cancer.
•
A CERTAIN TYPE OF BREAST
CANCER (_BRCA_-MUTATED,
_HER2_-NEGATIVE) WHEN THE
CANCER HAS NOT SPREAD TO
OTHER PARTS OF THE BODY AND
TREATMENT IS GOING TO BE
GIVEN AFTER SURGERY
(TREATMENT AFTER SURGERY IS
CALLED ADJUVANT THERAPY).
You should have received
chemotherapy medicines
before or after surgery.
o
A test is used to
determine whether you
have
_BRCA_
-mutated
breast cancer.
•
METASTATIC PANCREATIC
CANCER WITH A CER

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Lynparza 100 mg film-coated tablets
Lynparza 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lynparza 100 mg film-coated tablets
Each film-coated tablet contains 100 mg olaparib.
Lynparza 150 mg film-coated tablets
Each film-coated tablet contains 150 mg olaparib.
Excipient with known effect:
This medicinal product contains 0.24 mg sodium per 100 mg tablet and
0.35 mg sodium per 150 mg
tablet, i.e. essentially “sodium-free”.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Lynparza 100 mg film-coated tablets
Yellow to dark yellow, oval, bi-convex tablet, debossed with
‘OP100’ on one side and plain on the other
side.
Lynparza 150 mg film-coated tablets
Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150’
on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ovarian cancer
Lynparza is indicated as monotherapy for the:
•
maintenance treatment of adult patients with advanced (FIGO stages III
and IV)
_BRCA1/2_
-mutated
(germline and/or somatic) high-grade epithelial ovarian, fallopian
tube or primary peritoneal cancer
who are in response (complete or partial) following completion of
first-line platinum-based
chemotherapy.
•
maintenance treatment of adult patients with platinum-sensitive
relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to
platinum-based chemotherapy.
Lynparza is indicated in combination with bevacizumab for the
maintenance treatment of adult patients
with advanced epithelial ovarian, fallopian tube or primary peritoneal
cancer who are in complete or
partial response to first-line platinum-based chemotherapy and whose
cancer is associated with
homologous recombination deficiency (HRD)-positive status defined by
either:
•
a deleterious or suspected deleterious
_BRCA_
mutation, and/or
•
genomic instability.
Breast cancer
2
Lynparza is indicated for