Lynparza
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
04-01-2024
Karatteristiċi tal-prodott
(SPC)
04-01-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
02-02-2023
Ingredjent attiv:
Olaparib
Disponibbli minn:
AstraZeneca AB
Kodiċi ATC:
L01XK01
INN (Isem Internazzjonali):
olaparib
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Ovarian Neoplasms
Indikazzjonijiet terapewtiċi:
Ovarian cancerLynparza 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 in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (FIGO stages III and IV) 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).Breast cancerLynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.Adenocarcinoma of the pancreasLynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.Prostate cancerLynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).
Sommarju tal-prodott:
Revision: 23
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2014-12-16
Fuljett ta 'informazzjoni
76
B. PACKAGE LEAFLET
77
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LYNPARZA 100 MG FILM-COATED TABLETS
LYNPARZA 150 MG FILM-COATED TABLETS
olaparib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lynparza is and what it is used for
2.
What you need to know before you take Lynparza
3.
How to take Lynparza
4.
Possible side effects
5.
How to store Lynparza
6.
Contents of the pack and other information
1.
WHAT LYNPARZA IS AND WHAT IT IS USED FOR
WHAT LYNPARZA IS AND HOW IT WORKS
Lynparza contains the active substance olaparib. Olaparib is a type of
cancer medicine called a PARP
inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).
PARP inhibitors can destroy cancer cells that are not good at
repairing DNA damage. These specific
cancer cells can be identified by:
response to platinum chemotherapy, or
looking for faulty DNA repair genes, such as _BRCA_ (BReast CAncer)
genes.
When Lynparza is used in combination with abiraterone (an androgen
receptor signalling inhibitor),
the combination may help enhance anti-cancer effect in prostate cancer
cells with or without faulty
DNA repair genes (e.g., _BRCA_ genes).
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
canc
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
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 in combination with bevacizumab is indicated for the:
maintenance treatment of adult patients with advanced (FIGO stages III
and IV) 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 in combination
with bevacizumab and whose cancer is associated with homologous
recombination deficiency
3
(HRD) positive status defined by either a _BRCA1/2_ mutation and/or
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