Lynparza

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Olaparib 100mg;  

Tilgjengelig fra:

AstraZeneca Limited

Dosering :

100 mg

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Olaparib 100mg   Excipient: Colloidal silicon dioxide Copovidone Hypromellose Iron oxide yellow Macrogol 400 Mannitol Purified water Sodium stearyl fumarate Titanium dioxide

Resept typen:

Prescription

Indikasjoner:

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens. Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Lynparza in combination with bevacizumab is indicated 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 (germline or somatic), and/or - genomic instability HRD status should be determined by an experienced laboratory using a validated test method.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, Al/Al blister - 56 tablets - 48 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

2018-01-15

Informasjon til brukeren

Lynparza
®
Tablets CMI 170323
Copyright
1(7)
LYNPARZA
® TABLETS
OLAPARIB 100 AND 150 MG TABLETS.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about LYNPARZA. It
does not contain all the
information that is known about LYNPARZA TABLETS.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking
LYNPARZA TABLETS against the benefits they expect it will have for
you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ARE LYNPARZA TABLETS USED FOR
LYNPARZA tablets are used to treat
•
a type of ovarian cancer (BRCA-mutated) that is newly diagnosed. It is
used once the cancer
has responded to treatment with standard platinum-based chemotherapy.
A test is used to
determine whether you have BRCA-mutated ovarian cancer.
•
ovarian cancer in combination with another anti-cancer medicine called
bevacizumab. These
medicines are used together once the cancer has responded to the first
treatment with
standard platinum-based chemotherapy.
•
ovarian cancer that has recurred and it has responded to previous
treatment with platinum-
based chemotherapy.
•
a type of breast cancer (germline BRCA-mutated, human epidermal growth
factor receptor 2-
negative (HER2-negative)) which has spread beyond the original tumour.
You should have
received chemotherapy medicines either before or after your cancer has
spread. A test is
used to determine if you have germline BRCA mutated breast cancer.
•
a 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. A test is used to determine whether you have
BRCA-mutated breast
cancer.
•
a certain type of

Preparatomtale

L
YNPARZA
Tablets Data Sheet 190623
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
L
YNPARZA
®
150 mg film-coated Tablets
L
YNPARZA
®
100 mg film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 150 mg film-coated tablet contains 150 mg of olaparib.
Each 100 mg film-coated tablet contains 100 mg of olaparib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The L
YNPARZA
150 mg tablet is a green to green/grey, oval, bi-convex tablet, 14.5
mm x
7.25 mm, debossed with ‘OP150’ on one side and plain on the
reverse.
The L
YNPARZA
100 mg tablet is a yellow to dark yellow, oval, bi-convex tablet, 14.5
mm x
7.25 mm, debossed with ‘OP100’ on one side and plain on the
reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OVARIAN CANCER
L
YNPARZA
is indicated as monotherapy for the:

maintenance treatment of adult patients with newly diagnosed advanced
_ BRCA_-
mutated high-grade epithelial ovarian, fallopian tube or primary
peritoneal cancer who
are in response (complete response or partial response) to 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 response or partial response) after platinum-based
chemotherapy.
Prior
treatment must have included at least 2 courses of platinum-based
regimens.
L
YNPARZA
in combination with bevacizumab is indicated 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:
L
YNPARZA
Tablets Data Sheet 190623
Copyright
2

a deleterious or suspected deleterious _BRCA_ mutation (germline or
somatic),
and/or

genomic instability
HRD status should be determined by an experien