LYNPARZA olaparib 150 mg film coated tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

olaparib, Quantity: 150 mg

Հասանելի է:

AstraZeneca Pty Ltd

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: copovidone; colloidal anhydrous silica; mannitol; sodium stearylfumarate; hypromellose; macrogol 400; titanium dioxide; iron oxide yellow; iron oxide black

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

56 tablets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Ovarian cancer,LYNPARZA is indicated as monotherapy for the:,? maintenance treatment of adult patients who have advanced, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer with a deleterious or suspected deleterious, breast cancer susceptibility gene (BRCA) mutation (germline or somatic), which is in response (complete or partial) to first-line platinum-based chemotherapy.,? maintenance treatment of adult patients who have platinum-sensitive relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens.,LYNPARZA in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients who have advanced, epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) to first-line platinumbased 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 Breast cancer,LYNPARZA is indicated as monotherapy for the:,? treatment of adult patients with germline BRCA-mutated HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Germline BRCA mutation (gBRCAm) status should be determined by an experienced laboratory using a validated test method.,LYNPARZA is indicated as monotherapy for the:,? adjuvant treatment of adult patients with BRCA-mutated HER2-negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 -Dose and method of administration and 5.1 -Pharmacodynamic properties). Prostate cancer,LYNPARZA is indicated as monotherapy for the:,? treatment of adult patients who have metastatic castration-resistant prostate cancer (mCRPC) with a deleterious or suspected deleterious BRCA mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent.,LYNPARZA in combination with abiraterone and either prednisone or prednisolone is indicated for the:,? treatment of adult patients who have mCRPC with a deleterious or suspected deleterious BRCA mutation (germline or somatic). Adenocarcinoma of the pancreas,LYNPARZA is indicated as monotherapy for the:,? maintenance treatment of adult patients who have metastatic pancreatic adenocarcinoma with a deleterious or suspected deleterious gBRCAm, which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Ապրանքի ամփոփագիր:

Visual Identification: Green to green/grey film-coated, oval, biconvex tablet, debossed with 'OP 150' on one side and plain on the reverse; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2018-05-23

Տեղեկատվական թերթիկ

LYNPARZA
® TABLETS
_olaparib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LYNPARZA tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has 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 LYNPARZA
TABLETS ARE USED FOR
LYNPARZA tablets are used to treat
•
a certain 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 that has recurred
and it has responded to previous
treatment with platinum-based
chemotherapy.
•
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.
•
a certain 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 certain type of pancreatic cancer
(germline BRCA-mutated) which
has spread beyond the original
tumour. It is used if the cancer
has not progressed after treatment
with chemotherapy. A test is used
to determine whether you have
BRCA-mutated pancreatic
cancer.
•
a certain type of prostate cancer
(BRCA-mutated) which has
spread beyond the original
tumour and no longer responds to
medical or surgical treatment that
lowers testosterone. You should
have already rece

Ապրանքի հատկությունները

1 of 37
AUSTRALIAN PRODUCT INFORMATION
LYNPARZA
®
OLAPARIB TABLETS
1
NAME OF THE MEDICINE
Olaparib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LYNPARZA tablets consist of either 100 mg or 150 mg olaparib drug
substance and the following
inactive ingredients; copovidone, colloidal anhydrous silica,
mannitol, sodium stearylfumarate
hypromellose, macrogol 400, titanium dioxide and iron oxide yellow.
LYNPARZA 150 mg tablets
also contain iron oxide black.
3
PHARMACEUTICAL FORM
LYNPARZA 150 mg tablets are a green to green/grey, oval, bi-convex
tablet debossed with
‘OP150’ on one side and plain on the reverse.
LYNPARZA 100 mg tablets are a yellow to dark yellow, oval, bi-convex
tablet debossed with
‘OP100’ on one side and plain on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OVARIAN CANCER
LYNPARZA is indicated as monotherapy for the:
•
maintenance treatment of adult patients with advanced breast cancer
susceptibility gene
(
_BRCA_
) mutated (germline or somatic) 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.
_BRCA_
mutation status should be determined by an
experienced laboratory using a validated test method.
•
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 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