Lynparza 50mg capsules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Olaparib

から入手可能:

AstraZeneca UK Ltd

ATCコード:

L01XX46

INN（国際名）:

Olaparib

投薬量:

50mg

医薬品形態:

Capsule

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 08010500; GTIN: 5000456007887

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LYNPARZA 50 MG HARD CAPSULES
olaparib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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).
In patients with mutations (changes) in certain genes called
_BRCA_
(breast cancer gene), who are at risk
of developing some forms of cancer, PARP inhibitors are able to
trigger the death of cancer cells by
blocking an enzyme that helps repair DNA.
WHAT LYNPARZA IS USED FOR
Lynparza is used for the treatment of a type of ovarian cancer called
“
_BRCA_
-mutated ovarian cancer”.
It is used after the cancer has responded to previous treatment with
standard platinum-based
chemotherapy. A test is used to determine whether you have
_BRCA_
-mutated cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYNPARZA
_ _
DO NOT TAKE
LYNPARZA:
•
if you are allergic to olaparib or any

製品の特徴

OBJECT 1
LYNPARZA 50 MG HARD CAPSULES
Summary of Product Characteristics Updated 11-May-2018 | AstraZeneca
UK Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Lynparza 50 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 50 mg of olaparib.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg”
and the AstraZeneca logo in black
ink.
4. Clinical particulars
4.1 Therapeutic indications
Lynparza is indicated as monotherapy for the maintenance treatment of
adult patients with platinum-
sensitive relapsed _BRCA_-mutated (germline and/or somatic) high grade
serous epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in response
(complete response or partial response)
to platinum-based chemotherapy.
4.2 Posology and method of administration
Treatment with Lynparza should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Patients must have confirmation of a breast cancer susceptibility gene
(_BRCA_) mutation (either germline
or tumour) before Lynparza treatment is initiated. _BRCA_ mutation
status should be determined by an
experienced laboratory using a validated test method (see section
5.1).
There are limited data in patients with somatic _BRCA_-mutated tumours
(see section 5.1).
Genetic counselling for patients with _BRCA_ mutations should be
performed according to local
regulations.
Posology
The recommended dose of Lynparza is 400 mg (eight capsules) taken
twice daily, equivalent to a total
daily dose of 800 mg.
Patients should start treatment with Lynparza no later than 8 weeks
after completion of their final dose of
the platinum-containing regimen.
It is recommended t