Lynparza 50mg Hard Capsules

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

Olaparib

MAH:

ASTRAZENECA SDN. BHD.

INN:

Olaparib

units_in_package:

4 x 112capsule Capsules; 4x112capsule Capsules

manufactured_by:

Patheon Pharmaceuticals Inc.

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LYNPARZA 50MG HARD CAPSULES
OLAPARIB 50MG
1
WHAT IS IN THIS LEAFLET
1.
What Lynparza 50mg Hard
Capsules is used for
2.
How Lynparza 50mg Hard
Capsules works
3.
Before you use Lynparza
50mg Hard Capsules
4.
How to use Lynparza 50mg
Hard Capsules
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Lynparza 50mg Hard
Capsules
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LYNPARZA 50MG HARD
CAPSULES IS USED FOR
Lynparza 50mg Hard Capsules 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.
HOW LYNPARZA 50MG HARD
CAPSULES WORKS
Lynparza 50mg Hard Capsules
contain 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.
BEFORE YOU USE LYNPARZA 50MG
HARD CAPSULES_ _
_- When you must not use it _
Do not take Lynparza 50mg Hard
Capsules:
•
if you are allergic to olaparib
or any of the other ingredients
of this medicine.
•
if you are breast-feeding.
Do not take Lynparza 50mg Hard
Capsules if any of the above apply
to you. If you are not sure, talk to
your doctor, pharmacist or nurse
before taking Lynparza 50mg
Hard Capsules.
Do not take Lynparza 50mg Hard
Capsules if you are taking any
other anticancer medicines. Tell
your doctor, pharmacist, or nurse
if you are planning on receiving a
vaccine or a medicine that
suppresses the immune system, as
you may need to be closely
monitored.
_ _
_- Before you start to use it _
Talk to your doctor, pharmac

SPC

1
1. NA ME OF THE M ED ICINA L PRODUCT
Lynpar za 50 mg hard ca psules
2. QUAL ITAT IVE AN D QUANT ITAT IVE COMP OS ITION
Each h ard caps ule con tains 50 mg of ola parib. For t he f ull list of ex cipien ts, see section 6.1.
3. PHAR M ACEUT ICA L FORM
Hard c aps ule.
Wh ite, o paqu e, si ze 0 ha rd caps ule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in
black ink.
4. CL INICA L PART ICULARS
4.1 Therapeu tic ind ica tions
Lynpar za is ind ica ted as monoth erapy for the maint en ance treatment of ad ult patients with platinu m-
sensiti ve relapse d BRC A-mutate d (germlin e and/o r so matic) high grad e serou s epithelial ovarian,
fallo pian tube, or primary per iton eal can cer who are in respon se (comple te respon se or pa rtial
resp ons e) to platinu m-based che mothe rap y. Prior treatment must have included at least 2 courses of
platinum -based regimens.
4.2 Posology and met hod of admi nistra tion
Treatment with Lynpar za should be initiated and sup erv ised by a ph ysician exp erienced in the use of
an tica ncer med icinal prod ucts.
Pat ien ts must ha ve co nfirmation of a brea st canc er suscep tibility gene (BRCA ) mutation (either
germlin e or tumour ) befo re Lynpar za treatmen t is initiated . BRC A muta tion status shou ld be
det ermined by an ex perien ced labo ratory using a vali da ted test method (see section 5.1).
Th ere are limite d data in pa tients with so matic BRCA -mutated tumours (see sec tion 5.1).
Gene tic couns elling for patients with BRC A1/2 mutati ons shou ld be performed ac cording to loc al
regula tions.
Poso logy
The reco mmended dose of Lynpar za is 400 mg (ei ght caps ules) taken tw ice daily, equi valent to a
total da ily dose of 800 mg.
Pa tien ts sh ould start treatmen t wi th Lynpar za no later than 8 wee ks after complet ion of their final
dose of t he platinu m-conta ining regimen.
It is reco mm ended that treatment be continued un til progressi on of the und erlying dis ease or
unacceptable toxicity . The re are no da ta on retreatment with Lynpar za fol