LYNPARZA 50 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

OLAPARIB

Commercializzato da:

ASTRA ZENECA (ISRAEL) LTD

Codice ATC:

L01XX46

Forma farmaceutica:

HARD CAPSULE

Composizione:

OLAPARIB 50 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

ASTRA ZENECA UK LIMITED

Area terapeutica:

OLAPARIB

Indicazioni terapeutiche:

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 cancer, (including fallopian tube, or primary peritoneal) cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Data dell'autorizzazione:

2015-09-10

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
LYNPARZA 50 MG
CAPSULES
COMPOSITION:
Each capsule contains: Olaparib 50 mg
For inactive ingredients, please see section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet. You may need it again.
This leaflet contains concise information about the medicine. If you
have any further
questions, ask your doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It
may harm them, even if it seems to you that their ailment is similar.
1. WHAT LYNPARZA IS AND WHAT IT IS USED FOR?
Lynparza is used to treat ovarian cancer in patients carrying the
BRCA
mutation whom
have responded to previous platinum based chemotherapy. A test is used
to determine
whether the cancer you are suffering from has the
BRCA
mutation.
In patients with mutations (changes) in certain genes (genetic
factors) 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.
THERAPEUTIC GROUP
PARP (poly adenosine diphosphate-ribose polymerase) inhibitor.
A doctor who is experienced in the use of anticancer medicinal
products may prescribe
Lynparza.
2. BEFORE USING THE MEDICINE:
X DO NOT USE THE MEDICINE IF:
! SPECIAL WARNINGS REGARDING USE OF LYNPARZA:
BEFORE AND DURING THE COURSE OF TREATMENT WITH LYNPARZA, CONSULT THE
DOCTOR,
PHARMACIST OR NURSE:
• If you have low blood-cell counts on testing. These may be low red
blood-cell count
(anaemia), low white blood-cell count (neutropaenia), or low
blood-platelet count
(thrombocytopenia).
For further information, see section 4 – “Side Effects”. Look
out for signs and symptoms
such as: fever or infection, bruising or bleeding. Rarely, these may
be a sign of a more
serious problem with the bone marrow s

Scheda tecnica

THIS LEAFLET FORMAT WAS DETERMINED BY THE MINISTRY OF HEALTH
AND THE CONTENT THEREOF WAS CHECKED AND APPROVED IN 10.2018 AND WAS
UPDATED ACCORDING
TO MINISTRY OF HEALTH GUIDELINES IN FEB 2019
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 that treatment be continued until progression of the
underlying disease. There
are no data on retreatment with Lynparza following subsequent relapse
(see section 5.1).
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