Lynparza

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Olaparib 50mg

Boleh didapati daripada:

AstraZeneca Limited

INN (Nama Antarabangsa):

Olaparib 50 mg

Dos:

50 mg

Borang farmaseutikal:

Capsule

Komposisi:

Active: Olaparib 50mg Excipient: Gellan gum Hypromellose Lauroyl macrogol-32 glycerides Iron oxide black Potassium acetate Shellac Titanium dioxide

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Lonza AG

Tanda-tanda terapeutik:

LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous 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.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP CRC, 4 bottles x 112 capsules - 448 capsules - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C

Tarikh kebenaran:

2016-06-08

Risalah maklumat

Lynparza
®
Capsules CMI 041120
Copyright
1(6)
LYNPARZA
® CAPSULES
OLAPARIB 50 MG CAPSULE.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
LYNPARZA. It does not contain
all the information that is known about LYNPARZA CAPSULES.
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
CAPSULES 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 IS USED FOR
You will have been prescribed LYNPARZA CAPSULES if you have ovarian
cancer and it has responded to
treatment with platinum-based chemotherapy and you have a mutation of
the BRCA gene. BRCA
stands for “BReast CAncer" gene. A genetic test will be done to
determine if you have the BRCA gene
mutation.
LYNPARZA is a PARP (Poly (ADP-Ribose) Polymerase enzymes) inhibitor.
It works by destroying cancer
cells when both copies of the BRCA gene, are faulty (mutated).
Carriers of a mutated BRCA gene have
a higher risk of developing certain cancers, including ovarian cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR
YOU. Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
BEFORE YOU USE LYNPARZA
_WHEN YOU MUST NOT USE IT _
Do not take LYNPARZA CAPSULES if you have an allergy to:

any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR INTEND TO BECOME
PREGNANT. It may affect your
developing baby if you take it during pregnancy.
DO NOT BREA

Ciri produk

L
YNPARZA
Data Sheet 240122
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
L
YNPARZA
®
50 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of olaparib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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
Olaparib
is
indicated as
monotherapy for
the
maintenance
treatment
of
patients
with
platinum-sensitive
relapsed
_BRCA-_mutated
(germline
or
somatic)
high
grade
serous
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with L
YNPARZA
should be initiated and supervised by a physician experienced in
the use of anticancer medicinal products.
IMPORTANT ADMINISTRATION INFORMATION
L
YNPARZA
is also available as a 100mg and 150 mg tablet. DO NOT substitute
L
YNPARZA
capsules (50 mg) with
L
YNPARZA
tablets (100 mg and 150 mg) on a milligram-to-milligram
basis due to differences in the dosing and bioavailability of each
formulation. Refer to
the Data Sheet for
L
YNPARZA
tablets for specific tablet dosing.
Patients must have confirmation of a breast cancer susceptibility gene
(_BRCA_) mutation
(germline or tumour) before L
YNPARZA
treatment is initiated.
_BRCA_ mutation status should
be determined by an experienced laboratory using a validated test
method.
DOSAGE IN ADULTS
The recommended dose of L
YNPARZA
is 400 mg (eight 50 mg capsules) taken twice daily,
equivalent to a total daily dose of 800 mg.
L
YNPARZA
Data Sheet 240122
Copyright
2
L
YNPARZA
should be taken on an empty stomach (at least 1 hour after a meal).
The capsules
should not be opened. Once L
YNPARZA
is taken, refrain from eating for 2 hours.
It is recommended that treatment be continued until progress