LYNPARZA olaparib 50 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olaparib, Quantity: 50 mg

Available from:

AstraZeneca Pty Ltd

INN (International Name):

olaparib

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: gellan gum; hypromellose; titanium dioxide; potassium acetate; lauroyl macrogolglycerides; iron oxide black; Shellac

Administration route:

Oral

Units in package:

4 x 112

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: White opaque hard capsules marked with "OLAPARIB 50 mg" and the AstraZeneca logo printed in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2016-01-07

Patient Information leaflet

LYNPARZA
® CAPSULES
_olaparib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LYNPARZA
capsules. 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
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
CAPSULES ARE 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. PARP inhibitors can
destroy cancer cells that are not good
at repairing DNA damage. These
specific cancer cells can be identified
by looking for faulty DNA repair
genes, such as BRCA (BReast
CAncer) genes. 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 TAKE
LYNPARZA CAPSULES
_WHEN YOU MUST NOT TAKE 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

Summary of Product characteristics

LYNPARZA Capsules Product Information
1
AUSTRALIAN PRODUCT INFORMATION
LYNPARZA
®
olaparib
capsules
1
NAME OF THE MEDICINE
Olaparib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LYNPARZA capsules consist of 50 mg olaparib drug substance suspended
in the semi-solid
lipidic excipient lauroyl macrogolglycerides, within a hypromellose
capsule shell which also
contains
gellan gum, titanium dioxide and potassium acetate
. The printing ink used contains
shellac and iron oxide black.
3
PHARMACEUTICAL FORM
LYNPARZA capsules are white and are marked with “OLAPARIB 50 mg”
and the
AstraZeneca logo printed in black ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LYNPARZA 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
D
OSE AND METHOD OF ADMINISTRATION
Treatment with LYNPARZA should be initiated and supervised by a
physician experienced
in the use of anticancer medicinal products.
IMPORTANT ADMINISTRATION INFORMATION
LYNPARZA is also available as a 100mg and 150 mg tablet. DO NOT
substitute
LYNPARZA capsules (50 mg) with LYNPARZA 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 full prescribing information for LYNPARZA
tablets for specific
tablet dosing.
Patients must have confirmation of a breast cancer susceptibility gene
(
_BRCA_
) mutation
(germline or tumour) before LYNPARZA treatment is initiated.
_BRCA_
mutation status
should be determined by an experienced laboratory using a validated
test method.
LYNPARZA Capsules Product Information
2
DOSAGE IN ADULTS
The recommended dose of LYNPARZA is 400 mg (eight 50 mg capsules)
taken twice daily,
equivalent to a total d