Zytiga

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Abiraterone acetate 500mg

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Abiraterone acetate 500 mg

Dosage:

500 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Abiraterone acetate 500mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Purple 85F90093 Sodium laurilsulfate

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

Therapeutic indications:

ZYTIGA is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (ADT) for the treatment of high-risk metastatic hormone naive prostate cancer (mHNPC) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) ZYTIGA is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mCPRC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCPRC) who have received prior chemotherapy containing a taxane.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVdC-PE-PVC/Alu - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2016-07-11

Patient Information leaflet

ZYTIGA
®
TABLETS (210805) ACMI
1
ZYTIGA
® TABLETS
_abiraterone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZYTIGA tablets. 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 being given ZYTIGA
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN ZYTIGA ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING ZYTIGA.
You may need to read it again.
WHAT ZYTIGA IS USED
FOR
ZYTIGA is used to treat prostate
cancer that has spread to other parts
of the body. It reduces the levels of
the sex hormone testosterone.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZYTIGA HAS
BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
ZYTIGA is not addictive.
BEFORE YOU TAKE
ZYTIGA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE ZYTIGA:
•
if you are allergic
(hypersensitive) to abiraterone, or
other ingredients of ZYTIGA.
See Product Description at the
end of this leaflet for a list of
ingredients.
DO NOT TAKE ZYTIGA:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
passed. If you take ZYTIGA after
the expiry date it may not work.
DO NOT TAKE ZYTIGA:
•
if you are pregnant or maybe
potentially pregnant
ZYTIGA is not for use in women and
children.
_BEFORE YOU START TO USE IT: _
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
PROBLEMS WITH YOUR LIVER
You should not take ZYTIGA if you
have moderate or severe liver
disease. Your doctor will decide
whether ZYTIGA can be used if you
have a mild liver problem.
ZYTIGA may affect your liver.
When you are taking ZYTIGA your
doctor will check your blood to look
for any effects of ZYTIGA on your
liver.
HIGH BLOOD PRESSURE AND HEART
PROBLEMS
ZYTIGA can make high blood
pressure or heart fa

Summary of Product characteristics

20.210319
1
ZYTIGA (221117) ADS
ZYTIGA
®
ABIRATERONE ACETATE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ZYTIGA 250 mg tablets
ZYTIGA 500 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYTIGA tablets contain either 250 mg or 500 mg of abiraterone acetate.
_Excipients with known effects: _
Sugars as lactose
Each 250 mg tablet contains 189 mg of lactose and 6.8 mg of sodium.
Each 500 mg film-coated tablet contains 253.2 mg of lactose and 13.5
mg of sodium.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
ZYTIGA 250 mg uncoated tablets are white to off-white, oval-shaped
tablets, debossed with
“AA250” on one side.
ZYTIGA 500 mg film-coated tablets are purple, oval-shaped, film-coated
tablets, debossed with
“AA” on one side and “500” on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZYTIGA is indicated in combination with prednisone or prednisolone and
androgen deprivation
therapy (ADT) for the treatment of high-risk metastatic hormone naïve
prostate cancer (mHNPC)
or newly diagnosed high-risk metastatic hormone sensitive prostate
cancer (mHSPC)
ZYTIGA is also indicated with prednisone or prednisolone for:
•
the treatment of patients with metastatic castration resistant
prostate cancer (mCRPC)
who are asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy
(ADT) in whom chemotherapy is not yet clinically indicated (see
CLINICAL TRIALS section).
•
the treatment of patients with metastatic advanced prostate cancer
(castration resistant
prostate cancer, mCRPC) who have received prior chemotherapy
containing a taxane.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of ZYTIGA is 1000 mg (either two 500 mg tablets
or four 250 mg
tablets) as a single daily dose that MUST NOT BE TAKEN WITH FOOD.
ZYTIGA tablets must be taken
as a single dose once daily on an empty stomach. ZYTIGA must be taken
at least two hours after
eating and food must not be eaten for at least one hour after taking
ZYTIGA. The tablets must be
swa