ZYTIGA abiraterone acetate 500 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

abiraterone acetate, Quantity: 500 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Abiraterone acetate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZYTIGA is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or ? patients with mCRPC who have received prior chemotherapy containing a taxane.

Product summary:

Visual Identification: Purple oval shaped film-coated tablet debossed with AA on one side and 500 on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-02-17

Patient Information leaflet

ZYTIGA® (210818) CMI
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.
•
if you have severe liver failure
ZYTIGA should not be used in
patients with severe liver failure. Ask
your doctor if you have questions.
•
if you are being treated with
XOFIGO
ZYTIGA and XOFIGO, a radiation
therapy, should not be used together.
_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

Summary of Product characteristics

(CCDS210319)
1
ZYTIGA (210818) API
AUSTRALIAN PRODUCT INFORMATION
ZYTIGA
® (
ABIRATERONE ACETATE)
TABLETS
1. NAME OF THE MEDICINE
Abiraterone acetate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYTIGA tablets contain either 250 mg or 500 mg of the active
ingredient abiraterone acetate.
Excipient(s) with known effect:
Contains sugars as lactose.
The 250 mg and 500 mg tablets contain 198.65 mg and 253.2 mg of
lactose monohydrate
respectively.
For a full list of excipients, see section 6.1 List of Excipients.
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 for
the treatment of:
•
newly diagnosed high-risk metastatic hormone sensitive prostate cancer
(mHSPC) in
combination with androgen deprivation therapy (ADT), or
•
patients with metastatic advanced prostate cancer (castration
resistant prostate cancer,
mCRPC) who are asymptomatic or mildly symptomatic after failure of
androgen deprivation
therapy (ADT) or
•
patients with mCRPC who have received prior chemotherapy containing a
taxane.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of ZYTIGA is 1 g (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 swallowed whole
with water (see section 5.2 Pharmacokinetic Properties –
Absorption).
Product Information - Australia
(CCDS210319)
2
ZYTIGA (210818) API
DOSAGE OF PREDNISONE OR PREDNISOLONE
For hormone sensitive prostate cancer (mHSPC), ZYTIGA is used with 5
mg prednisone or
predni