Zytiga

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

abiraterone acetate

Available from:

Janssen-Cilag International N.V.

ATC code:

L02BX03

INN (International Name):

abiraterone

Therapeutic group:

Endocrine therapy

Therapeutic area:

Prostatic Neoplasms

Therapeutic indications:

Zytiga is indicated with prednisone or prednisolone for:the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2011-09-05

Patient Information leaflet

63
B. PACKAGE LEAFLET
64
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYTIGA 250 MG TABLETS
abiraterone acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ZYTIGA is and what it is used for
2.
What you need to know before you take ZYTIGA
3.
How to take ZYTIGA
4.
Possible side effects
5.
How to store ZYTIGA
6.
Contents of the pack and other information
1.
WHAT ZYTIGA IS AND WHAT IT IS USED FOR
ZYTIGA contains a medicine called abiraterone acetate. It is used to
treat prostate cancer in adult men
that has spread to other parts of the body. ZYTIGA stops your body
from making testosterone; this can
slow the growth of prostate cancer.
When ZYTIGA is prescribed for the early stage of disease where it is
still responding to hormone
therapy, it is used with a treatment that lowers testosterone
(androgen deprivation therapy).
When you take this medicine your doctor will also prescribe another
medicine called prednisone or
prednisolone. This is to lower your chances of getting high blood
pressure, having too much water in
your body (fluid retention), or having reduced levels of a chemical
known as potassium in your blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYTIGA
DO NOT TAKE ZYTIGA
-
if you are allergic to abiraterone acetate or any of the other
ingredients of this medicine (listed
in section 6).
-
if you are a woman, especially if pregnant. ZYTIGA is for use in male
patients only.
-
if you have severe liver damage.
-
in combination with Ra-223 (which is used to treat prostate cancer).
Do not take

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZYTIGA 250 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate equivalent to 223
mg of abiraterone.
Excipients with known effect
Each tablet contains 198.65 mg of lactose monohydrate and 6.8 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed
with AA250 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZYTIGA is indicated with prednisone or prednisolone for:

the treatment of newly diagnosed high risk metastatic hormone
sensitive prostate cancer
(mHSPC) in adult men in combination with androgen deprivation therapy
(ADT) (see section
5.1)

the treatment of metastatic castration resistant prostate cancer
(mCRPC) in adult men who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom
chemotherapy is not yet clinically indicated (see section 5.1)

the treatment of mCRPC in adult men whose disease has progressed on or
after a
docetaxel-based chemotherapy regimen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be prescribed by an appropriate
healthcare professional.
Posology
The recommended dose is 1 000 mg (four 250 mg tablets) as a single
daily dose that must not be taken
with food (see “Method of administration” below). Taking the
tablets with food increases systemic
exposure to abiraterone (see sections 4.5 and 5.2).
_Dosage of prednisone or prednisolone_
For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily.
For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily.
Medical castration with luteinising hormone releasing hormone (LHRH)
analogue should be continued
during treatment in patients not surgically castrated.
_Recommended monitoring_
Serum transaminases should be measured prior to starting treatment,
every two weeks for the first
three months of tre