ZYBERA 250 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ABIRATERONE 250,0 mg

Authorization status:

Registered

Patient Information leaflet

Page 1 of 18
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
ZYBERA 250 MG TABLETS
ABIRATERONE ACETATE
ZYBERA 250 MG CONTAINS 145 MG LACTOSE MONOHYDRATE (SUGAR)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZYBERA 250
MG
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
ZYBERA 250 MG has been prescribed for you personally and you should
not share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET:
1. WHAT ZYBERA 250 MG IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYBERA 250 MG
3. HOW TO TAKE ZYBERA 250 MG
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZYBERA 250 MG
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ZYBERA 250 MG IS AND WHAT IT IS USED FOR:
ZYBERA 250 MG 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. ZYBERA
250 MG stops your body
from making testosterone; this can slow the growth of prostate cancer.
When
ZYBERA 250 MG 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
S4
Page 2 of 18
therapy).
When you take ZYBERA 250 MG 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 ZYBERA 250 MG:
DO NOT TAKE ZYBERA 250 MG:
•
If you are hypersensitive (allergic) to abiraterone acetate or any of
the other ingredients of ZYBERA 250
MG (listed in SECTION 6).
•
if you are a woman, especially if pregnant. ZYBERA 250 MG is for use
in male patients only.
•
if you have severe liver damage.
•
in combination with Ra-223 (which is us

Summary of Product characteristics

PAGE 1 OF 18
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S4
1. NAME OF THE MEDICINE:
ZYBERA 250 MG (tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains 250 mg of abiraterone acetate.
_Excipient with known effect: _contains 145 mg lactose monohydrate
(sugar) per tablet.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM:
Tablets
White Modified Oval shaped film coated tablet, debossed with "TEVA" on
one side and "1125" on the
other side.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
ZYBERA 250 MG is indicated with low-dose corticosteroids (prednisone
or prednisolone) in adult
males for the treatment of:
•
high-risk metastatic hormone treatment naïve prostate cancer (mHNPC)
or newly diagnosed high-
risk metastatic hormon
e sensitive prostate cancer (mHSPC) in combination with androgen
deprivation therapy (LHRH agonist or surgical castration).
High-risk is defined as having at least 2 of the following 3 risk
factors:
(1)
Gleason score of ≥ 8;
(2)
presence of 3 or more bone lesions;
(3)
presence of measurable visceral (excluding lymph node disease)
metastasis.
PAGE 2 OF 18
•
metastatic castration resistant prostate cancer with bone metastases
who are asymptomatic or
mildly symptomatic after failure of androgen deprivation therapy in
whom chemotherapy is not yet
clinically indicated.
•
metastatic advanced prostate cancer (castration resistant prostate
cancer) who have received
prior chemotherapy containing docetaxel.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
The recommended dose of ZYBERA 250 MG is 1 g (four 250 mg tablets) as
a single daily dose that
MUST NOT BE TAKEN WITH FOOD. The tablets should be swallowed whole
with water. Taking ZYBERA
250 MG with food increases systemic exposure to abiraterone (see
SECTION 4.5 and SECTION 5.2).
Patients
should
be
maintained
on
ZYBERA
250
MG
until
radiographic
progression
and
symptomatic/clinical progression and until PSA progression (confirmed
25 % incre
ase over the
patient’s baseline/nadir).
_Dosage of prednison