Abiraterone Krka
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
08-03-2023
Summary of Product characteristics
(SPC)
08-03-2023
Public Assessment Report
(PAR)
23-11-2021
Active ingredient:
abiraterone acetate
Available from:
Krka, d.d., Novo mesto
ATC code:
L02BX03
INN (International Name):
abiraterone acetate
Therapeutic group:
Endocrine therapy
Therapeutic area:
Prostatic Neoplasms
Therapeutic indications:
Abiraterone Krka 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.
Product summary:
Revision: 2
Authorization status:
Authorised
Authorization date:
2021-06-24
Patient Information leaflet
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABIRATERONE KRKA 500 MG FILM-COATED 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 Abiraterone Krka is and what it is used for
2.
What you need to know before you take Abiraterone Krka
3.
How to take Abiraterone Krka
4.
Possible side effects
5.
How to store Abiraterone Krka
6.
Contents of the pack and other information
1.
WHAT ABIRATERONE KRKA IS AND WHAT IT IS USED FOR
Abiraterone Krka 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. Abiraterone Krka
stops your body from making
testosterone; this can slow the growth of prostate cancer.
When Abiraterone Krka 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 ABIRATERONE KRKA
DO NOT TAKE ABIRATERONE KRKA
-
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. Abiraterone Krka is for
use in mal
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Abiraterone Krka 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg abiraterone acetate.
Excipient(s) with known effect:
Each film-coated tablet contains 253.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Grey violet to violet, oval, biconvex film-coated tablets, with
dimensions approximately of 20 mm
long x 10 mm wide.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abiraterone Krka 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 (two 500 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, Abiraterone Krka is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, Abiraterone Krka 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 treatmen
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