ZYTIGA

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

ABIRATERONE ACETATE

Verfügbar ab:

SOHO INDUSTRI PHARMASI - Indonesia

INN (Internationale Bezeichnung):

ABIRATERONE ACETATE

Dosierung:

500 MG

Darreichungsform:

TABLET SALUT SELAPUT

Einheiten im Paket:

DUS, 5 AMPLOP @ 1 BLISTER @ 12 TABLET SALUT SELAPUT

Hergestellt von:

JANSSEN CILAG FARMACEUTICAL SpA - Italy

Berechtigungsdatum:

2019-09-12

Fachinformation

1
PRODUCT NAME
ZYTIGA®
(abiraterone acetate)
DOSAGE FORMS AND STRENGTHS
250 mg uncoated Tablet
ZYTIGA uncoated tablets contain 250 mg of abiraterone acetate
White to off-white, oval tablets, debossed with AA250 on one side.
500 mg film-coated tablets
ZYTIGA film-coated tablets contain 500 mg of abiraterone acetate
Purple, oval-shaped, film-coated tablets, debossed with “AA” on
one side and “500” on the other.
For excipients, see _Pharmaceutical Information_ - List of Excipients.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
PHARMACOTHERAPEUTIC GROUP: Other hormone antagonists and related
agents, ATC CODE: L02BX03
_ _
_MECHANISM OF ACTION _
Abiraterone acetate (ZYTIGA) is converted _ in vivo_ to abiraterone,
an androgen biosynthesis inhibitor. Specifically,
abiraterone selectively inhibits the enzyme
17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and
is
required for androgen biosynthesis in testicular, adrenal and
prostatic tumor tissues. It catalyzes the conversion of
pregnenolone
and
progesterone
into
testosterone
precursors,
DHEA
and
androstenedione,
respectively,
by
17α
hydroxylation and cleavage of the C17,20 bond. CYP17 inhibition also
results in increased mineralocorticoid production
by
the
adrenals
(see
_Warnings _
_and _
_Precautions _
_- _
_Hypertension, _
_hypokalemia _
_and _
_fluid _
_retention _
_due _
_to _
_mineralocorticoid excess_).
Androgen-sensitive prostatic carcinoma responds to treatment that
decreases androgen levels. Androgen deprivation
therapies, such as treatment with LHRH agonists or orchiectomy,
decrease androgen production in the testes but do
not affect androgen production by the adrenals or in the tumor.
Treatment with ZYTIGA decreases serum testosterone
to undetectable levels (using commercial assays) when given with LHRH
agonists (or orchiectomy).
_PHARMACODYNAMIC EFFECTS _
ZYTIGA decreases serum testosterone and other androgens to levels
lower than those achieved by the use of LHRH
agonists alone or by orchiectomy. This results from the sele