XTANDI

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

ENZALUTAMIDE

Tillgänglig från:

MEPROFARM - Indonesia

INN (International namn):

ENZALUTAMIDE

Dos:

40 MG

Läkemedelsform:

KAPSUL LUNAK

Enheter i paketet:

DUS, 28 SACHET @ 1 BLISTER @ 4 KAPSUL LUNAK

Tillverkad av:

ASTELLAS PHARMA MANUFACTURING, Inc - USA

Tillstånd datum:

2019-12-27

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Xtandi™ 40 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 40 mg of enzalutamide
Excipients with known effect:
Each soft capsule contains 57.8 mg of sorbitol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Soft capsule.
White to off-white oblong soft capsules (approximately 20 mm x 9 mm)
imprinted with “ENZ” in
black ink on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Xtandi in combination with androgen deprivation therapy is indicated
for the treatment of
adult men with metastatic castration-resistant prostate cancer who are
asymptomatic or
mildly symptomatic after failure of androgen deprivation therapy in
whom chemotherapy is
not clinically indicated.

Xtandi is indicated for the second line treatment of adult men with
metastatic castration-
resistant prostate cancer whose disease has progressed on or after
docetaxel therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg soft capsules)
as a single oral daily dose.
Medical
castration
with
a
luteinising
hormone-releasing
hormone
(LHRH)
analogue
should
be
continued during treatment of patients not surgically castrated.
If a patient misses taking Xtandi at the usual time, the prescribed
dose should be taken as close as
possible to the usual time. If a patient misses a dose for a whole
day, treatment should be resumed the
following day with usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, dosing should be
withheld for one week or until symptoms improve to ≤ Grade 2, then
resumed at the same or a reduced
dose (120 mg or 80 mg) if warranted.
_Concomitant use with strong CYP2C8 inhibitors _
The concomitant use of strong CYP2C8 inhibitors should be avoided if
possible. If patients must be
co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide
should be reduced to 80 mg
once daily. If co-administration of the strong