XTANDI 40 MG TABLETS

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ENZALUTAMIDE

Διαθέσιμο από:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

Φαρμακολογική κατηγορία (ATC):

L02BB04

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

ENZALUTAMIDE 40 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS

Θεραπευτική περιοχή:

ENZALUTAMIDE

Θεραπευτικές ενδείξεις:

Xtandi is indicated for:• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).• the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.•the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy

Ημερομηνία της άδειας:

2022-06-22

Φύλλο οδηγιών χρήσης

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
XTANDI 40MG
XTANDI 80MG
FILM COATED TABLETS
COMPOSITION:
Each Xtandi 40 mg film coated tablet contains: enzalutamide 40 mg.
Each Xtandi 80 mg film coated tablet contains: enzalutamide 80 mg.
INACTIVE INGREDIENTS AND ALLERGENS - see section 6 ‘Further
information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them even if it seems to you that their ailment is
similar.
The medicine is intended for adult men only.
The
medicine is not intended for use by women
.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to treat men with prostate cancer that:
-
No longer responds to a hormone therapy or surgical treatment to lower
testosterone
Or
-
Has spread to other parts of the body and responds to a hormone
therapy or surgical
treatment to lower testosterone.
THERAPEUTIC GROUP: hormone antagonists and related agents,
anti-androgens.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
-
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients
included in the medicine (see section 6 ‘Further information’).
-
you are pregnant or may become pregnant (see ‘Pregnancy,
breastfeeding and
fertility’).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Seizures:
Seizures were reported in 5 in every 1,000 people taking Xtandi, and
in fewer than 3 in every
1,000 people receiving placebo (see ‘Drug interactions’ below and
section 4 ‘Side effects’).
If you are taking medicines that may cause seizures or that can
increase the susceptibility for
having seizures (see ‘Drug interactions’ below).
If you have a seizure during treatment:
2
See your doctor as

Αρχείο Π.Χ.Π.

1
1.
NAME OF THE MEDICINAL PRODUCT
Xtandi 40 mg
Xtandi 80 mg
Film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xtandi 40 mg, film-coated tablets
Each film-coated tablet contains 40 mg of enzalutamide.
Xtandi 80 mg, film-coated tablets
Each film-coated tablet contains 80 mg of enzalutamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Xtandi 40 mg
Yellow round – film-coated tablets, debossed with E 40.
Xtandi 80 mg
Yellow oval – film-coated tablets, debossed with E 80.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xtandi is indicated for:
•
the treatment of adult men with metastatic hormone-sensitive prostate
cancer
(mHSPC) in combination with androgen deprivation therapy (see section
5.1).
•
the treatment of adult men with high-risk non-metastatic
castration-resistant prostate
cancer (CRPC) (see section 5.1).
•
the treatment of adult men with metastatic CRPC 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 adult men with metastatic CRPC whose disease has
progressed on
or after docetaxel therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with enzalutamide should be initiated and supervised by
specialist physicians
experienced in the medical treatment of prostate cancer.
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg film-coated
tablets or two
80 mg film-coated tablets) 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.
2
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 the usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, do