Erleada 60mg Film-Coated Tablets

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

Apalutamide

Beschikbaar vanaf:

JOHNSON & JOHNSON SDN. BHD.

INN (Algemene Internationale Benaming):

Apalutamide

Eenheden in pakket:

120 Tablets

Geproduceerd door:

Janssen Ortho LLC

Bijsluiter

ERLEADA
® FILM-COATED TABLETS
Apalutamide (60mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ERLEADA
®
is used for
2.
How ERLEADA
®
works
3.
Before you use ERLEADA
®
4.
How to use ERLEADA
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of ERLEADA
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT ERLEADA
® IS USED FOR
ERLEADA
®
is used to treat adult men
patients with prostate cancer that:
•
has spread to other parts of the
body and still responds to
medical or surgical treatments
that lower testosterone (also
called hormone-sensitive
prostate cancer).
•
has not spread to other parts of
the body and no longer responds
to medical or surgical treatment
that lowers testosterone (also
called castration-resistant
prostate cancer).
HOW ERLEADA
® WORKS
ERLEADA
®
contains the active substance
apalutamide. ERLEADA
®
works by
blocking the activity of hormones called
androgens (such as testosterone).
Androgens can cause the cancer to grow.
By blocking the effect of androgens,
apalutamide stops prostate cancer from
growing and dividing.
BEFORE YOU USE ERLEADA
®
-
_When you must not use it _
Do not take ERLEADA
®
if you are
allergic to apalutamide or any of the
other ingredients of this medicine (listed
in Product Description)
_Woman, infants, and children_
ERLEADA
®
is not for use in women
and children under 18 years of age.
_ _
_Pregnancy _
ERLEADA
®
may harm your unborn
baby. Do not take ERLEADA
®
if you
are pregnant or may become pregnant.
_Breastfeeding_
It is unknown whether apalutamide/
metabolites are excreted in human milk.
A risk to the suckling child cannot be
excluded. ERLEADA
®
should not be used
during breastfeeding.
_Fertility _
ERLEADA
®
may impair fertility in
males.
_Contraception_
If you are having sex with a pregnant
woman – use a condom to protect the
unborn baby.
If you are having sex with a woman who
can become pregnant – use a condom
and another highly effective method o

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
ERLEADA
_®_
(apalutamide) 60mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg of apalutamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Slightly yellowish to greyish green, oblong-shaped, film-coated
tablets (16.7 mm long x 8.7 mm
wide), debossed with “AR 60” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ERLEADA
_®_
is indicated:
•
in adult men for the treatment of non-metastatic castration-resistant
prostate cancer (nmCRPC)
who are at high risk of developing metastatic disease (see section
5.1).
•
in adult men for the treatment of metastatic hormone-sensitive
prostate cancer (mHSPC) in
combination with androgen deprivation therapy (ADT) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment
with
apalutamide
should
be
initiated
and
supervised
by
specialist
physicians
experienced in the medical treatment of prostate cancer.
Posology
The recommended dose is 240 mg (four 60 mg tablets) as an oral single
daily dose.
Medical castration with gonadotropin releasing hormone analogue
(GnRHa) should be continued
during treatment in patients not surgically castrated.
If a dose is missed, it should be taken as soon as possible on the
same day with a return to the
normal schedule the following day. Extra tablets should not be taken
to make up the missed dose.
If a ≥ Grade 3 toxicity or an intolerable adverse reaction is
experienced by the patient, dosing
should be held rather than permanently discontinuing treatment until
symptoms improve to
≤ Grade 1 or original grade, then should be resumed at the same dose
or a reduced dose (180 mg
or 120 mg), if warranted. If the toxicity recurs at Grade 3 or higher,
then the dose of apalutamide
should be reduced to the next lower dose level (from 240 mg to 180 mg,
and from 180 mg to 120
mg). A maximum of 2 dose level reductions (to 120 mg) is allowed. If
further dose reductions are
needed, apa