Erleada

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

apalutamide

Tillgänglig från:

Janssen-Cilag International NV

ATC-kod:

L02BB05

INN (International namn):

apalutamide

Terapeutisk grupp:

Endocrine therapy

Terapiområde:

Prostatic Neoplasms

Terapeutiska indikationer:

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.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

Produktsammanfattning:

Revision: 11

Bemyndigande status:

Authorised

Tillstånd datum:

2019-01-14

Bipacksedel

81
B. PACKAGE LEAFLET
82
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLEADA 60 MG FILM-COATED TABLETS
apalutamide
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 Erleada is and what it is used for
2.
What you need to know before you take Erleada
3.
How to take Erleada
4.
Possible side effects
5.
How to store Erleada
6.
Contents of the pack and other information
1.
WHAT ERLEADA IS AND WHAT IT IS USED FOR
WHAT ERLEADA IS
Erleada is a cancer medicine that contains the active substance
‘apalutamide’.
WHAT ERLEADA IS USED FOR
It is used to treat adult men with prostate cancer that:

has metastasised 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 metastasised 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 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 cells from growing and dividing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLEADA
DO NOT TAKE ERLEADA

if you are allergic to apalutamide or any of the other ingredients of
this medicine (listed in
section 6).

if you are a woman who is pregnant or may become pregnant (see the
Pregnancy and
contraception section below for more informatio

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Erleada 60 mg 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 (17 mm long x 9 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. For the most common adverse reactions, (see section 4.8).
_Special populations_
_Elderly_
No dose adjustment is necessary for elderly patients (see sections 5.1
and 5.2).
3
_Renal impairment_
No dose adjustment is necessary for patients with mild to modera