ERLYAND apalutamide 60 mg film-coated tablet bottle

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

apalutamide, Quantity: 60 mg

Предлага се от:

Janssen-Cilag Pty Ltd

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: silicified microcrystalline cellulose; hypromellose acetate succinate; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black

Начин на приложение:

Oral

Броя в опаковка:

120 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

ERLYAND (apalutamide) is indicated for the treatment of patients with: ? metastatic castration-sensitive prostate cancer (mCSPC) or ? non-metastatic, castration-resistant prostate cancer (nmCRPC)

Каталог на резюме:

Visual Identification: Slightly yellowish green to greyish green, oblong-shaped, film-coated tablets, debossed with AR 60 on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус Оторизация:

Registered

Дата Оторизация:

2018-07-05

Листовка

ERLYAND
®
1

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
ERLYAND
® TABLETS
_apalutamide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERLYAND tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
ERLYAND against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN ERLYAND ASK YOUR
DOCTOR OR HEALTHCARE PROFESSIONAL.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING ERLYAND.
You may need to read it again.
WHAT ERLYAND IS
USED FOR
ERLYAND is an anticancer
medicine that contains the active
substance apalutamide.
ERLYAND is used to treat patients
with prostate cancer that has not
spread to other parts of the body and
no longer responds to a medical or
surgical treatment that lowers
testosterone.
ERLYAND belongs to a group of
medicines called androgen receptor
inhibitors.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU HAVE ANY
QUESTIONS ABOUT WHY ERLYAND
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
−
Before you take ERLYAND
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE ERLYAND:
•
if you are allergic
(hypersensitive) to apalutamide,
or other ingredients of
ERLYAND. See Product
Description at the end of this
leaflet for a list of ingredients.
DO NOT TAKE ERLYAND:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
passed. If you take ERLYAND
after the expiry date it may not
work.
DO NOT TAKE ERLYAND IF YOU ARE
PREGNANT OR MAYBE POTENTIALLY
PREGNANT.
•
ERLYAND is not for use in
women and children.
•
ERLYAND may harm your
unbo

Данни за продукта

CCDS200106
1
ERLYAND (200723) API
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse events at
https://www.tga.gov.au/reporting-problems
.
ERLYAND
®
APALUTAMIDE
A
USTRALIAN
P
RODUCT
I
NFORMATION
1. NAME OF THE MEDICINE
Apalutamide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ERLYAND 60 mg tablets contain 60 mg of apalutamide.
For a full list of excipients, see SECTION 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ERLYAND is supplied as slightly yellowish green to greyish green,
oblong-shaped, film-coated
tablets, debossed with “AR 60” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ERLYAND
(apalutamide)
is
indicated
for
the
treatment
of
patients
with
non
-
metastatic,
castration-resistant prostate cancer (see SECTION 5.1 CLINICAL
TRIALS).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE IN ADULTS
The recommended dose of ERLYAND is 240 mg (four 60 mg tablets)
administered orally once
daily.
Patients should concurrently receive a gonadotropin-releasing hormone
(GnRH) analogue, unless
they have had a bilateral orchiectomy.
METHOD OF ADMINISTRATION
ERLYAND should be administered orally once daily, with or without
food. The tablets should be
swallowed whole.
If the patient misses a dose, it should be taken as soon as possible
on the same day with a return
to the normal schedule on the following day. The patient should not
take extra tablets to make up
the missed dose.
▼
Product Information - Australia
CCDS200106
2
ERLYAND (200723) API
DOSAGE ADJUSTMENT
_ADVERSE EFFECTS _
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse effect, hold dosing until
symptoms improve to ≤ Grade 1 or original grade, then resume at the
same dose or a reduced
dose (180 mg or 120 mg), if warranted.
_HEPATIC INSUFFICIENCY _
No dosage adjustment is necessary for patients with baseline mild
(Child-Pugh class A) or
moderate (Child-Pugh class B) hepatic i