Xtandi 40mg Soft Capsules

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

Enzalutamide

Tersedia dari:

Astellas Pharma Malaysia Sdn Bhd

INN (Nama Internasional):

Enzalutamide

Unit dalam paket:

56capsule Capsules; 112capsule Capsules; 112capsule Capsules

Diproduksi oleh:

Catalent Pharma Solutions, LLC

Selebaran informasi

XTANDI
® SOFT CAPSULES
Enzalutamide (40mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What _Xtandi_
_®_
is used for
2.
How _Xtandi_
®
works
3.
Before you use _Xtandi_
_®_
4.
How to use _Xtandi_
_®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Xtandi_
_®_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1. WHAT _XTANDI_
_®_ IS USED FOR
Xtandi
®
contains the active substance
enzalutamide. Xtandi
®
is used to treat
adult 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.
2. HOW _XTANDI_
® WORKS
Xtandi
®
is a medicine that works by
blocking the activity of hormones
called androgens (such as
testosterone). By blocking androgens,
enzalutamide stops prostate cancer
cells from growing and dividing.
3. BEFORE YOU USE _XTANDI_
_®_
_When you must not use it _

If you are allergic to enzalutamide
or any of the other ingredients of
this medicine listed in section
‘_Ingredients’ _

If you are pregnant or may become
pregnant (see ‘_Pregnancy, breast-_
_feeding and fertility’_)
_ _
_Before you start use it _
Warnings and precautions_ _
Seizure
Seizures were reported in 5 in every
1,000 people taking Xtandi
®
, and
fewer than 3 in every 1,000 people
taking placebo (see ‘_Taking other _
_medicines_’ in this section and section
‘_Side effects_’).
If you are taking a medicine that can
cause seizures or that can increase the
susceptibility for having seizures (see
‘_Taking other medicines_’).
If you have a seizure during treatment:
See your doctor as soon as possible.
Your doctor may decide that you
should stop taking Xtandi
®
.
Posterior Reversible Encephalopathy
Syndrome (PRES) _ _
There have been rare reports of PRES,
a rare, reversible condition involving
the brain, in patients treated with
Xtandi
®
. I

Karakteristik produk

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.
Excipient 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 is indicated for:
•
the treatment of adult men with metastatic hormone-sensitive prostate
cancer (mHSPC) in
combination with androgen deprivation therapy (ADT) (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
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg 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 the 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.
2
_ _
_Concomitant use with strong CYP2C8 inhibitors _
The concomitant use of strong CYP2C8 inhibitors should be avoided if
possible