Trezilent 150mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Alpelisib

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Alpelisib

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

TREZILENT
®
Film-coated Tablets
Alpelisib (50mg, 150mg, 200mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Trezilent
®
is used for
2.
How Trezilent
®
works
3.
Before you use Trezilent
®
4.
How to use Trezilent
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Trezilent
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TREZILENT
®
IS USED FOR
Trezilent
®
is a prescription medicine
used in combination with the medicine
fulvestrant to treat women who have
gone through menopause and men:
•
who have hormone receptor (HR)-
positive, human epidermal growth
factor receptor 2 (HER2)-negative
advanced breast cancer or breast
cancer that has spread to other parts
of the body (metastatic), with an
abnormal phosphatidylinositol-3-
kinase catalytic subunit alpha
(PIK3CA) gene,
AND
•
whose disease has progressed on or
after endocrine therapy.
Your healthcare provider will test your
cancer for an abnormal “PIK3CA” gene
to make sure that Trezilent
®
is right for
you.
It is not known if Trezilent
®
is safe and
effective in children.
HOW TREZILENT
® WORKS
Trezilent
®
works by blocking the effects
of enzymes called phosphatidylinositol-3-
kinases (PI3K) which signal cancer cells
to grow and multiply. By blocking these
enzymes, Trezilent
®
can reduce cancer
cell growth and the ability to make new
cancer cells, and can destroy cancer cells.
Trezilent
®
has to be used together with
another medicine called fulvestrant.
If you have any questions about how
Trezilent
®
works or why this medicine
has been prescribed for you, ask your
doctor, pharmacist or healthcare provider.
BEFORE YOU USE TREZILENT
®
-
When you must not use it
Do not take Trezilent
®
if you have had a
severe allergic reaction to Trezilent
®
or
are allergic to any of the ingredients in
Trezilent
®
.
See the end of this Patient Information
leaflet
for
a
complete
list
of
the
ingredients in Trezilent
®
. See “Things to
be careful of” fo

Ciri produk

FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
TREZILENT is indicated in combination with fulvestrant for the
treatment of postmenopausal women, and
men, with hormone receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative,
PIK3CA-mutated, advanced or metastatic breast cancer following
progression on or after an endocrine-based
regimen.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for the treatment of HR-positive, HER2-negative
advanced or metastatic breast cancer with
TREZILENT, based on the presence of one or more PIK3CA mutations in
tumor tissue or plasma specimens
_[see Clinical Studies (14)]_
. If no mutation is detected in a plasma specimen, test tumor tissue.
2.2
DOSAGE AND ADMINISTRATION
The recommended dose of TREZILENT is 300 mg (two 150 mg film-coated
tablets) taken orally, once daily,
with food
_[see Clinical Pharmacology (12.3)]_
.
Continue treatment until disease progression or unacceptable toxicity
occurs
_[see Dosage and Administration _
_(2.3)]_
.
Patients should take their dose of TREZILENT at approximately the same
time each day.
Swallow TREZILENT tablets whole (tablets should not be chewed, crushed
or split prior to swallowing). No
tablet should be ingested if it is broken, cracked, or otherwise not
intact.
If a dose of TREZILENT is missed, it can be taken with food within 9
hours after the time it is usually taken.
After more than 9 hours, skip the dose for that day. The next day,
take TREZILENT at the usual time.
If the patient vomits after taking the dose, advise the patient not to
take an additional dose on that day, and to
resume the dosing schedule the next day at the usual time.
When given with TREZILENT, the recommended dose of fulvestrant is 500
mg administered on Days 1, 15,
and 29, and once monthly thereafter. Refer to the Full Prescribing
Information for fulvestrant.
2.3
DOSE MODIFICATIONS FOR ADVERSE REACTIONS
The recommended dose modifications for adverse reactions (ARs) are
listed in Table 1.
TABLE 1: TREZILENT DOSE REDUCTION G