Talzenna 0.25mg Hard Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Talazoparib Tosylate

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Talazoparib Tosylate

Unit dalam pakej:

30 Capsules

Dikeluarkan oleh:

Excella GmbH & Co.KG

Risalah maklumat

Pfizer Confidential
_ _
_ _
_ _
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TALZENNA HARD CAPSULES
Talazoparib (0.25 mg, 1 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Talzenna is used for
2.
How Talzenna works
3.
Before you use Talzenna
4.
How to use Talzenna
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Talzenna
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT TALZENNA IS USED FOR
Talzenna is an anticancer drug used
for treating adult patients with
mutations/changes in the genes
(BRCA1/2 mutation and HER2-
negative locally advanced or
metastatic breast cancer) which are
responsible for breast cancer. Patients
should have been treated prior with
another anticancer drug such as
anthracycline or a taxane. Patients
with breast cancer due to changes in
the hormones should be first treated
with a hormone-based therapy, or
identified to be unsuitable for
hormone-based therapy.
HOW TALZENNA WORKS
Talzenna inhibits the activity of PARP
(PARP1, and PARP2) enzymes which
is involved in development of cancer.
BEFORE YOU USE TALZENNA
-
_When you must not use it _
Do not take Talzenna
•
If you are allergic to talazoparib
or any of the other ingredients in
Talzenna.
•
If you are breastfeeding
_Pregnancy and lactation _
Your doctor may do a pregnancy test
before you start treatment with
Talzenna and may also suggest you to
use effective birth control
(contraception) during treatment and
for at least 7 months after your last
dose of Talzenna. Talk to your doctor
about birth control methods that may
be right for you during this time.
You should not become pregnant
during treatment with Talzenna
because this medicine could harm the
baby. If you become pregnant while
taking this medicine, you should
immediately talk to your doctor.
It is not known if Talzenna passes into
your breast milk. Breast-feeding is not
recommended during treatment with
Talzenna and for at least 1 month after
the final dose.
-
_Before you start to use it _
Be

Ciri produk

1
PFIZER
TALZENNA
(TALAZOPARIB)
1.
NAME OF THE MEDICINAL PRODUCT
Talzenna 0.25 mg hard capsules
Talzenna 1 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Talzenna 0.25 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg
talazoparib.
Talzenna 1 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 1 mg
talazoparib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Talzenna 0.25 mg hard capsules
Opaque, size #4 hard capsule with an ivory cap (printed with
“Pfizer” in black) and a white body
(printed with “TLZ 0.25” in black).
Talzenna 1 mg hard capsules
Opaque, size #4 hard capsule with a light red cap (printed with
“Pfizer” in black) and a white
body (printed with “TLZ 1” in black).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Talzenna is indicated as monotherapy for
the treatment of adult
patients with
germline
BRCA1/2-mutations, who have HER2-negative locally advanced or
metastatic breast cancer.
Patients should have been previously treated with an anthracycline
and/or a taxane in the
(neo)adjuvant, locally advanced or metastatic setting unless patients
were not suitable for these
treatments (see section 5.1 Pharmacodynamic properties). Patients with
hormone receptor (HR)-
positive breast cancer should have been treated with a prior
endocrine-based therapy, or be
considered unsuitable for endocrine-based therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Talzenna should be initiated and supervised by a
physician experienced in the
use of anticancer medicinal products.
Patients should be selected for the treatment of breast cancer with
Talzenna based on the presence
of deleterious or suspected deleterious germline BRCA mutations
determined by an experienced
laboratory using a validated test method.
2
Genetic counselling for patients with BRCA mutations should be
performed according to local
regulations, as applicable.
Posology
The recommended dose is 1 mg t