VENCLEXTA TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VENETOCLAX

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

VENETOCLAX

Unit dalam pakej:

Pack of 7 tablets Tablets

Dikeluarkan oleh:

Abbvie Ireland NL B.V

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
VENCLEXTA FILM-COATED TABLETS
Venetoclax 10mg, 50mg & 100mg
WHAT IS IN THIS LEAFLET
1.
What Venclexta is used for
2.
How Venclexta works
3.
Before you use Venclexta
4.
How to use Venclexta
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Venclexta
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT VENCLEXTA IS USED FOR
VENCLEXTA is a prescription medicine
used
to
treat
people
with
chronic
lymphocytic leukaemia (CLL) with 17p
deletion, who have received at least one
prior treatment.
VENCLEXTA is taken in combination
with rituximab or alone, to treat patients
with CLL when the disease comes back
after it has been treated.
VENCLEXTA is taken in combination
with obinutuzumab to treat patients with
CLL that has not been treated before.
VENCLEXTA is taken, in combination
with azacitadine or decitabine or low-
dose cytarabine, to treat adults with
newly-diagnosed acute myeloid
leukaemia (AML) who are 75 years of
age or older, or have other medical
conditions that prevent the use of
standard chemotherapy.
It is not known if VENCLEXTA is safe
and effective in children.
HOW VENCLEXTA WORKS
VENCLEXTA
works
by
blocking
a
protein in the body called “BCL-2”. This
protein helps cancer cells survive.
Blocking this protein helps to kill and
lower the number of cancer cells. It also
slows down the worsening of the disease.
BEFORE YOU USE VENCLEXTA
VENCLEXTA CAN CAUSE TUMOR LYSIS
SYNDROME (TLS), A SERIOUS SIDE EFFECT
THAT CAN LEAD TO DEATH.
TLS is caused by
the fast breakdown of cancer cells. As
cancer cells are destroyed, they release
their contents, leading to high levels of
certain chemicals (potassium, uric acid,
phosphorus) and low levels of calcium in
the blood. High, or low, levels of these
chemicals can cause serious damage to
kidneys and other organs,and may lead to
sudden kidney failure or death. The
changes in your blood that could lead to
TLS may have no symptoms. Having
your blood tested is importan

Ciri produk

PRODUCT PACKAGE INSERT
PRODUCT NAME
Venetoclax
TRADE NAME
Venclexta Film-Coated Tablets 10mg
Venclexta Film-Coated Tablets 50mg
Venclexta Film Coated Tablets 100mg
DESCRIPTION AND COMPOSITION
Venclexta tablets for oral administration are supplied as pale yellow
or beige tablets that contain
10, 50, or 100 mg venetoclax as the active ingredient.
Each
tablet
also
contains
the
following
inactive
ingredients:
copovidone,
colloidal
silicon
dioxide, polysorbate 80, sodium stearyl fumarate, and calcium
phosphate dibasic.
In addition, the 10 mg and 100 mg coated tablets include the
following: iron oxide yellow,
polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.
The 50 mg coated tablets
include the following: iron oxide yellow, iron oxide red, iron oxide
black, polyvinyl alcohol,
polyethylene glycol, talc, and titanium dioxide.
Each tablet is debossed with “V” on one side and “10”,
“50” or “100” corresponding to the tablet
strength on the other side.
Venetoclax is a light yellow to dark yellow solid with the empirical
formula C
45
H
50
ClN
7
O
7
S and
a molecular weight of 868.44. Venetoclax has very low aqueous
solubility.
Venetoclax is described chemically as
4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-
yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide)
and has the
following chemical structure:
INDICATIONS
VENCLEXTA in combination with rituximab is indicated for the treatment
of adult patients with
chronic lymphocytic leukaemia (CLL) who have received at least one
prior therapy.
VENCLEXTA in combination with obinutuzumab is indicated for the
treatment of adult patients
with previously untreated CLL.
VENCLEXTA (venetoclax) monotherapy is indicated for the treatment of
patients with chronic
lymphocytic leukaemia (CLL) with 17p deletion who have received at
least one prior therapy, or
patients with CLL without 17p deletion who have received at least one
prior therapy and for
whom there are