CABOMETYX 60mg film-coated tablets

国家: 马来西亚

语言: 英文

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

有效成分:

Cabozantinib (S)-malate

可用日期:

ZUELLIG PHARMA SDN BHD

INN（国际名称）:

Cabozantinib (S)-malate

每包单位数:

30 Tablets

厂商:

PATHEON INC

资料单张

CABOMETYX
TM
Film-coated Tablets
Cabozantinib (20mg, 40mg, 60mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What CABOMETYX is used for
2.
How CABOMETYX works
3.
Before you use CABOMETYX
4.
How to use CABOMETYX
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CABOMETYX
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
11. Serial number
What CABOMETYX is used for
CABOMETYX is a cancer medicine that
contains
the
active
substance
cabozantinib.
It is used in adults to treat:
-
advanced stages of a type of kidney
cancer called renal cell carcinoma
-
liver
cancer
when
a
specific
anticancer medicine (sorafenib) is no
longer
stopping
the
disease
from
progressing.
CABOMETYX
is
also
used
to
treat
locally
advanced
or
metastatic
differentiated thyroid cancer, a type of
cancer in the thyroid gland, in adults when
radioactive
iodine
and
anticancer
medicine
treatments
are
no
longer
stopping the disease from progressing.
CABOMETYX
may
be
given
in
combination
with
nivolumab
for
advanced kidney cancer. It is important
that you also read the package leaflet of
nivolumab. If you
have any questions
about these medicines, please ask your
doctor.
How CABOMETYX works
CABOMETYX
blocks
the
action
of
proteins called receptor tyrosine kinases
(RTKs), which are involved in the growth
of cells and the development of new blood
vessels that supply them. These proteins
can be present in high amounts in cancer
cells,
and
by
blocking
their
action
CABOMETYX this medicine can slow
down the rate at which the tumour grows
and help to cut off the blood supply that
the cancer needs.
Before you use CABOMETYX
 When you must not use it
if you are allergic to cabozantinib or any
of the other ingredients of this medicine
(listed under Ingredients).
Pregnancy and lactation
Avoid becoming pregnant while being
treated with CABOMETYX. If you or
your partner could become pregnant, use
adequate contraception during treatment
and for at least 4 months after treatment
h

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
CABOMETYX 20 mg film-coated tablets
CABOMETYX 40 mg film-coated tablets
CABOMETYX 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CABOMETYX 20 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to
20 mg cabozantinib.
_Excipients with known effect _
Each film-coated tablet contains 15.54 mg lactose.
CABOMETYX 40 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to
40 mg cabozantinib.
_Excipients with known effect _
Each film-coated tablet contains 31.07 mg lactose.
CABOMETYX 60 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to
60 mg cabozantinib.
_Excipients with known effect _
Each film-coated tablet contains 46.61 mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
CABOMETYX 20 mg film-coated tablets
The tablets are yellow round with no score, and debossed with “XL”
on one side and “20” on the
other side of the tablet.
CABOMETYX 40 mg film-coated tablets
The tablets are yellow triangle shaped with no score, and debossed
with “XL” on one side and “40”
on the other side of the tablet.
CABOMETYX 60 mg film-coated tablets
The tablets are yellow oval shaped with no score, and debossed with
“XL” on one side and “60” on
the other side of the tablet.
FORMATTED: Font: Not Italic
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal Cell Carcinoma (RCC)
CABOMETYX is indicated as monotherapy for advanced renal cell
carcinoma
-
as first line treatment of adult patients with intermediate or poor
risk (see section 5.1)
-
in adults following prior vascular endothelial growth factor
(VEGF)-targeted therapy (see
section 5.1).
CABOMETYX, in combination with nivolumab, is indicated for the
first-line treatment of advanced
renal cell carcinoma in adults (see section 5.1).
Hepatocellular Carcinoma (HCC)
CABOMETYX is indicated as monotherapy for the treatment of
hepatocellul