Cabometyx 40mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Cabozantinib s-malate

제공처:

Ipsen Ltd

ATC 코드:

L01XE26

INN (International Name):

Cabozantinib s-malate

복용량:

40mg

약제 형태:

Tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 08010500; GTIN: 3582186003831

환자 정보 전단

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABOMETYX 20 MG FILM-COATED TABLETS
CABOMETYX 40 MG FILM-COATED TABLETS
CABOMETYX 60 MG FILM-COATED TABLETS
cabozantinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CABOMETYX is and what it is used for
2.
What you need to know before you take CABOMETYX
3.
How to take CABOMETYX
4.
Possible side effects
5.
How to store CABOMETYX
6.
Contents of the pack and other information
1.
WHAT CABOMETYX IS AND WHAT IT IS USED FOR
WHAT CABOMETYX IS
CABOMETYX is a cancer medicine that contains the active substance
cabozantinib. It is used to treat
advanced stages of a type of kidney cancer called renal cell carcinoma
in adults.
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
can slow down the rate at which the tumour grows and help to cut off
the blood supply that the cancer
needs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABOMETYX
DO NOT TAKE CABOMETYX
-
if you are allergic to cabozantinib or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk

제품 특성 요약

OBJECT 1
CABOMETYX 20MG
Summary of Product Characteristics Updated 18-May-2018 | Ipsen Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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.
4. Clinical particulars
4.1 Therapeutic indications
CABOMETYX is indicated for the treatment of advanced renal cell
carcinoma (RCC):
- in treatment-naïve adults with intermediate or poor risk (see
section 5.1)
- in adults following prior vascular endothelial growth factor
(VEGF)-t