Cabometyx

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cabozantinib (s)-malate

Saatavilla:

Ipsen Pharma

ATC-koodi:

L01EX07

INN (Kansainvälinen yleisnimi):

cabozantinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Renal Cell; Carcinomas, Hepatocellular

Käyttöaiheet:

Renal Cell Carcinoma (RCC)Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.Hepatocellular Carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

Tuoteyhteenveto:

Revision: 18

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-09-09

Pakkausseloste

54
B. PACKAGE LEAFLET
55
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
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 in adults to treat:
-
advanced kidney cancer called advanced 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 cance

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
3
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