CABOMETYX 60 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CABOZANTINIB AS (S) MALATE

Available from:

MEDISON PHARMA LTD

ATC code:

L01XE26

Pharmaceutical form:

FILM COATED TABLETS

Composition:

CABOZANTINIB AS (S) MALATE 60 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

IPSEN PHARMA, FRANCE

Therapeutic area:

CABOZANTINIB

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, per IMDC criteria.- 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 with Child-Pugh Class A hepatic impairment who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

Authorization date:

2023-10-31

Patient Information leaflet

CABO-PIL-0123-V1
Page 1 of 10
Cabometyx-PIL-ENG-D64-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
CABOMETYX
® 20 MG
CABOMETYX
® 40 MG
CABOMETYX
® 60 MG
FILM-COATED TABLETS
NAME AND QUANTITY OF ACTIVE INGREDIENTS
Cabometyx 20 mg
Each tablet contains 20 mg cabozantinib (as (_S_)-malate)
Cabometyx 40 mg
Each tablet contains 40 mg cabozantinib (as (_S_)-malate)
Cabometyx 60 mg
Each tablet contains 60 mg cabozantinib (as (_S_)-malate)
Inactive ingredients and allergens in this medicine - See section 6
"ADDITIONAL
INFORMATION". See also "IMPORTANT INFORMATION ABOUT SOME OF THE
MEDICINE'S
INGREDIENTS" in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
the doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them even if it seems to you that their illness is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
KIDNEY CANCER (RENAL CELL CARCINOMA)
Cabometyx is indicated as monotherapy for an advanced kidney cancer
called advanced
renal cell
carcinoma:
-
as first-line treatment of adult patients who are at moderate or high
risk according to the
IMDC classification.
-
in adult patients who have been previously treated with VEGF (vascular
endothelial
growth factor) inhibitors.
Cabometyx, in combination with nivolumab, is indicated for the
first-line treatment of
advanced renal cell carcinoma in adults.
LIVER CANCER (HEPATOCELLULAR CARCINOMA)
Cabometyx is used as monotherapy to treat a type of liver cancer
called carcinoma in adults
with impaired liver function (Child-Pugh Class A) who have been
previously treated with
sorafenib.
CABO-PIL-0123-V1
Page 2 of 10
Cabometyx-PIL-ENG-D64-F
THYROID CANCER (DTC)
Cabometyx is used as monotherapy for the treatment of adult patients
with locally advanced
or metastatic differen

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cabometyx
®
20 mg
Cabometyx
®
40 mg
Cabometyx
®
60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cabometyx 20 mg
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
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
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 tablets
Cabometyx 20 mg
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
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
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
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, per IMDC criteria.
- 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 (see section 5.1).
Hepatocellular carcinoma (HCC)
Cabometyx is indicated as monotherapy for the treatment of
hepatocellular carcinoma (HCC), in adults with
Child-Pugh Class A hepatic impairment who have previously been treated
with sorafenib.
Differentiated thyroid carcinoma (DTC)
CABOMETYX is indicated a