LENVIMA 4 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

LENVATINIB AS MESILATE

Διαθέσιμο από:

EISAI ISRAEL LTD., ISRAEL

Φαρμακολογική κατηγορία (ATC):

L01XE29

Φαρμακοτεχνική μορφή:

HARD CAPSULE

Σύνθεση:

LENVATINIB AS MESILATE 4 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

EISAI MANUFACTURING LIMITED, UK

Θεραπευτική περιοχή:

LENVATINIB

Θεραπευτικές ενδείξεις:

LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).LENVIMA is indicated in combination with everolimus for the treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.Lenvima, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.LENVIMA is indicated in combination with pembrolizumab for the first-line treatment of adult patients with advanced RCC.

Ημερομηνία της άδειας:

2021-01-31

Φύλλο οδηγιών χρήσης

PHARMA CODE
READ DIRECTION
2006197
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied upon a physician's
prescription only
LENVIMA® 4 MG
HARD CAPSULES
COMPOSITION:
THE ACTIVE INGREDIENT AND
ITS QUANTITY:
Each hard capsule contains:
Lenvatinib (as mesilate) 4 mg
LENVIMA® 10 MG
HARD CAPSULES
COMPOSITION:
THE ACTIVE INGREDIENT AND
ITS QUANTITY:
Each hard capsule contains:
Lenvatinib (as mesilate) 10 mg
For list of excipients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about the medicine. If you have
any further questions, refer to the physician or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It may harm them, even if you think that
their illness is similar to yours.
This medicine is not intended for use in children and adolescents
under 18 years of age. The effects of LENVIMA in people younger than
18 years old are unknown.
Treatment with LENVIMA should be initiaited and supervised by a
physician experienced in the use of anticancer therapies.
1. WHAT IS THE MEDICINE INTENDED FOR?
-
For the treatment of advanced thyroid cancer in adults when
radioactive iodine treatment has not helped to stop the disease.
-
In combination with everolimus, for the treatment of advanced
clear cell kidney cancer in adults when other treatments [called
"targeted therapy VEGF (Vascular endothelial growth factor)”]
have not helped stop the disease.
-
As monotherapy for the treatment of liver cancer (hepatocellular
carcinoma) in adults who have not previously been treated with
systemic therapy with another anticancer medicine. People get
LENVIMA when their liver cancer has spread or cannot be taken
out by surgery.
-
In combination with pembrolizumab to treat advanced or
recurrent cancer of the lining of the uterus (endometrial carcinoma)
in adults whose cancer has spread while or after being previously
treated with

Αρχείο Π.Χ.Π.

1. NAME OF THE MEDICINAL PRODUCT
LENVIMA
® 4 MG
LENVIMA
® 10 MG
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LENVIMA
®
4 mg:
Each hard capsule contains 4 mg of lenvatinib (as mesylate).
LENVIMA
®
10 mg:
Each hard capsule contains 10 mg of lenvatinib (as mesylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
LENVIMA
®
4 mg:
A yellowish-red body and yellowish-red cap, approximately 14.3 mm in
length, marked in
black ink with
“Є” on the cap, and “LENV 4
mg” on the body.
Diameter 5.3mm, length 14.3
LENVIMA
®
10 mg:
A yellow body and yellowish-red cap, marked in black ink with
“Є” on the cap, and “LENV
10
mg” on the body.
Diameter 5.3mm, length 14.3,
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LENVIMA is indicated for the treatment of adult patients with
progressive, locally advanced
or metastatic, differentiated (papillary/follicular/Hürthle cell)
thyroid carcinoma (DTC),
refractory to radioactive iodine (RAI).
LENVIMA is indicated in combination with everolimus for the treatment
of adult patients
with advanced clear cell renal cell carcinoma (RCC) following one
prior vascular endothelial
growth factor (VEGF)-targeted therapy.
LENVIMA is indicated as monotherapy for the treatment of adult
patients with advanced or
unresectable hepatocellular carcinoma (HCC) who have received no prior
systemic therapy.
Lenvima, in combination with pembrolizumab, is indicated for the
treatment of adult patients
with advanced or recurrent endometrial carcinoma who have disease
progression on or
following prior treatment with a platinum containing therapy and who
are not candidates for
curative surgery or radiation.
LENVIMA is indicated in combination with pembrolizumab for the
first-line treatment of
adult patients with advanced RCC.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LENVIMA treatment should be initiated and supervised by a health care
professional
experienced in the use of anticancer therapies.
If a patient misses a dose, and it cannot be t