Lenvima 10mg Hard Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

lenvatinib mesilate

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

lenvatinib mesilate

Unit dalam pakej:

20capsule Capsules

Dikeluarkan oleh:

Eisai Co., Ltd.

Risalah maklumat

LENVIMA
® HARD CAPSULES
Lenvatinib (4mg, 10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What LENVIMA is used for
2.
How LENVIMA works
3.
Before you use LENVIMA
4.
How to use LENVIMA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LENVIMA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LENVIMA
IS USED FOR
LENVIMA is a medicine that contains
the active substance lenvatinib. It is
used to treat:

progressive or advanced thyroid
cancer in adults when radioactive
iodine treatment has not helped to
stop the disease.

patients with advanced kidney
cancer (advanced renal cell
carcinoma) as first treatment when
used in combination with
pembrolizumab.

patients with advanced kidney
cancer (advanced renal cell
carcinoma) where other treatments
(so-called “VEGF-targeted
therapy”) have not helped stop the
disease. It is used in combination
with everolimus.

liver cancer (
_hepatocellular _
_carcinoma_
) in adults who have not
previously been treated with another
anticancer medicine that travels
through the bloodstream. People get
LENVIMA when their liver cancer
has spread or cannot be taken out by
surgery.

Advanced cancer of the lining of the
uterus (endometrial carcinoma) in
patients whose cancer has spread
after being previously treated with
another anticancer medicine that
travels through the bloodstream and
cannot be taken out by surgery or
radiation treatment(a type of uterine
cancer) that is not microsatellite
instability-high (MSI-H) or
mismatch repair deficient (dMMR),
that has progressed after treatment
with anticancer medicine that
contained platinum and that cannot
be treated with surgery or radiation,
when used along together with
another anticancer medicine called
pembrolizumab.
HOW LENVIMA WORKS
LENVIMA blocks the action of
proteins called receptor tyrosine kinases
(RTKs), which are involved in the
development of new blood vessels that
supply oxygen and nutrients to cells
and help them

Ciri produk

1
LENVIMA
®
4 mg, 10 mg

1.
PRODUCT NAME
LENVIMA 4 mg hard capsules
LENVIMA 10 mg hard capsules
2.
PRODUCT DESCRIPTION AND COMPOSITION
LENVIMA 4 mg: Each hard capsule contains 4 mg of lenvatinib (as
mesilate).
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.
LENVIMA 10 mg: Each hard capsule contains 10 mg of lenvatinib (as
mesilate).
A yellow body and yellowish-red cap, approximately 14.3 mm in length,
marked in black ink with “Є” on the
cap, and “LENV 10 mg” on the body.
Excipients: Calcium carbonate, Mannitol, Microcrystalline cellulose,
Hydroxypropylcellulose, Low-
substituted hydroxypropylcellulose, Talc, Hypromellose, Titanium
dioxide (E171), Yellow iron oxide (E172),
Red iron oxide (E172), Shellac, Black iron oxide (E172), Potassium
hydroxide, Propylene glycol.
3.
INDICATION
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 in combination with pembrolizumab is indicated for the
first-line treatment of patients with
advanced renal cell carcinoma (RCC).
LENVIMA is indicated in combination with everolimus for the treatment
of adult patients with advanced 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 (see section 11.1)
LENVIMA, in combination with pembrolizumab, is indicated for the
treatment of adult patients with advanced
or recurrent endometrial carcinoma (EC) who have disease progression
on or following prior treatment with
platinum-containing therapy in any setting and are not candidates for
curative surgery or radiation.
4.
DOSAGE AND ADMINISTRATION
LENVIMA treatment