LENVIMA

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

LENVATINIB MESILATE

MAH:

EISAI INDONESIA - Indonesia

INN:

LENVATINIB MESILATE

dosage:

10 MG

pharmaceutical_form:

KAPSUL

units_in_package:

DUS, 2 BLISTER @ 10 KAPSUL

manufactured_by:

EISAI INDONESIA - Indonesia

authorization_date:

2018-07-17

SPC

PT Eisai Indonesia | Product Information LENVIMA
1
1.
NAME OF THE MEDICINAL PRODUCT
LENVIMA 4 mg hard capsules
LENVIMA 10 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LENVIMA 4 mg hard capsules
Each hard capsule contains 4 mg of lenvatinib (as mesilate).
LENVIMA 10 mg hard capsules
Each hard capsule contains 10 mg of lenvatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
LENVIMA 4 mg hard capsules
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 hard capsules
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.
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 as monotherapy for the treatment of adult
patients with advanced or
unresectable hepatocellular carcinoma (HCC) who have received no prior
systemic therapy (see
section 5.1).
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 taken within 12 hours,
then that dose should be skipped
and the next dose should be taken at the usual time of administration.
Disetujui oleh Badan POM: 12/11/2019 EREG17180811900025
EREG17180811900026
PT Eisai Indonesia | Product Information LENVIMA
2
Treatment should continue as long as clinical benefit is observed or
until unacceptable toxicity
occurs.
Optimal medical management (i.e. treatment or therapy) for nausea,
vomiting, and diarrhoea
should be initiated prior to any lenvatinib therapy interruption or
dose reduction; gastrointestinal