Lenvima
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-05-2018
Charakterystyka produktu
(SPC)
18-05-2018
Sprawozdanie z oceny publicznego
(PAR)
25-06-2015
Składnik aktywny:
lenvatinib mesylate
Dostępny od:
Eisai Europe Ltd
Kod ATC:
L01XE
INN (International Nazwa):
lenvatinib
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Thyroid Neoplasms
Wskazania:
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).
Status autoryzacji:
Authorised
Data autoryzacji:
2015-05-28
Ulotka dla pacjenta
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
LENVIMA 4 MG HARD CAPSULES
LENVIMA 10 MG HARD CAPSULES
lenvatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What LENVIMA is and what it is used for
2.
What you need to know before you take LENVIMA
3.
How to take LENVIMA
4.
Possible side effects
5.
How to store LENVIMA
6.
Contents of the pack and other information
1.
WHAT LENVIMA IS AND WHAT IT IS USED FOR
WHAT LENVIMA IS
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.
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 to
grow. These proteins can be present in high amounts in cancer cells,
and by blocking their action
LENVIMA may slow the rate at which the cancer cells multiply and the
tumour grows and help to cut
off the blood supply that the cancer needs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LENVIMA
DO NOT TAKE LENVIMA IF:
you are allergic to lenvatinib or any of the other ingredients of this
medicine (listed in sec
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
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).
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.
Posology
The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules
and one 4 mg capsule) once
daily. The daily dose is to be modified as needed according to the
dose/toxicity management plan.
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.
3
Treatment should continue as long as clinical benefit is observed or
until unacceptable toxicity occurs.
Optimal medical management (i.e. treatment or therapy) f
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