Tyverb

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

lapatinib

Saadav alates:

Novartis Europharm Limited

ATC kood:

L01EH01

INN (Rahvusvaheline Nimetus):

lapatinib

Terapeutiline rühm:

Protein kinase inhibitors

Terapeutiline ala:

Breast Neoplasms

Näidustused:

Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2):in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting;in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy;in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

Toote kokkuvõte:

Revision: 35

Volitamisolek:

Authorised

Loa andmise kuupäev:

2008-06-10

Infovoldik

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVERB 250 MG FILM-COATED TABLETS
lapatinib
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. Don’t pass it on to
others. It may harm them,
even if their signs of illness seem the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tyverb is and what it is used for
2.
What you need to know before you take Tyverb
3.
How to take Tyverb
4.
Possible side effects
5.
How to store Tyverb
6.
Contents of the pack and other information
1.
WHAT TYVERB IS AND WHAT IT IS USED FOR
TYVERB IS USED TO TREAT CERTAIN TYPES OF BREAST CANCER
_(HER2-overexpressing)_
which have spread
beyond the original tumour or to other organs (
_advanced_
or
_metastatic_
breast cancer). It may slow or
stop cancer cells from growing, or may kill them.
Tyverb is prescribed to be taken in combination with another
anti-cancer medicine.
Tyverb is prescribed in
COMBINATION WITH CAPECITABINE
, for patients who have had treatment for
advanced or metastatic breast cancer before. This previous treatment
for metastatic breast cancer must
have included trastuzumab.
Tyverb is prescribed in
COMBINATION WITH TRASTUZUMAB
, for patients who have hormone receptor-
negative metastatic breast cancer and have had other treatment for
advanced or metastatic breast
cancer
before.
Tyverb is prescribed in
COMBINATION WITH AN AROMATASE INHIBITOR
, for patients with hormone
sensitive metastatic breast cancer (breast cancer that is more likely
to grow in the presence of
hormones), who are not currently intended for chemotherapy.
Information about these medicines is described in separate patient
information leaflets.
ASK

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tyverb 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lapatinib ditosylate monohydrate,
equivalent to 250 mg lapatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tyverb is indicated for the treatment of adult patients with breast
cancer, whose tumours overexpress
HER2 (ErbB2);
•
in combination with capecitabine for patients with advanced or
metastatic disease with
progression following prior therapy, which must have included
anthracyclines and taxanes and
therapy with trastuzumab in the metastatic setting (see section 5.1).
•
in combination with trastuzumab for patients with hormone
receptor-negative metastatic disease
that has progressed on prior trastuzumab therapy(ies) in combination
with chemotherapy (see
section 5.1).
•
in combination with an aromatase inhibitor for postmenopausal women
with hormone receptor
positive metastatic disease, not currently intended for chemotherapy.
The patients in the
registration study were not previously treated with trastuzumab or an
aromatase inhibitor (see
sections 4.4. and 5.1). No data are available on the efficacy of this
combination relative to
trastuzumab in combination with an aromatase inhibitor in this patient
population.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tyverb treatment should only be initiated by a physician experienced
in the administration of
anti-cancer medicinal products.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+
with gene amplification or
gene amplification alone. HER2 status should be determined using
accurate and validated methods.
Posology
_Tyverb / capecitabine combination posology _
The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once
daily continuously.
The recommended dose