Brastib 250 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LAPATINIBDITOSILAAT 1-WATER 405 mg/stuk SAMENSTELLING overeenkomend met ; LAPATINIB 250 mg/stuk

INN (Algemene Internationale Benaming):

LAPATINIBDITOSILAAT 1-WATER 405 mg/stuk SAMENSTELLING overeenkomend met ; LAPATINIB 250 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRASTIB 250 MG, FILMOMHULDE TABLETTEN
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 Brastib is and what it is used for
2.
What you need to know before you take Brastib
3.
How to take Brastib
4.
Possible side effects
5.
How to store Brastib
6.
Contents of the pack and other information
1.
WHAT BRASTIB IS AND WHAT IT IS USED FOR
Brastib 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.
Brastib is prescribed to be taken in combination with another
anti-cancer medicine.
Brastib 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.
Brastib 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.
Brastib 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 YOUR
DOCTOR to

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brastib 250 mg, filmomhulde tabletten
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, off-white film-coated tablets debossed with “250”
on one side and plain on the
other, with dimensions of 16.6 mm x 8.3 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brastib 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
Brastib 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
_Brastib / capecitabine combination posology _
_ _
The recommended dose of Brastib is 1250 mg