Lapatinib PharOS 250 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC code:

L01EH01

INN (International Name):

LAPATINIB 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LAPATINIB 250 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-07-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LAPATINIB PHAROS
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 Lapatinib PharOS is and what it is used for
2.
What you need to know before you take Lapatinib PharOS
3.
How to take Lapatinib PharOS
4.
Possible side effects
5.
How to store Lapatinib PharOS
6.
Contents of the pack and other information
1.
WHAT LAPATINIB PHAROS IS AND WHAT IT IS USED FOR
Lapatinib PharOS 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.
Lapatinib PharOS is prescribed to be taken in combination with another
anti-cancer
medicine.
Lapatinib PharOS 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.
Lapatinib PharOS 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.
Lapatinib PharOS 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
chemoth

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lapatinib PharOS 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, 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
Lapatinib PharOS 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
Lapatinib PharOS 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
_Lapatinib PharOS / capecitabine combination posology _
Pa