TYKERB FILM-COATED TABLETS 250MG

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

LAPATINIB DITOSYLATE

Disponible des:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

Designació comuna internacional (DCI):

LAPATINIB DITOSYLATE

Unidades en paquete:

70 Tablet Tablets; 84 Tablet Tablets

Fabricat per:

GLAXO OPERATIONS UK LTD

Informació per a l'usuari

_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TYKERB
® FILM-COATED TABLET
Lapatinib ditosylate (250mg)
1
WHAT IS IN THIS LEAFLET
1.
What Tykerb is used for
2.
How Tykerb works
3.
Before you use Tykerb
4.
How to use Tykerb
5.
While you are using Tykerb
6.
Side Effects
7.
Storage and Disposal of
Tykerb
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT TYKERB IS USED FOR
Tykerb is a prescription medicine
used:
•
with the medicine
capecitabine to treat people
with breast cancer that is
advanced or that has spread
to other parts of the body
(metastatic), and.
o
that is HER2-positive
(tumors that produce
large amounts of a
protein called human
epidermal growth factor
receptor-2),
AND
o
who have already had
certain other breast
cancer treatments
Before taking Tykerb with
capecitabine, your breast
cancer should have gotten
worse (progressed) with the
medicine trastuzumab.
•
with the medicine letrozole to
treat women who:
o
have gone through the
change of life
(postmenopausal), and
o
who have metastatic
breast cancer that is
hormone receptor-
positive, HER2-positive,
and hormonal therapy is
a treatment option for
them.
HOW TYKERB WORKS
Tykerb belongs to a group of
medicines known as protein
kinase inhibitors. It is used to
treat certain types of breast
cancer. Breast cancer is caused by
cells that divide abnormally in the
breast. These cells may reach
other tissues of the body at a later
stage in a process called
metastasis. It may slow the
growth ofcancer cells or may kill
them.
BEFORE YOU USE TYKERB
_-When you must not use it _
Do not take Tykerb if you are
allergic to Lapatinib or any of the
ingredients in Tykerb. A complete
list of ingredients in Tykerb can
be found at the end of this
Customer Medication Information
Leaflet.
_- Before you start to use it _
Before you take Tykerb, tell your
doctor if you:
•
have heart problems.
•
have liver problems. You
may need a lower dose of
Tykerb.
•
have any other medical
conditions.
For females, tell your healthcare

Fitxa tècnica

Novartis
Page 2
Malaysia Package Leaflet
27 Aug 2018
Tykerb
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
TYKERB is indicated in combination with:
•
capecitabine for the treatment of patients with advanced or metastatic
breast cancer
whose tumors overexpress HER2 and who have received prior therapy
including an
anthracycline, a taxane, and trastuzumab.
Limitations of Use: Patients should have disease progression on
trastuzumab prior to
initiation of treatment with TYKERB in combination with capecitabine.
•
letrozole for the treatment of postmenopausal women with hormone
receptor-positive
metastatic breast cancer that overexpresses the HER2 receptor for whom
hormonal
therapy is indicated.
TYKERB in combination with an aromatase inhibitor has not been
compared to a
trastuzumab-containing chemotherapy regimen for the treatment of
metastatic breast cancer.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSING
HER2-Positive Metastatic Breast Cancer: The recommended dose of TYKERB
is 1,250
mg given orally once daily on Days 1-21 continuously in combination
with capecitabine 2,000
mg/m
2
/day (administered orally in 2 doses approximately 12 hours apart) on
Days 1-14 in a
repeating 21-day cycle. TYKERB should be taken at least one hour
before or one hour after a meal.
The dose of TYKERB should be once daily (5 tablets administered all at
once); dividing the daily
dose is not recommended [
_see Clinical Pharmacology (11)_
]. Capecitabine should be taken with
food or within 30 minutes after food. If a day’s dose is missed, the
patient should not double the
dose the next day. Treatment should be continued until disease
progression or unacceptable
toxicity occurs.
Hormone Receptor-Positive, HER2-Positive Metastatic Breast Cancer: The
recommended
dose of TYKERB is 1,500 mg given orally once daily continuously in
combination with letrozole.
When coadministered with TYKERB, the recommended dose of letrozole is
2.5 mg once daily.
TYKERB should be taken at least one hour before or one hour after a
meal. The dose of TYKE