TYKERB FILM-COATED TABLETS 250MG

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

LAPATINIB DITOSYLATE

Pieejams no:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

LAPATINIB DITOSYLATE

Vienības iepakojumā:

70 Tablets

Ražojis:

S.C. Sandoz S.R.L.

Lietošanas instrukcija

_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
11.
Serial number
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 of cancer 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, te

Produkta apraksts

Novartis
Page 2
Malaysia Package Leaflet
18 Aug 2021
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 (12.3)]_
.
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 TYK