NERLYNX (neratinib) Film-Coated Tablets 40 mg

Country: Malaysia

Language: English

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

Active ingredient:

Neratinib Maleate

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Neratinib Maleate

Units in package:

180 Tablets

Manufactured by:

Excella GmbH & Co.KG

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
NERLYNX
® FILM-COATED TABLETS
_Neratinib (40mg) _
_ _
_ _ WHAT IS IN THIS LEAFLET
1.
What Nerlynx is used for
2.
How Nerlynx works
3.
Before you use Nerlynx
4.
How to use Nerlynx
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Nerlynx
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
This leaflet answers some common
questions about Nerlynx Tablets.
It does not contain all the available
information.
It
does
not
take
the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
Nerlynx
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may want to read it again.
1.
WHAT NERLYNX IS USED FOR
Nerlynx
contains
the
active
substance
neratinib.
Neratinib
belongs
to
a
group
of
medicines
called
‘tyrosine
kinase
inhibitors’
used to block cancer cells and treat
breast cancer.
Nerlynx is used for women who
have
early
stage
breast
cancer
which:
-
is human epidermal growth factor
receptor
2-positive
(HER2-
positive) and
-
has previously been treated with
another
medicine
called
‘trastuzumab’
-
NERLYNX is also used with a
medicine called capecitabine to
treat adults with HER2-positive
breast cancer that has spread to
other
parts
of
the
body
(metastatic)
and
who
have
received 2 or more anti-HER2
therapy
medicines
for
metastatic breast cancer.
The ‘HER2 receptor’ is a protein
found on the surface of cells in the
body.
It
helps
control
how
a
healthy
breast
cell
grows.
In
HER2-positive breast cancer, the
cancer cells have a large amount of
HER2
receptors
on
their
surface.
This
results
in
the
cancer
cells
dividing and growing faster.
Before
Nerlynx
is
used,
your
cancer must have been tested to
show
it
is
HER2-positive.
You
must
also
have
previously
been
treated with trastuzumab.
2.
HOW NERLYNX WORKS
Nerlynx

Summary of Product characteristics

NERLYNX
® (NERATINIB) FILM-COATED TABLETS 40 MG
1
INDICATIONS AND USAGE
1.1
EXTENDED ADJUVANT TREATMENT OF EARLY-STAGE BREAST CANCER
NERLYNX is indicated for the extended adjuvant treatment of women with
early-stage hormone
receptor positive HER2-overexpressed/amplified breast cancer and who
completed adjuvant
trastuzumab-based therapy less than one year ago [see
_Clinical Studies (13.1)_
].
1.2
ADVANCED OR METASTATIC BREAST CANCER
NERLYNX in combination with capecitabine is indicated for the
treatment of adult patients with
advanced or metastatic HER2-positive breast cancer who have received
two or more prior anti-
HER2 based regimens in the metastatic setting [see
_Clinical Studies (13.2)_
].
2
DOSAGE AND ADMINISTRATION
2.1
PREMEDICATION FOR DIARRHEA
When not using dose escalation
_[see Dosage and Administration (2.2)],_
administer antidiarrheal prophylaxis during
the first 56 days of treatment and initiate with the first dose of
NERLYNX
_[see Warnings and Precautions (5.1) and _
_Adverse Reactions (6.1)]._
Instruct patients to take loperamide as directed in Table 1. Titrate
loperamide to 1-2 bowel movements per
day.
TABLE 1:
LOPERAMIDE PROPHYLAXIS
TIME ON NERLYNX
LOPERAMIDE DOSE AND FREQUENCY
Weeks 1-2 (days 1 - 14)
4 mg three times daily
Weeks 3-8 (days 15 - 56)
4 mg twice daily
Weeks 9-Discontinuation of
NERLYNX
4 mg as needed, not to exceed 16 mg
per day; titrate dosing to achieve 1-2
bowel movements per day
If diarrhea occurs despite prophylaxis, treat with additional
antidiarrheals, fluids and electrolytes
as clinically indicated. NERLYNX dose interruptions and dose
reductions may also be required to
manage diarrhea [
_see Dosage and Administration (2.3)_
].
2.2
RECOMMENDED DOSE AND SCHEDULE
_EXTENDED ADJUVANT TREATMENT OF EARLY-STAGE BREAST CANCER _
The recommended dose of NERLYNX is 240 mg (six tablets) given orally
once daily with food,
continuously until disease recurrence or for up to one year.
_ADVANCED OR METASTATIC BREAST CANCER _
The recommended dose of NERLYNX is 240 mg (six tablets) given oral