Zykadia 150mg Hard Capsules

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

Ceritinib

Tilgjengelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

Ceritinib

Enheter i pakken:

150 Capsules; 50 Capsules

Produsert av:

NOVARTIS PHARMA STEIN A.G.

Informasjon til brukeren

_Customer Medication Indication Leaflet (RiMUP) _
ZYKADIA® HARD CAPSULES
Ceritinib (150mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT ZYKADIA IS USED FOR
2.
HOW ZYKADIA WORKS
3.
BEFORE YOU USE ZYKADIA
4.
HOW TO USE ZYKADIA
5.
WHILE YOU ARE USING
ZYKADIA
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
ZYKADIA
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT ZYKADIA IS USED FOR
ZYKADIA is a cancer medicine
that
contains
active
substance
ceritinib. It is used to treat adults
with advanced stages of a form of
lung cancer called non-small cell
lung cancer (NSCLC). Zykadia is
only
given
to
patients
whose
disease is due to a defect in a gene
called
ALK
(anaplastic
lymphoma kinase).
HOW ZYKADIA WORKS
Zykadia
belongs
to
a
group
of
anti-tumour medicines which stop
cancer from making new cells if
the cancer is caused by a defect in
a gene called ALK (i.e., “ALK-
positive”).
Zykadia
slows
down
the growth and spread of NSCLC
which is ALK-positive.
If you have any questions about
how Zykadia works or why this
medicine has been prescribed for
you, ask your doctor.
BEFORE YOU USE ZYKADIA
Follow
all
the
doctor’s
instructions carefully. They may
differ
from
the
general
information
contained
in
this
leaflet.
_When you must not use it _
-
if you are pregnant or breast-
feeding.
If the above applies to you, tell
your doctor who will then decide
whether
you
should
start
treatment with Zykadia.
_PREGNANCY AND BREAST-FEEDING _
Zykadia
is
not
recommended
during
pregnancy
unless
the
potential
benefit
outweighs
the
potential risk to the fetus. If you
are pregnant, think you might be
pregnant
or
plan
to
become
pregnant,
ask
your
doctor
for
advice. Your doctor will discuss
with
you
the
potential
risks
of
taking Zykadia during pregnancy.
Zykadia
should
not
be
used
during
breast
feeding.
You
and
your doctor will decide together
whether you should breast-feed or
take Zykadia. You should not do
both.
_Before you start to use it _
Before you take ZYKADIA, tell
your healthcare provider about all
of
your
med

Preparatomtale

Novartis
Page 2
Malaysia Package Leaflet
5 Jan 2021
Zykadia®
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
Zykadia as monotherapy is indicated for the first-line treatment of
adult patients with anaplastic lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC).
ZYKADIA as monotherapy is indicated for the treatment of adult
patients with anaplastic lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC) previously
treated with crizotinib.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for treatment of metastatic NSCLC with ZYKADIA based
on the presence of ALK positivity in tumor
specimens
_[see Clinical Studies (14.1)]_
.
2.2
RECOMMENDED DOSAGE
The recommended dosage of ZYKADIA is 450 mg orally once daily with
food until disease progression or unacceptable
toxicity
_[see Clinical Pharmacology (12.3)]_
.
If a dose of ZYKADIA is missed, make up that dose unless the next dose
is due within 12 hours.
If vomiting occurs during the course of treatment, do not administer
an additional dose and continue with the next
scheduled dose of ZYKADIA.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
TABLE 1: RECOMMENDED ZYKADIA DOSE REDUCTIONS
DOSE REDUCTION
RECOMMENDED DOSAGE
First-dose reduction
300 mg taken orally once daily with food
Second-dose reduction
150 mg taken orally once daily with food
Discontinue ZYKADIA for patients unable to tolerate 150 mg taken
orally once daily with food.
Dosage modifications for selected adverse reactions of ZYKADIA are
provided in Table 2. If dose reduction is required
due to an adverse reaction not listed in Table 2, then reduce the
daily dose of ZYKADIA by 150 mg.
TABLE 2: RECOMMENDED ZYKADIA DOSAGE MODIFICATIONS FOR ADVERSE
REACTIONS
ADVERSE REACTION
ZYKADIA DOSE MODIFICATION
GASTROINTESTINAL ADVERSE REACTIONS _[see Warnings and Precautions
(5.1)]_
Severe or intolerable nausea, vomiting, or diarrhea despite
optimal antiemetic or anti-diarrheal therapy
Withhold until improved, then resume ZYKADIA at the next
lower dosage.
HE