Xalkori 250mg Hard Capsules

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

Crizotinib

Tillgänglig från:

PFIZER (MALAYSIA) SDN. BHD.

INN (International namn):

Crizotinib

Enheter i paketet:

60capsule Capsules; 60capsule Capsules

Tillverkad av:

Pfizer Manufacturing Deutschland GmbH.

Bipacksedel

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
XALKORI
®
HARD CAPSULES
Crizotinib (200 mg, 250 mg)
WHAT IS IN THIS LEAFLET
1.
What XALKORI is used for
2.
How XALKORI works
3.
Before you use XALKORI
4.
How to use XALKORI
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
XALKORI
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT XALKORI IS USED FOR
XALKORI is a prescription medicine
that is used to treat people with non-
small cell lung cancer (NSCLC) that
is advanced or that has spread to other
parts of the body and is caused by a
defect in a gene called anaplastic
lymphoma kinase (ALK) or ROS1.
It is not known if XALKORI is safe
and effective in children.
HOW XALKORI WORKS
XALKORI is a class of medications
called protein kinase inhibitors. When
XALKORI block these kinases, it
prevents disruption that may happen
to a gene’s sequence. Any disruptions
in gene sequence can cause the
production of cancer-causing fusion
proteins. These cancer-causing fusion
proteins results in the dysregulation
of the gene function, which can cause
continued cell multiplication and
survival of cancer tumours.
XALKORI has shown effectiveness
in blocking these cancer-causing
proteins in various testing methods.
BEFORE YOU USE XALKORI
-
_When you must not use it _
Do not take XALKORI if you are
allergic (hypersensitive) to
crizotinib or any other ingredients
in XALKORI.
-
_Before you start to use it _
Tell your doctor if you:
▪
have liver heart or kidney
problems
▪
have any other medical
conditions
_Pregnancy and lactation _
Talk to your doctor if you are
pregnant, or plan to become pregnant
or think you may be pregnant.
XALKORI may cause reduced
fertility in males and females of
reproductive potential. However, it is
not known if this is reversible.
XALKORI may harm your unborn
baby. Your doctor will advise you of
the potential risk to your baby.
Women who are able to become
pregnant and men with partners who
may potentia

Produktens egenskaper

1
PFIZER
XALKORI
®
1
NAME OF THE MEDICINAL PRODUCT
XALKORI 200 MG HARD CAPSULES
XALKORI 250 MG HARD CAPSULES
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains either 200 mg or 250 mg of Crizotinib.
Crizotinib 200 mg hard capsule is a size 1, white opaque/pink opaque
hard gelatin capsule, containing a
white to pale yellow powder with CRZ 200 printed on the body in black
ink and Pfizer (logo) printed on
the cap in black ink.
Crizotinib 250 mg hard capsule is a size 0, pink opaque/pink opaque
hard gelatin capsule, containing a
white to pale yellow powder with CRZ 250 printed on the body in black
ink and Pfizer (logo) printed on
the cap in black ink.
3
PHARMACEUTICAL FORM
Hard gelatin capsules.
4
INDICATIONS AND USAGE
4.1
ALK- OR ROS1-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER
Crizotinib is indicated for the treatment of patients with advanced
non-small cell lung cancer (NSCLC)
whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive.
5
DOSAGE AND ADMINISTRATION
5.1
PATIENT SELECTION
Select patients for the treatment of metastatic NSCLC with XALKORI
based on the presence of ALK or
ROS1 positivity in tumor specimens _[_see _Clinical Studies (13.1,
13.2)]_.
5.2
ALK AND ROS1 TESTING
An accurate and validated assay for either ALK or ROS1 is necessary
for the selection of patients for
treatment with XALKORI _[_see_ Clinical Studies (13)]._
Either ALK-positive or ROS1-positive NSCLC status should be
established prior to initiation of Crizotinib
therapy.
Assessment should be performed by laboratories with demonstrated
proficiency in the specific technology
being utilized_ [_see_ Warnings and Precautions (7)]_.
2
5.3
RECOMMENDED DOSING FOR ALK- OR ROS1-POSITIVE METASTATIC NON SMALL CELL
LUNG CANCER
The recommended dose of XALKORI for patients with NSCLC is 250 mg
orally, twice daily, with or
without food, until disease progression or no longer tolerated by the
patient.
Swallow capsules whole. If a dose of XALKORI is missed, make up that
dose unless the next dose is due
within 6 hours. If vo