Xalkori 250mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Crizotinib

Διαθέσιμο από:

Pfizer Ltd

INN (Διεθνής Όνομα):

Crizotinib

Δοσολογία:

250mg

Φαρμακοτεχνική μορφή:

Capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08010500; GTIN: 5013457011623

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
XALKORI 200 MG HARD CAPSULES
XALKORI 250 MG HARD CAPSULES
Crizotinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1. What XALKORI_ _is and what it is used for
2. What you need to know before you take XALKORI
3. How to take XALKORI
4. Possible side effects
5. How to store XALKORI
6. Contents of the pack and other information
1.
WHAT XALKORI IS AND WHAT IT IS USED FOR
XALKORI_ _is an anticancer medicine containing the active substance
crizotinib used to treat adults
with a type of lung cancer called non-small cell lung cancer, that
presents with a specific
rearrangement or defect in either a gene called anaplastic lymphoma
kinase (ALK) or a gene called
ROS1.
XALKORI_ _can be prescribed to you for the initial treatment if your
disease is at an advanced stage of
lung cancer.
XALKORI_ _can be prescribed to you if your disease is at an advanced
stage and previous treatment has
not helped to stop your disease.
XALKORI_ _may slow or stop the growth of lung cancer. It may help
shrink tumours.
If you have any questions about how_ _XALKORI_ _works or why this
medicine has been prescribed for
you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XALKORI
DO NOT TAKE XALKORI

If you are allergic to crizoti

Αρχείο Π.Χ.Π.

OBJECT 1
XALKORI 200MG HARD CAPSULE
Summary of Product Characteristics Updated 20-Feb-2018 | Pfizer
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
XALKORI 200 mg hard capsules
XALKORI 250 mg hard capsules
2. Qualitative and quantitative composition
XALKORI 200 mg hard capsules
Each hard capsule contains 200 mg of crizotinib.
XALKORI 250 mg hard capsules
Each hard capsule contains 250 mg of crizotinib.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
XALKORI 200 mg hard capsules
White opaque and pink opaque hard capsule, with “Pfizer” imprinted
on the cap and “CRZ 200” on the
body.
XALKORI 250 mg hard capsules
Pink opaque hard capsule, with “Pfizer” imprinted on the cap and
“CRZ 250” on the body.
4. Clinical particulars
4.1 Therapeutic indications
XALKORI as monotherapy is indicated for:
• The first-line treatment of adults with anaplastic lymphoma kinase
(ALK)-positive advanced non-small
cell lung cancer (NSCLC)
• The treatment of adults with previously treated anaplastic
lymphoma kinase (ALK)-positive advanced
non-small cell lung cancer (NSCLC)
• The treatment of adults with ROS1-positive advanced non-small cell
lung cancer (NSCLC)
4.2 Posology and method of administration
Treatment with XALKORI should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
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 section 5.1 for information on assays used
in the trials).
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 specifi