Xalkori 250 mg hard capsules

País: União Europeia

Língua: inglês

Origem: myHealthbox

Ingredientes ativos:

Crizotinib

Disponível em:

Pfizer Limited

Código ATC:

L01XE17

DCI (Denominação Comum Internacional):

Crizotinib

Dosagem:

250 mg

Forma farmacêutica:

Hard capsules

Via de administração:

Oral use

Unidades em pacote:

60

Tipo de prescrição:

Subject to medical prescription

Fabricado por:

Pfizer Manufacturing Deutschland GmbH

Grupo terapêutico:

Anti-neoplastic agents, protein kinase inhibitor

Área terapêutica:

Carcinoma, Non-Small-Cell Lung

Indicações terapêuticas:

Indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

Status de autorização:

Authorized

Data de autorização:

2012-10-24

Folheto informativo - Bula

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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 a gene called
anaplastic lymphoma kinase (ALK). 

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

Características técnicas

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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 250 mg hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each hard capsule contains 250 mg of crizotinib.  

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Hard capsule. 

Pink opaque hard capsule, with “Pfizer” imprinted on the cap
and “CRZ 250” on the body. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

XALKORI is indicated for the treatment of adults
with previously treated anaplastic lymphoma kinase 
(ALK)-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 testing 
_ _
An accurate and validated ALK assay is necessary for the
selection of patients for treatment with_ _
XALKORI (see section 5.1 for information on assays used in the
trials). 

ALK-positive NSCLC status should be established prior
to initiation of XALKORI therapy. 
Assessment should be performed by laboratories with demonstrated
proficiency in the specific 
technology being utilised (see section 4.4).  
_ _
Posology 

The recommended dose schedule of XALKORI is 250 mg twice
daily (500 mg daily) taken 
continuously.  

If a dose is missed, then it should be taken as soon as the
patient remembers unless it is less than 
6 hours until the next dose, in which case the patient should
not take the missed dose. Patients should 
not take 2 doses at the same time to make up for a missed dose. 

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_Dose adj