Xalkori

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

crizotinib

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

L01ED01

INN (Kansainvälinen yleisnimi):

crizotinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Non-Small-Cell Lung

Käyttöaiheet:

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)The treatment of paediatric patients (age ≥6 to

Tuoteyhteenveto:

Revision: 33

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-10-23

Pakkausseloste

55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET: INFORMATION FOR THE USER
XALKORI 200 MG HARD CAPSULES
XALKORI 250 MG HARD CAPSULES
crizotinib
THE WORDS “YOU” AND “YOUR” ARE USED TO REFER TO BOTH THE ADULT
PATIENT AND TO THE CAREGIVER OF
THE PAEDIATRIC PATIENT.
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
.
XALKORI is used to treat children and adolescents (age ≥6 to <18
years) with a type of tumour called
anaplastic large cell lymphoma (ALCL) or a type of tumour called
inflammatory myofibroblastic
tumour (IMT) that present with a specific rearrangement or defect in a
gene called anaplastic
lymphoma kinase (ALK).
XALKORI can

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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)

The treatment of paediatric patients (age ≥6 to <18 years) with
relapsed or refractory systemic
anaplastic lymphoma kinase (ALK)-positive anaplastic large cell
lymphoma (ALCL)

The treatment of paediatric patients (age ≥6 to <18 years) with
recurrent or refractory
anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory
myofibroblastic
tumour (IMT)
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.
3
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 clinical studies).
ALK-positive NSCLC, ROS1-positive NSCLC, ALK-positive ALCL or
ALK-positive IMT status
should be established prior to initiation of criz