Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
crizotinib
Pfizer Europe MA EEIG
L01ED01
crizotinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
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
Revision: 33
Authorised
2012-10-23
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 Przeczytaj cały dokument
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 Przeczytaj cały dokument