Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
capmatinib dihydrochloride monohydrate
Novartis Europharm Limited
L01EX17
capmatinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.
Revision: 1
Authorised
2022-06-20
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TABRECTA 150 MG FILM-COATED TABLETS TABRECTA 200 MG FILM-COATED TABLETS capmatinib 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 Tabrecta is and what it is used for 2. What you need to know before you take Tabrecta 3. How to take Tabrecta 4. Possible side effects 5. How to store Tabrecta 6. Contents of the pack and other information 1. WHAT TABRECTA IS AND WHAT IT IS USED FOR WHAT TABRECTA IS Tabrecta contains the active substance capmatinib, which belongs to a class of medicines called protein kinase inhibitors. WHAT TABRECTA IS USED FOR Tabrecta is a medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used if the lung cancer is advanced or has spread to other parts of the body (metastatic) and is caused by a change (mutation) in a gene that makes an enzyme called MET. Your tumour or blood will be tested for certain mutations in this gene. Your cancer is likely to respond to treatment with Tabrecta if the test result is positive. HOW TABRECTA WORKS Tabrecta helps to slow down or stop the growth and spread of your lung cancer if it is caused by a mutation in a gene that makes MET. If you have any questions about how Tabrecta works or Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Tabrecta 150 mg film-coated tablets Tabrecta 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tabrecta 150 mg film-coated tablets Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 150 mg capmatinib. Tabrecta 200 mg film-coated tablets Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 200 mg capmatinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Tabrecta 150 mg film-coated tablets Pale orange brown, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “DU” on one side and “NVR” on the other side. Approximate size: 18.3 mm (length) x 7.3 mm (width). Tabrecta 200 mg film-coated tablets Yellow, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “LO” on one side and “NVR” on the other side. Approximate size: 20.3 mm (length) x 8.1 mm (width). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Tabrecta should be initiated by a physician experienced in the use of anticancer therapies. Patients have to be selected for treatment with Tabrecta based on the presence of genetic alterations leading to a METex14 skipping mutation in tumour tissue or plasma specimens using a validated te Perskaitykite visą dokumentą