País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
nintedanib
Boehringer Ingelheim International GmbH
L01XE3
nintedanib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.
Revision: 18
Authorised
2014-11-21
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VARGATEF 100 MG SOFT CAPSULES nintedanib 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vargatef is and what it is used for 2. What you need to know before you take Vargatef 3. How to take Vargatef 4. Possible side effects 5. How to store Vargatef 6. Contents of the pack and other information 1. WHAT VARGATEF IS AND WHAT IT IS USED FOR Vargatef capsules contain the active substance nintedanib. Nintedanib blocks the activity of a group of proteins which are involved in the development of new blood vessels that cancer cells need to supply them with food and oxygen. By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer. This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC). It is for adult patients whose NSCLC is of a certain type (“_adenocarcinoma_”) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARGATEF DO NOT TAKE VARGATEF - if you are allergic to nintedanib, to peanut or soya, or to any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine - if you have or had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung - if you Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg soft capsules Vargatef 150 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vargatef 100 mg soft capsules Each soft capsule contains 100 mg nintedanib (as esilate). _Excipients with known effect_ Each capsule contains 1.2 mg of soya lecithin. Vargatef 150 mg soft capsules Each soft capsule contains 150 mg nintedanib (as esilate). _Excipients with known effect_ Each capsule contains 1.8 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule (capsule). Vargatef 100 mg soft capsules Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”. Vargatef 150 mg soft capsules Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle. Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded. 3 Patients may continue therapy with nintedanib aft Llegiu el document complet