Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Entrectinib
Roche Registration GmbH
L01EX14
entrectinib
Antineoplastic agents
Cancer; Carcinoma, Non-Small-Cell Lung
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior NTRK inhibitorwho have no satisfactory treatment options.Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Revision: 7
Authorised
2020-07-31
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROZLYTREK 100 MG HARD CAPSULES ROZLYTREK 200 MG HARD CAPSULES entrectinib 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 Rozlytrek is and what it is used for 2. What you need to know before you take Rozlytrek 3. How to take Rozlytrek 4. Possible side effects 5. How to store Rozlytrek 6. Contents of the pack and other information 1. WHAT ROZLYTREK IS AND WHAT IT IS USED FOR WHAT ROZLYTREK IS Rozlytrek is a cancer medicine that contains the active substance entrectinib. WHAT ROZLYTREK IS USED FOR Rozlytrek is used to treat either: • adults and children 12 years of age and older with solid tumour (cancer) in various parts of the body that is caused by a change in the neurotrophic tyrosine receptor kinase ( _NTRK_ ) gene, or • adults with a type of lung cancer called ‘non-small cell lung cancer’ (NSCLC) that is caused by a change in the _ROS1_ gene. _NTRK_ gene fusion-positive solid tumour cancer It is used when: • a test has shown that your cancer cells have a change in genes called ‘ _NTRK_ ’ and has spread within the affected organ or to other organs in your body or if surgery to remove the cancer is likely to result in severe complications (see ‘How Rozlytrek works Citiți documentul complet
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 Rozlytrek 100 mg hard capsules Rozlytrek 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rozlytrek 100 mg hard capsules Each hard capsule contains 100 mg of entrectinib. _Excipients with known effect _ Each hard capsule contains 65 mg lactose. Rozlytrek 200 mg hard capsules Each hard capsule contains 200 mg of entrectinib. _Excipients with known effect _ Each hard capsule contains 130 mg lactose, and 0.6 mg of the azo colouring agent sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Rozlytrek 100 mg hard capsules Size 2 (18 mm in length), hard capsule with yellow opaque body and cap with ENT 100 imprinted in blue on the body. Rozlytrek 200 mg hard capsules Size 0 (21.7 mm in length), hard capsule with orange opaque body and cap with ENT 200 imprinted in blue on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase ( _NTRK_ ) gene fusion, • who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and • who have not received a prior _NTRK_ inhibitor • who have no satisfactory treatment options (see sections 4.4 and 5.1). 3 Rozlytrek as monotherapy is indicated for the treatment of adult patients with _ROS1_ -positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Rozlytrek should be initiated by a physician experienced in the use of anticancer medi Citiți documentul complet