Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Selpercatinib
Eli Lilly Nederland B.V.
L01EX22
selpercatinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitoradvanced RET fusion-positive thyroid cancer who require systematic therapy following prior treatment
Revision: 8
Authorised
2021-02-11
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RETSEVMO 40 MG HARD CAPSULES RETSEVMO 80 MG HARD CAPSULES selpercatinib 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. - This leaflet has been written as though the person taking the medicine is reading it. If you are giving this medicine to your child, please replace “you” with “your child” throughout. WHAT IS IN THIS LEAFLET 1. What Retsevmo is and what it is used for 2. What you need to know before you take Retsevmo 3. How to take Retsevmo 4. Possible side effects 5. How to store Retsevmo 6. Contents of the pack and other information 1. WHAT RETSEVMO IS AND WHAT IT IS USED FOR Retsevmo is an anticancer medicine containing the active substance selpercatinib. It is used to treat the following cancers which are caused by certain abnormal changes in the RET gene and which have spread and/or cannot be removed by surgery: - A type of lung cancer called non-small cell lung cancer, in adults who have not previously been treated with a _RET _ inhibitor medicine. - Thyroid cancer (any type) in adults and adolescents 12 years and older if radioactive iodine treatment, when appropriate, has failed to control your cancer. - A rare type of thyroid cancer called medullary thyroid cancer in adults and adolescents 12 years an 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 Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Retsevmo 40 mg hard capsules Each hard capsule contains 40 mg selpercatinib. Retsevmo 80 mg hard capsules Each hard capsule contains 80 mg selpercatinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. Retsevmo 40 mg hard capsules Grey opaque capsule, 6 x 18 mm (size 2), imprinted with “Lilly”, “3977” and “40 mg” in black ink. Retsevmo 80 mg hard capsules Blue opaque capsule, 8 x 22 mm (size 0), imprinted with “Lilly”, “2980” and “80 mg” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Retsevmo as monotherapy is indicated for the treatment of adults with: – advanced _RET_ fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a _RET_ inhibitor Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with: – advanced _RET_ fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) – advanced _RET_ -mutant medullary thyroid cancer (MTC) 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Retsevmo therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies. RET testing The presence of a _RET _ gene fusion (NSCLC and non-medullary thyroid cancer) or mutation (MTC) should be confirmed by a validated test prior to initiation of treatment with Retsevmo. Posology The recommended dose of Retsevmo based on body weight is: - Less than 50 kg: 120 mg twice daily. - 50 kg or greater: 160 mg twice daily. If a patient vomits or misses a dose, the patient should be Citiți documentul complet