Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
lenvatinib mesylate
Eisai Europe Ltd
L01XE
lenvatinib
Antineoplastic agents
Thyroid Neoplasms
Lenvima is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Authorised
2015-05-28
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER LENVIMA 4 MG HARD CAPSULES LENVIMA 10 MG HARD CAPSULES lenvatinib 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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What LENVIMA is and what it is used for 2. What you need to know before you take LENVIMA 3. How to take LENVIMA 4. Possible side effects 5. How to store LENVIMA 6. Contents of the pack and other information 1. WHAT LENVIMA IS AND WHAT IT IS USED FOR WHAT LENVIMA IS LENVIMA is a medicine that contains the active substance lenvatinib. It is used to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease. HOW LENVIMA WORKS LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow. These proteins can be present in high amounts in cancer cells, and by blocking their action LENVIMA may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LENVIMA DO NOT TAKE LENVIMA IF: you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in sec Lestu allt skjalið
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 LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LENVIMA 4 mg hard capsules Each hard capsule contains 4 mg of lenvatinib (as mesilate). LENVIMA 10 mg hard capsules Each hard capsule contains 10 mg of lenvatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. LENVIMA 4 mg hard capsules A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body. LENVIMA 10 mg hard capsules A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies. Posology The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily. The daily dose is to be modified as needed according to the dose/toxicity management plan. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. 3 Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Optimal medical management (i.e. treatment or therapy) f Lestu allt skjalið