Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
lenvatinib mesilate
Eisai GmbH
L01XE29
lenvatinib
Antineoplastic agents
Carcinoma, Renal Cell
Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):in combination with pembrolizumab, as first-line treatment (see section 5.1).in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Revision: 20
Authorised
2016-08-25
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER KISPLYX 4 MG HARD CAPSULES KISPLYX 10 MG HARD CAPSULES lenvatinib 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 Kisplyx is and what it is used for 2. What you need to know before you take Kisplyx 3. How to take Kisplyx 4. Possible side effects 5. How to store Kisplyx 6. Contents of the pack and other information 1. WHAT KISPLYX IS AND WHAT IT IS USED FOR WHAT KISPLYX IS Kisplyx is a medicine that contains the active substance lenvatinib. It is used in combination with pembrolizumab as the first treatment for adults with advanced kidney cancer (advanced renal cell carcinoma). It is also used in combination with everolimus to treat adults with advanced kidney cancer where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease. HOW KISPLYX WORKS Kisplyx 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 Kisplyx 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 KISPLYX DO NOT TAKE KISPLYX IF: • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6). • you are breast-feeding (se Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kisplyx 4 mg hard capsules Each hard capsule contains 4 mg of lenvatinib (as mesilate). Kisplyx 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. Kisplyx 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. Kisplyx 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 Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): • in combination with pembrolizumab, as first-line treatment (see section 5.1). • in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a healthcare professional experienced in the use of anticancer therapies. Posology _ _ _Kisplyx in combination with pembrolizumab as first-line treatment_ The recommended dose of lenvatinib is 20 mg (two 10-mg capsules) orally once daily in combination with pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The daily dose of lenvatinib is to be modified as needed according to the dose/toxicity management plan. Lenvatinib treatment should continue until disease 3 progression or unacceptable toxicity. Pembrolizumab should be continued until disease progression, unacceptable toxicity or the maximum duration of therapy as specified for pembrolizumab. See the Summary of Product Characteristics (SmPC) for pembrolizumab Przeczytaj cały dokument