Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
cabozantinib (s)-malate
Ipsen Pharma
L01EX07
cabozantinib
Antineoplastic agents
Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Renal Cell Carcinoma (RCC)Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.Hepatocellular Carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Revision: 18
Authorised
2016-09-09
54 B. PACKAGE LEAFLET 55 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CABOMETYX 20 MG FILM-COATED TABLETS CABOMETYX 40 MG FILM-COATED TABLETS CABOMETYX 60 MG FILM-COATED TABLETS cabozantinib 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CABOMETYX is and what it is used for 2. What you need to know before you take CABOMETYX 3. How to take CABOMETYX 4. Possible side effects 5. How to store CABOMETYX 6. Contents of the pack and other information 1. WHAT CABOMETYX IS AND WHAT IT IS USED FOR WHAT CABOMETYX IS CABOMETYX is a cancer medicine that contains the active substance cabozantinib. It is used in adults to treat: - advanced kidney cancer called advanced renal cell carcinoma - liver cancer when a specific anticancer medicine (sorafenib) is no longer stopping the disease from progressing. CABOMETYX is also used to treat locally advanced or metastatic differentiated thyroid cancer, a type of cancer in the thyroid gland, in adults when radioactive iodine and anticancer medicine treatments are no longer stopping the disease from progressing. CABOMETYX may be given in combination with nivolumab for advanced kidney cancer. It is important that you also read the package leaflet of nivolumab. If you have any questions about these medicines, please ask your doctor. HOW CABOMETYX WORKS CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. These proteins can be present in high amounts in cance Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 15.54 mg lactose. CABOMETYX 40 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 31.07 mg lactose. CABOMETYX 60 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib. _Excipients with known effect _ Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. CABOMETYX 20 mg film-coated tablets The tablets are yellow round with no score and debossed with “XL” on one side and “20” on the other side of the tablet. CABOMETYX 40 mg film-coated tablets The tablets are yellow triangle shaped with no score and debossed with “XL” on one side and “40” on the other side of the tablet. CABOMETYX 60 mg film-coated tablets The tablets are yellow oval shaped with no score and debossed with “XL” on one side and “60” on the other side of the tablet. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renal cell carcinoma (RCC) CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma - as first-line treatment of adult patients with intermediate or poor risk (see section 5.1), - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). Hepatocellular carcinoma (HCC) CABOMETYX is indicated as monotherapy for the treatment Прочетете целия документ