Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cabozantinib s-malate
Ipsen Ltd
L01XE26
Cabozantinib s-malate
40mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 3582186003831
Page 1 of 8 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 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. 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 to treat advanced stages of a type of kidney cancer called renal cell carcinoma in adults. 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 cancer cells, and by blocking their action CABOMETYX can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABOMETYX DO NOT TAKE CABOMETYX - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk Aqra d-dokument sħiħ
OBJECT 1 CABOMETYX 20MG Summary of Product Characteristics Updated 18-May-2018 | Ipsen Ltd 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 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. 4. Clinical particulars 4.1 Therapeutic indications CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-t Aqra d-dokument sħiħ