Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
sorafenib
Bayer AG
L01EX02
sorafenib
Antineoplastic agents
Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Hepatocellular carcinomaNexavar is indicated for the treatment of hepatocellular carcinoma.Renal cell carcinomaNexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.Differentiated thyroid carcinomaNexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Revision: 33
Authorised
2006-07-19
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER NEXAVAR 200 MG FILM-COATED TABLETS sorafenib 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nexavar is and what it is used for 2. What you need to know before you take Nexavar 3. How to take Nexavar 4. Possible side effects 5. How to store Nexavar 6. Contents of the pack and other information 1. WHAT NEXAVAR IS AND WHAT IT IS USED FOR Nexavar is used to treat liver cancer ( _hepatocellular carcinoma_ ). Nexavar is also used to treat kidney cancer ( _advanced renal cell carcinoma_ ) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable. Nexavar is used to treat thyroid cancer ( _differentiated thyroid carcinoma_ ). Nexavar is a so-called _multikinase inhibitor. _ It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing. 2. WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE NEXAVAR DO NOT TAKE NEXAVAR - IF YOU ARE ALLERGIC to sorafenib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Nexavar. TAKE SPECIAL CARE WITH NEXAVAR - IF YOU EXPERIENCE SKIN PROBLEMS. Nexavar can cause rashes and skin reactions, especially on the hands and feet. These can usually be treated by your doctor. If not, your doctor may interrupt treatment or stop it altogether. - IF YOU HAVE HIGH BLOOD PRESSURE. Nexavar can raise blood pressure, and your doctor Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nexavar 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of sorafenib (as tosylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Red, round, faceted biconvex film-coated tablet, with Bayer cross on one side and "200" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg). Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Posology adjustments Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy. When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4). 3 When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the Nexavar dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tabl Przeczytaj cały dokument