Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
lapatinib
Novartis Europharm Limited
L01EH01
lapatinib
Protein kinase inhibitors
Breast Neoplasms
Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2):in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting;in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy;in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Revision: 35
Authorised
2008-06-10
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER TYVERB 250 MG FILM-COATED TABLETS lapatinib 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. Don’t pass it on to others. It may harm them, even if their signs of illness seem 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 Tyverb is and what it is used for 2. What you need to know before you take Tyverb 3. How to take Tyverb 4. Possible side effects 5. How to store Tyverb 6. Contents of the pack and other information 1. WHAT TYVERB IS AND WHAT IT IS USED FOR TYVERB IS USED TO TREAT CERTAIN TYPES OF BREAST CANCER _(HER2-overexpressing)_ which have spread beyond the original tumour or to other organs ( _advanced_ or _metastatic_ breast cancer). It may slow or stop cancer cells from growing, or may kill them. Tyverb is prescribed to be taken in combination with another anti-cancer medicine. Tyverb is prescribed in COMBINATION WITH CAPECITABINE , for patients who have had treatment for advanced or metastatic breast cancer before. This previous treatment for metastatic breast cancer must have included trastuzumab. Tyverb is prescribed in COMBINATION WITH TRASTUZUMAB , for patients who have hormone receptor- negative metastatic breast cancer and have had other treatment for advanced or metastatic breast cancer before. Tyverb is prescribed in COMBINATION WITH AN AROMATASE INHIBITOR , for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy. Information about these medicines is described in separate patient information leaflets. ASK Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tyverb 250 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2); • in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1). • in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1). • in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone. HER2 status should be determined using accurate and validated methods. Posology _Tyverb / capecitabine combination posology _ The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously. The recommended dose Прочетете целия документ