Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Ipilimumab
Bristol-Myers Squibb Pharma EEIG
L01XC11
ipilimumab
Antineoplastic agents
Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
MelanomaYERVOY as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).Renal cell carcinoma (RCC)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).Non-small cell lung cancer (NSCLC)YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.Malignant pleural mesothelioma (MPM)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
Revision: 53
Authorised
2011-07-13
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE USER YERVOY 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION ipilimumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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 YERVOY is and what it is used for 2. What you need to know before you use YERVOY 3. How to use YERVOY 4. Possible side effects 5. How to store YERVOY 6. Contents of the pack and other information 1. WHAT YERVOY IS AND WHAT IT IS USED FOR YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells. Ipilimumab alone is used to treat advanced melanoma (a type of skin cancer) in adults and adolescents 12 years of age and older. Ipilimumab in combination with nivolumab is used to treat advanced melanoma (a type of skin cancer) in adults and adolescents 12 years of age and older advanced renal cell carcinoma (advanced kidney cancer) in adults malignant pleural mesothelioma (a type of cancer that affects the lining of the lung) in adults advanced colorectal cancer (colon or rectal cancer) in adults advanced oesophageal cancer (gullet cancer) in adults. Ipilimumab in combination with nivolumab and chemotherapy is used to treat advanced non-small cell lung cancer (a type of lung cancer) in adult. As YERVOY may be given in combination with other anti-cancer medicines, it is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, please ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE YERVOY YOU SHOULD NOT BE GIVEN YERVOY if you are ALLERGIC to ipilimumab or any of the other ingredients of this medicine (listed in Sec Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 5 mg ipilimumab. One 10 ml vial contains 50 mg of ipilimumab. One 40 ml vial contains 200 mg of ipilimumab. Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) produced in Chinese hamster ovary cells by recombinant DNA technology. Excipients with known effect: Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non- small cell lung cancer (NSCLC) YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. 3 Malignant pleural mesothelioma (MPM) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Misma Прочетете целия документ