Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
durvalumab
AstraZeneca AB
L01XC28
durvalumab
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Non-Small Cell Lung Cancer (NSCLC)IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.Small Cell Lung Cancer (SCLC)IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).Biliary Tract Cancer (BTC)IMFINZI in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).Hepatocellular Carcinoma (HCC)IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
Revision: 18
Authorised
2018-09-21
55 B. PACKAGE LEAFLET 56 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMFINZI 50 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION durvalumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 IMFINZI is and what it is used for 2. What you need to know before you are given IMFINZI 3. How you are given IMFINZI 4. Possible side effects 5. How to store IMFINZI 6. Contents of the pack and other information 1. WHAT IMFINZI IS AND WHAT IT IS USED FOR IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. IMFINZI works by helping your immune system fight your cancer. IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults. It is used alone when your NSCLC: has spread within your lung and cannot be removed by surgery, and has responded or stabilised after initial treatment with chemotherapy and radiotherapy. It is used in combination with tremelimumab and chemotherapy when your NSCLC: has spread within both your lungs (and/or to other parts of the body), cannot be removed by surgery and has shown no changes (mutations) in genes called EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase). IMFINZI in combination with chemotherapy is used to treat a type of lung cancer called extensive- stage small cell lung cancer (ES-SCLC) in adults. It is used when your SCLC: has spread within your lungs (or to other parts of the body) and has not previously been treated. IMFINZI in combination with chemotherapy is used in adults to treat a type of cancer of the bile ducts (cholangiocarcinoma) and gallbladde Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IMFINZI 50 mg/ml concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 50 mg of durvalumab. One vial of 2.4 ml of concentrate contains 120 mg of durvalumab. One vial of 10 ml of concentrate contains 500 mg of durvalumab. Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to slightly yellow solution, free from visible particles. The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1). IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC) IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC) IMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC) IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated a Läs hela dokumentet