Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
avelumab
Merck Europe B.V.
L01FF04
avelumab
Other antineoplastic agents, Monoclonal antibodies
Neuroendocrine Tumors
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).Bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum‑based chemotherapy.
Revision: 16
Authorised
2017-09-18
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BAVENCIO 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION avelumab 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 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 Bavencio is and what it is used for 2. What you need to know before you use Bavencio 3. How to use Bavencio 4. Possible side effects 5. How to store Bavencio 6. Contents of the pack and other information 1. WHAT BAVENCIO IS AND WHAT IT IS USED FOR Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1. PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body’s natural defences). Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells. Bavencio is used in adults to treat: • Merkel cell carcinoma (MCC) , A RARE TYPE OF SKIN CANCER , when it is metastatic (has spread to other parts of the body). • Urothelial carcinoma (UC), A CANCER THAT ORIGINATES IN THE URINARY TRACT , when it is advanced or metastatic (has spread beyond the urinary bladder or to other parts of the body). Bavencio is used as maintenance treatment if the tumour has not grown after so called platinum-based chemotherapy as the first treatment. • Renal cell carcinoma (RCC) , A TYPE OF KIDNEY CANCER , when it is advanced (has spread beyond the kidney or to other parts of the body). For rena Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Bavencio 20 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg of avelumab. One vial of 10 mL contains 200 mg of avelumab. Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in 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, colourless to slightly yellow solution. The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 285 and 350 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the treatment of cancer. Posology The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks. Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity. The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenous Aqra d-dokument sħiħ