Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
AVELUMAB
MERCK SERONO LTD
CONCENTRATE FOR SOLUTION FOR INFUSION
AVELUMAB 20 MG / 1 ML
I.V
Required
MERCK SERONO S.A., SWITZERLAND
Metastatic Merkel Cell CarcinomaBavencio is indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).Locally Advanced or Metastatic Urothelial CarcinomaFirst-Line Maintenance Treatment of Urothelial CarcinomaBAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.Previously-Treated Urothelial CarcinomaBAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who:• Have disease progression during or following platinum-containing chemotherapy• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Advanced Renal Cell CarcinomaBAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
2022-12-31
Important safety information to minimise the risk of immune-related side effects (adverse reactions) PATIENT INFORMATION BROCHURE INFORMATION FOR PATIENTS This patient information brochure was approved by the Ministry of Health during June 2022. BAVENCIO ® (avelumab) 2 3 Introduction Your doctor has prescribed you BAVENCIO ® (avelumab) to treat your disease. This brochure will serve as a guide to your treatment, including what to expect while you are taking this medicine. This guide will explain some of the side effects that might occur while you undergo treatment with BAVENCIO ® and how to recognize them. You will also learn why it is important to report any symptoms to your doctor right away. About BAVENCIO ® (avelumab) BAVENCIO ® IS A MEDICINE USED TO TREAT SOME TYPES OF CANCER. BEFORE YOU START BAVENCIO ® Tell your doctor about any medications you are taking, have recently taken, or might take. Make sure your doctor knows if you: • Have an autoimmune disease (a condition where the body attacks its own cells) • Have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) • Have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) • Receive medicines to suppress your immune system • Have had an organ transplant • Are taking or have recently taken any other medicines • Are pregnant, think you may be pregnant, or are planning to have a baby • Could become pregnant. You must use effective contraceptives while you are being treated with BAVENCIO ® and for at least 1 month after your last dose • Are breast-feeding or plan to breast-feed. Do not breast feed while receiving BAVENCIO ® and for at least 1 month after your last dose Doctor Stamp Glue Alert Card Here 4 5 What you should know about your treatment HOW YOU RECEIVE BAVENCIO ® (AVELUMAB) BAVENCIO ® will be given to you in a hospital or clinic under the supervision of an experienced doctor. Your doctor will give you BAVENCIO ® through an infusion (a drip) Lue koko asiakirja
1 Prescribing Information BAVENCIO 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. Patient safety information booklet and card The marketing of Bavencio is subject to a risk management plan (RMP) including a 'Patient safety information booklet' and 'Patient card'. The 'Patient safety information booklet' and the 'Patient card', emphasize important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the booklet and the card before starting treatment. 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 Metastatic Merkel Cell Carcinoma Bavencio is indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Locally Advanced or Metastatic Urothelial Carcinoma _First-Line Maintenance Treatment of Urothelial Carcinoma _ Bavencio is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. 2 _Previously-Treated Urothelial Carcinoma _ Bavencio is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: - Have disease progression during or following platinum-containing chemotherapy - Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherap Lue koko asiakirja