Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Daratumumab
Janssen-Cilag International N.V.
L01FC01
daratumumab
monoclonal antibodies and antibody drug conjugates, Antineoplastic agents
Multiple Myeloma
Multiple MyelomaDarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.AL AmyloidosisDARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
Revision: 21
Authorised
2016-05-20
85 B. PACKAGE LEAFLET 86 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION daratumumab 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DARZALEX is and what it is used for 2. What you need to know before you are given DARZALEX 3. How DARZALEX is given 4. Possible side effects 5. How to store DARZALEX 6. Contents of the pack and other information 1. WHAT DARZALEX IS AND WHAT IT IS USED FOR WHAT DARZALEX IS DARZALEX is a cancer medicine that contains the active substance daratumumab. It belongs to a group of medicines called “monoclonal antibodies”. Monoclonal antibodies are proteins that have been designed to recognise and attach to specific targets in the body. Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells. WHAT DARZALEX IS USED FOR DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”. This is a cancer of your bone marrow. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DARZALEX YOU MUST NOT BE GIVEN DARZALEX - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6). Do not use DARZALEX if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given DARZALEX. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given DARZALEX. Infusion-related reactions DARZALEX is given as an infusion (drip) into a vein. Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during tre Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DARZALEX 20 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL). Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL). Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary) using recombinant DNA technology. Excipient with known effect Each 5 mL vial of solution for infusion contains 273.3 mg of sorbitol (E420). Each 20 mL vial of solution for infusion contains 1093 mg of sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The solution is colourless to yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DARZALEX is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Pre- and post-infusion medicinal products should be administered to reduce the risk of infusion-related reacti Przeczytaj cały dokument