Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
belantamab mafodotin
GlaxoSmithKline (Ireland) Limited
L01XC39
belantamab mafodotin
Antineoplastic agents
Multiple Myeloma
Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Revision: 7
Authorised
2020-08-25
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BLENREP_ _100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION belantamab mafodotin 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 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 BLENREP is and what it is used for 2. What you need to know before you are given BLENREP 3. How BLENREP is given 4. Possible side effects 5. How to store BLENREP 6. Contents of the pack and other information 1. WHAT BLENREP IS AND WHAT IT IS USED FOR BLENREP contains the active substance BELANTAMAB MAFODOTIN, a _monoclonal antibody _ connected to an anticancer substance that can kill multiple myeloma cells. The monoclonal antibody is a protein designed to find the multiple myeloma cancer cells in your body and bind to them. Once attached to the cancer cells, the anticancer substance is released and kills the cancer cells. BLENREP is used to treat adults who have cancer of the bone marrow called multiple myeloma. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BLENREP _ _ DO NOT RECEIVE BLENREP: - if you are allergic to belantamab mafodotin or any of the other ingredients of this medicine (listed in section 6). CHECK WITH YOUR DOCTOR if you think this applies to you. WARNINGS AND PRECAUTIONS EYE PROBLEMS BLENREP can cause dry eyes, blurred vision or other eye problems. You should have an eye examination by an eye specialist before starting treatment and for the next three doses of BLENREP. Yo Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 BLENREP 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 100 mg of belantamab mafodotin. After reconstitution, the solution contains 50 mg belantamab mafodotin per mL. Belantamab mafodotin _ _ is an antibody-drug conjugate that contains belantamab, an afucosylated humanised monoclonal IgG1k antibody specific for B cell maturation antigen (BCMA), produced using recombinant DNA technology in a mammalian cell line (Chinese Hamster Ovary) that is conjugated with maleimidocaproyl monomethyl auristatin F (mcMMAF). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). Lyophilised white to yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BLENREP _ _ is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with BLENREP should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. Recommended supportive care Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, before the subsequent 3 treatment cycles, and as clinically indicated whilst on treatment (see section 4.4). Physicians should advise patients to administe Les hele dokumentet