Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
loncastuximab tesirine
Swedish Orphan Biovitrum AB
L01FX22
loncastuximab tesirine
Antineoplastic agents
Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
Revision: 2
Authorised
2022-12-20
25 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZYNLONTA 10 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION loncastuximab tesirine 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 Zynlonta is and what it is used for 2. What you need to know before you are given Zynlonta 3. How you are given Zynlonta 4. Possible side effects 5. How to store Zynlonta 6. Contents of the pack and other information 1. WHAT ZYNLONTA IS AND WHAT IT IS USED FOR Zynlonta is a cancer medicine that contains the active substance loncastuximab tesirine. Zynlonta is used to treat adults with a certain type of cancer called DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) that: • has come back (relapsed) after two or more treatments, or that • did not respond to previous treatment (refractory). Diffuse large B-cell lymphoma is a cancer that develops from a type of white blood cell called B-lymphocyte (also called B-cell). Talk to your doctor or nurse if you have any questions about how Zynlonta works or why this medicine has been prescribed for you. HOW DOES ZYNLONTA WORK? Loncastuximab tesirine consist of 2 parts; an antibody (a type of protein designed to recognize and attach to a specific target) and a cytotoxic agent (a medicine able to kill cells, including cancer cells). The antibody in this medicine is designed to attach to CD19, a protein that is found Baca dokumen lengkapnya
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 Zynlonta 10 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 10 mg of loncastuximab tesirine. After reconstitution, each mL contains 5 mg of loncastuximab tesirine. Loncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate, consisting of a humanised IgG1 kappa monoclonal antibody, produced in Chinese Hamster Ovary cells by recombinant DNA technology, and conjugated to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxic alkylating agent, through a protease-cleavable valine-alanine linker. SG3199 attached to the linker is designated as SG3249, also known as tesirine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to off-white lyophilised powder, which has a cake-like appearance. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zynlonta must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients. Posology The recommended dose of Zynlonta is 0.15 mg/kg every 21 days for 2 cycles, followed by 0.075 mg/kg every 21 days for subsequent cycles until disease progression or unacceptable toxicity. _ _ _Premedication with dexame Baca dokumen lengkapnya