Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
blinatumomab
Amgen Europe B.V.
L01FX07
blinatumomab
Antineoplastic agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy (see section 4.2).,
Revision: 18
Authorised
2015-11-23
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BLINCYTO 38.5 MICROGRAMS POWDER FOR CONCENTRATE AND SOLUTION FOR SOLUTION FOR INFUSION blinatumomab 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. - Your doctor will also give you the following educational materials: - Educational Brochure for Patients and Caregivers, which contains important safety information that you need to be aware of before you are given BLINCYTO and during treatment with BLINCYTO. - Patient Card with contact details of your medical team and information when to call your doctor or nurse. Keep this Patient Card with you, at all times. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What BLINCYTO is and what it is used for 2. What you need to know before you use BLINCYTO 3. How to use BLINCYTO 4. Possible side effects 5. How to store BLINCYTO 6. Contents of the pack and other information 1. WHAT BLINCYTO IS AND WHAT IT IS USED FOR The active ingredient in BLINCYTO is blinatumomab. This belongs to a group of medicines called antineoplastic agents which target cancer cells. BLINCYTO is used to treat adults with acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B-lymphocyte” is growing out of control. This medicine works by enabling your immune system to attack and destroy these abnormal white blood cancer cells. BLINCYTO is used when acute lymphoblastic leukaemia has come back Lestu allt skjalið
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 BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 38.5 micrograms blinatumomab. Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL. Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate and solution for solution for infusion. BLINCYTO powder (powder for concentrate): White to off-white powder. Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome- negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. BLINCYTO is indicated as monotherapy fo Lestu allt skjalið