Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Inotuzumab ozogamicin
Pfizer Europe MA EEIG
L01FX
inotuzumab ozogamicin
Antineoplastic agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Revision: 9
Authorised
2017-06-28
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER BESPONSA 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION inotuzumab ozogamicin 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. - 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 BESPONSA is and what it is used for 2. What you need to know before you are given BESPONSA 3. How BESPONSA is given 4. Possible side effects 5. How to store BESPONSA 6. Contents of the pack and other information 1. WHAT BESPONSA IS AND WHAT IT IS USED FOR The active substance in BESPONSA is inotuzumab ozogamicin. This belongs to a group of medicines that target cancer cells. These medicines are called antineoplastic agents. BESPONSA is used to treat adults with acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells. BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed. BESPONSA acts by attaching to cells with a protein called CD22. Lymphoblastic leukaemia cells have this protein. Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells’ DNA and eventually kills them. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BESPONSA DO NOT USE BESPONSA IF YOU are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6). have previously had severe venoocclusive disease (a condition in which the blood vessels in the liver become damaged and blocked by blood clots) which was confirmed or have ongoing venoocclusive disease. hav Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT BESPONSA 1 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg inotuzumab ozogamicin. After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin. Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide. 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 cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph + ) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. When considering the use of BESPONSA as a treatment for relapsed or refractory B cell ALL, baseline CD22 positivity of > 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1). For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count ≤ 10,000/mm 3 is recommended prior to the first dose. Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.4). For patients with a high tumour burden, pre-medicati Przeczytaj cały dokument