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besponsa package insert

besponsa package insert

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besponsa package insert
Welcome to BESPONSA® | BESPONSA®, Reference ID: 4140675 - Food and Drug Administration, Package leaflet: Information for the user BESPONSA 1 mg , BESPONSA (inotuzumab ozogamicin) RATIONALE FOR INCLUSION , DailyMed - BESPONSA- inotuzumab ozogamicin injection , Besponsa (inotuzumab ozogamicin) - Moda Health, HIGHLIGHTS OF PRESCRIBING INFORMATION Proteinuria: Monitor , , .
BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they: . 81% (88/109) of patients achieved remission * with BESPONSA compared to 29% (32/109) of patients with chemotherapy * Remission means that no leukemia cells can be seen when looking at bone marrow under a microscope.. Modify the dose of BESPONSA for toxicities (see Tables 2-4). BESPONSA doses within a treatment BESPONSA doses within a treatment cycle (i.e., Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but.
Package leaflet: Information for the user BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin 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 . Besponsa is an injectable cancer agent that works as a CD22-directed antibody drug conjugate (ADC). Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor. In clinical studies of BESPONSA in patients with relapsed or refractory ALL, the immunogenicity of BESPONSA was evaluated using an electrochemiluminescence (ECL)-based immunoassay to test for anti-inotuzumab ozogamicin antibodies. For patients whose sera tested positive for anti-inotuzumab ozogamicin antibodies, a cell-based luminescence assay was performed to detect neutralizing antibodies.. Moda Health Plan, Inc. Medical Necessity Criteria Page 3/3 3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) inotuzumab ozogamicin.. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use LENVIMA safely and effectively. See full prescribing information for. .
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