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besponsa pdf

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besponsa pdf
Welcome to BESPONSA® | BESPONSA®, BESPONSA® (inotuzumab ozogamicin) Fact Sheet, Reference ID: 4140675 - Food and Drug Administration, Package leaflet: Information for the user BESPONSA 1 mg , Besponsa® (inotuzumab ozogamicin) Medication , inotuzumab ozogamicin (Besponsa) - scottishmedicines.org.uk, SAFETY DATA SHEET - pfizer.com, MAKING REMISSION POSSIBLE - besponsa.com, BILLING AND CODING INFORMATION FOR HOSPITAL OUTPATIENT.
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: . BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age.. BESPONSA® (inotuzumab ozogamicin) is an antibody-drug conjugate (ADC) composed of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on cancer cells in almost all B-cell precursor acute lymphoblastic leukemia (ALL) patients, linked to a cytotoxic agent. i Each dose of.
9 /L. a . 50 × 10. 9 /L. a. Discontinue BESPONSA if low platelet count persists for greater than 28 days and is suspected to be related to BESPONSA. If prior to BESPONSA treatment. Page 1 of 10 Package leaflet: Information for the user BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin. Besponsa ® (inotuzumab ozogamicin) Medication Precertification Request Page 2 of 2 (All fields must be completed and legible for Precertification Review.). inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland. Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).. Trade Name: BESPONSA; INONZA Chemical Family: Monoclonal antibody Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product for the treatment of cancer Details of the Supplier of the Safety Data Sheet 2. HAZARDS IDENTIFICATION Classification of the Substance or Mixture GHS - Classification Germ Cell Mutagenicity: Category 2 Reproductive . BESPONSA® (inotuzumab ozogamicin) is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age..
 
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