For serum ALT and/or AST concentrations >2.5 times the ULN or total bilirubin concentrations >1.5 times the ULN (except in patients with Gilbert’s syndrome or hemolysis), interrupt therapy until ALT and AST recover to ≤2.5 times the ULN and total bilirubin concentrations recover to ≤1.5 times the ULN.1 If therapy is withheld for <7 days, administer next dose upon resolution of toxicity; however, adjust administration schedule to maintain a minimum of 6 days between doses.1 5 If therapy is withheld for ≥7 days but <14 days, omit next dose.1 If therapy is withheld for ≥14 days, reduce dosage by 25% in subsequent cycles; if further dosage reduction is necessary, reduce frequency of administration in subsequent cycles from 3 to 2 doses per cycle.1 If dosage modification (dosage reduction or reduced frequency) is not tolerated or elevated ALT, AST, or total bilirubin concentrations persist for >28 days despite interruption of therapy, permanently discontinue drug.1. Besponsa reference guide for safe and effective use from the American Society of Health-System Pharmacists (AHFS DI).. Apr 12: NCT01564784 an open-label, randomized PIII study of inotuzumab ozogamicin vs a defined investigator´s choice in 292 adult patients with relapsed or refractory CD22-positive ALL. The primary outcome is response to therapy (% of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). Inotuzumab ozogamicin will be given IV weekly (0.8-0.5 mg/m^2) 3 times per cycle. The comparator arms are: fludarabine, cytarabine and G-CSF or .