Generic Name and Formulations:
Inotuzumab ozogamicin 0.9mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution; preservative-free.
Indications for BESPONSA:
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
See full labeling. Infuse over 1hr at rate of 50mL/hr. Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to dosing; or for cytoreduction: see full labeling. Cycle 1: 1.8mg/m2 as 3 divided doses on Day 1 (0.8mg/m2), Day 8 (0.5mg/m2), Day 15 (0.5mg/m2) for 3 weeks; may be extended to 4 weeks (eg, 7-day treatment-free interval starting on Day 21) if complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) achieved, and/or to allow recovery from toxicity. Subsequent cycles (if CR or CRi achieved): 1.5mg/m2 as 3 divided doses on Day 1 (0.5mg/m2), Day 8 (0.5mg/m2), Day 15 (0.5mg/m2) for 4 weeks; (if CR or CRi not achieved): 1.8mg/m2 as 3 divided doses on Day 1 (0.8mg/m2), Day 8 (0.5mg/m2), Day 15 (0.5mg/m2) for 4 weeks; discontinue if CR or CRi not achieved within 3 cycles. Patients proceeding to hematopoietic stem cell transplant (HSCT): treat for 2 cycles; may consider 3rd cycle if CR or CRi and minimal residual disease negativity not achieved after 2 cycles; if not proceeding to HSCT: may treat up to max 6 cycles. Dose modifications for toxicities: see full labeling.
Risk of hepatotoxicity, including veno-occlusive disease (VOD); monitor closely; permanently discontinue if VOD occurs. Increased risk of VOD in those who underwent HSCT after Besponsa treatment, ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of treatment cycles. Monitor liver function tests prior to and after each dose; interrupt, reduce, or permanently discontinue if elevated. Increased risk of post-HSCT non-relapse mortality rate; monitor for toxicities (eg, infection, VOD). History of or predisposition for QT prolongation, electrolyte disturbances; obtain ECGs and electrolytes prior to treatment, after initiation of drug known to prolong QTc, and periodically thereafter as indicated. Monitor CBCs, for signs/symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression; interrupt, reduce, or permanently discontinue if develops. Monitor for infusion-related reactions during and for at least 1 hour after infusion ends; interrupt and treat if occurs; permanently discontinue if severe or life-threatening. Embryo-fetal toxicity. Pregnancy (avoid); exclude status prior to initiation. Use effective contraception during therapy and for 8 months (females) or 5 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for at least 2 months after last dose).
Increased risk of QT interval prolongation with concomitant drugs known to prolong the QT interval or induce Torsades de Pointes; avoid, discontinue, or use alternative drugs.
CD22-directed antibody-drug conjugate.
Thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, hyperbilirubinemia; infusion-related reactions, impaired fertility.