Besponsa Generic Name & Formulations
Legal Class
Rx
General Description
Inotuzumab ozogamicin 0.9mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution; preservative-free.
Pharmacological Class
CD22-directed antibody-drug conjugate.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Besponsa Indications
Indications
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Besponsa Dosage and Administration
Adult
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.
Children
Not established.
Besponsa Contraindications
Not Applicable
Besponsa Boxed Warnings
Boxed Warning
Hepatotoxicity, including hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome. Increased risk of post-hematopoietic stem cell transplant (HSCT) non-relapse mortality.
Besponsa Warnings/Precautions
Warnings/Precautions
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).
Besponsa Pharmacokinetics
See Literature
Besponsa Interactions
Interactions
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.
Besponsa Adverse Reactions
Adverse Reactions
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.
Besponsa Clinical Trials
See Literature
Besponsa Note
Not Applicable
Besponsa Patient Counseling
See Literature