Besponsa Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Besponsa Indications
Indications
Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Besponsa Dosage and Administration
Adults and Children
See full labeling. <1yr: not established. 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. ≥1yr: 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.
Besponsa Contraindications
Not Applicable
Besponsa Boxed Warnings
Boxed Warning
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 (for those who proceed to HSCT: monitor at least weekly during the 1st month post-HSCT, then less frequently thereafter); 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
Distribution
Volume of distribution: ~12 L. Plasma protein bound: ~97%.
Elimination
Half-life: 12.3 days. Clearance: 0.0333 L/h.
Besponsa Interactions
Interactions
Besponsa Adverse Reactions
Adverse Reactions
Besponsa Clinical Trials
See Literature
Besponsa Note
Not Applicable
Besponsa Patient Counseling
See Literature