Besponsa

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers

Besponsa Generic Name & Formulations

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