ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

BESPONSA
Leukemias, lymphomas, and other hematologic cancers
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

BESPONSA Rx

Generic Name and Formulations:
Inotuzumab ozogamicin 0.9mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution; preservative-free.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for BESPONSA:

Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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.

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.

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).

Pharmacological Class:

CD22-directed antibody-drug conjugate.

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.

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.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs